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CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Is there evidence of pain and distress reduction in pediatric patients who receive analgesic or anxiolytic interventions during minor invasive procedures in the emergency department compared to those patients who do not receive these interventions? 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Table of Contents Background/Significance_____________________________________________________________________3 Methodology_______________________________________________________________________________3 Summary of Literature Review________________________________________________________________5 Description of Decision Options/Interventions and the Level of Recommendation_________________________8 References_________________________________________________________________________________9 Authors__________________________________________________________________________________11 Acknowledgments__________________________________________________________________________11 Appendix I: Evidence Table__________________________________________________________________12 Appendix II: Other Resources Table____________________________________________________________25 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us 2 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Background/Significance Procedural pain is commonly associated with the emergency department (ED) visits of the pediatric population. Studies have demonstrated deficiencies in ED pain assessment and management, particularly with children (MacLean, Obispo, and Young, 2007; Young, 2005). One study of pediatric patients noted pain associated with procedures, with placement of an intravenous catheter being the most common source of pain cited (Cummings, Reid, Finley, McGrath, and Ritchie, 1996). Other minor invasive procedures frequently experienced by pediatric patients include bladder catheterization, venipuncture, immunizations, and gastric tube placement. These procedures contribute to the stress and anxiety of ED treatment for pediatric patients (Babl, Goldfinch, Mandrawa, Crellin, O’Sullivan, and Donath, 2009; Farion, Splinter, Newhook, Gaboury, and Splinter, 2008; and Newbury and Herd, 2009). It is recognized in pediatric emergency care that children experience avoidable pain and distress during invasive procedures (Mularoni, Cohen, DeGuzman, Mennuti-Washburn, Greenwald, and Simon, 2009; Young, 2005), and that this pain likely plays a significant role in shaping the pain response to future events in a negative fashion (Young, 2005). Barriers to adequate pain treatment for invasive procedures include the misperception that managing procedural pain is overly time-consuming and results in treatment delay, the misrepresentation of pain as anxiety, a lack of pain assessment, inadequate knowledge of pharmacological and nonpharmacological pain management, and fear of adverse reactions to medications (Spanos, Booth, Koenig, Sikes, Gracely, and Kim, 2008). A gap remains between the evidence regarding effective pain treatment and actual practice (Morgan and Ramponi, 2010; Papa and Zempsky, 2010). It is further noted that Papa and Zempsky (2010) studied nurse perception of pediatric peripheral venous access and the value of current techniques used to manage the associated pain. This Clinical Practice Guideline (CPG) focuses on needle-related procedures. The lack of published data on the treatment of procedural pain associated with urinary bladder catheterization and nasogastric tube placement in pediatric emergency department patients precludes recommendations for practice Methodology This CPG was created based on a thorough review and critical analysis of the literature following ENA’s Requirements for the Development of Clinical Practice Guidelines. Via a comprehensive literature search, all articles relevant to the topic were identified. The following databases were searched: PubMed, eTBLAST, CINAHL, The Cochrane Library, British Medical Journal, Agency for Healthcare Research and Quality, and the National Guideline Clearinghouse. Searches were conducted with the search terms “pediatrics,” “procedural pain,” “minor procedures,” “emergency department,” “intravenous cannulation,” and “pain,” using a variety of search combinations. Searches were limited to English language articles on human subjects from January 2005–October 2014. In addition, the reference lists in the selected articles were scanned for pertinent research findings. Research articles from emergency department settings, non-ED settings, position statements and guidelines from other sources were also reviewed. Clinical findings and levels of recommendations regarding patient management were made by the Clinical Practice Guideline Committee according to ENA’s classification of levels of recommendation for practice (Table 1). The articles reviewed to formulate the recommendations in this CPG are described in Appendix 1. 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us 3 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Table 1. Levels of Recommendation for Practice Level A recommendations: High • Reflects a high degree of clinical certainty • Based on availability of high quality level I, II and/or III evidence available using Melnyk & Fineout-Overholt grading system (Melnyk & Fineout-Overholt, 2005) • Based on consistent and good quality evidence; has relevance and applicability to emergency nursing practice • Is beneficial Level B recommendations: Moderate • Reflects moderate clinical certainty • Based on availability of Level III and/or Level IV and V evidence using Melnyk & Fineout-Overholt grading system (Melnyk & Fineout-Overholt, 2005) • There are some minor or inconsistencies in quality evidence; has relevance and applicability to emergency nursing practice • Is likely to be beneficial Level C recommendations: Weak • Level V, VI and/or VII evidence available using Melnyk & Fineout-Overholt grading system (Melnyk & Fineout-Overholt, 2005) - Based on consensus, usual practice, evidence, case series for studies of treatment or screening, anecdotal evidence and/or opinion • There is limited or low quality patient-oriented evidence; has relevance and applicability to emergency nursing practice • Has limited or unknown effectiveness Not recommended for practice • No objective evidence or only anecdotal evidence available; or the supportive evidence is from poorly controlled or uncontrolled studies • Other indications for not recommending evidence for practice may include: ◦◦ Conflicting evidence ◦◦ Harmfulness has been demonstrated ◦◦ Cost or burden necessary for intervention exceeds anticipated benefit ◦◦ Does not have relevance or applicability to emergency nursing practice • There are certain circumstances in which the recommendations stemming from a body of evidence should not be rated as highly as the individual studies on which they are based. For example: ◦◦ Heterogeneity of results ◦◦ Uncertainty about effect magnitude and consequences, ◦◦ Strength of prior beliefs ◦◦ Publication bias 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us 4 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Summary of Literature Review Pain Scales Measurement of pain in the pediatric population presents challenges for nurses. Before one can proceed with adequate pain management, adequate pain assessment is required. There are three standard dimensions of pain assessment used: 1) self-report of pain intensity, 2) behavioral reactions, and 3) physiological reactions (Young, 2005). Because pain is always subjective, self-report is the standard assessment parameter used. Pain measurement should use a valid scale based on the child’s age, cognitive level, type of pain, and situation. No single scale is useful for all children with all types of pain. Children are usually able to differentiate a few levels of pain intensity by the age of three years (Young, 2005). Two commonly used pain assessments that incorporate self-reporting are the visual analog scale and the faces scale. The visual analog scale, which can be used by children as young as seven years of age, is a 10-cm line ranging from no pain to the worst pain possible. The visual analog scale is further divided from 0 to 100 mm. Young (2005) identifies a change of 10 to 13 mm as the minimum clinically significant change (as cited in Gallagher, Liebman, and Bijur, 2001; Powell, Kelly, and Williams, 2001). The faces scale consists of five to nine faces ranging from neutral or no pain to sad or distressed. A change of one face is considered clinically significant (Bulloch and Tenenbein, 2002). Behavioral rating scales use facial expressions, torso movements, kicking, crying, and verbal protest. Poor correlation with selfreported pain is sometimes seen as children may be able to control their own behavior (Young, 2005). Behavioral rating scales can be used on non-verbal children and with developmentally delayed children. Pain management has been inadequately studied in the acute setting. There are no published data regarding the validity of pediatric pain scales specific to ED patients. Psychological Interventions Psychological interventions include breathing exercises, such as blowing the hurt away, and suggestion, such as describing something to the child that would make them believe the procedure would hurt less (Chambers, Taddio, Uman, and McMurtry, 2009; Uman, Birnie, Noel, Parker, Chambers, McGrath, and Kisely, 2006). Chambers et al. (2009) goes on to define distraction in terms of childdirected distraction, such as video, music, or story playing; parent-led distraction, where parents are instructed on how to distract the child; or nurse-led distraction, where nurses are instructed on how to distract the child. Parent coaching is an intervention where parents are instructed to provide assistance to the child using techniques such as humor, nonprocedural talk, toys, pacifier, or rocking (Chambers, et al., 2009). Uman et al. (2006) defines distraction techniques including counting, music, and suggestion as a cognitive intervention. Combined cognitive–behavioral interventions are techniques aimed at modifying emotions and behaviors (Chambers, et al., 2009; Uman et al., 2006). Behavioral Interventions Multiple studies address the efficacy of cognitive–behavioral interventions for needle-related procedures in children and adolescents. Cognitive interventions researched include various distraction methods, such as music, preparation and education, and suggestion. Behavioral interventions include behavioral distraction through virtual reality, audiovisual distraction, games, muscle relaxation, and breathing exercises. Chambers, et al. (2009) conducted a meta-analysis of randomized and quasi-randomized controlled trials to examine the efficacy of different psychological interventions during immunizations in children 0 through 18 years of age. The researchers concluded that breathing exercises are an effective intervention for reducing distress in the patient, observer, and nurse. Distraction can either be directed by the child (e.g., watching a video or listening to music with headphones), parent (i.e., parents educated on how to provide age-appropriate distraction), or nurse (i.e., a nurse educated on how to provide age-appropriate distraction). Chambers et al. (2009) found sufficient evidence to support child-directed distraction as a method to reduce selfreported pain during immunizations. Both parent- and nurse-directed distraction did have an effect on reducing observer-rated pain, but the results were not considered statistically significant (Chambers et al., 2009). Uman et al. (2006) conducted a systematic review of 28 studies and supports the use of distraction as a method of reducing pain and anxiety in needle-related procedures. One study (Hartling, Newton, Liang, Jou, Hewson, Klassen, and Curtis, 2013) looked at the emerging use of technology in providing distraction and specifically evaluated the use of music as a distraction technique in a randomized trial of 3 to 11 year olds undergoing IV placement. Children were randomly assigned to either the music or non-music group used during the process of IV placement, 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us 5 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients including site preparation. While the sample size was small, children who had music as a distraction had significantly less distress during the IV placement. The healthcare providers rated the procedure as very easy to perform and more satisfactory than when music was not used. Non-significant but improved parent satisfaction with the use of music was also observed. Gold, Kim, Kant, Joseph, and Rizzo (2006) conducted research on children age 7–12 years requiring intravenous line placement. Children were randomly assigned to facility standard of care (topical anesthetic) or to the use of a virtual reality simulator headset. Subjects randomized to virtual reality: 1) reported less affective pain changes across the procedure, 2) had no evidence of motion sickness related to the simulator, and 3) expressed twice the satisfaction with pain management as compared with the control group. Coaching is another cognitive–behavioral intervention studied by numerous researchers. Chambers et al. (2009) found that parent coaching is effective in reducing observer-rated distress, but not other measures of pain or distress during immunizations. Uman et al. (2006) found that nurse coaching combined with distraction is effective in reducing behavioral measures of distress. Specifically: • Information and preparation are effective in reducing observer-reported child pain and pulse rate • Hypnosis is effective in reducing self-reported pain, self-reported distress, and behavioral measures of distress • Memory alteration is effective in reducing diastolic BP • Combined cognitive–behavioral interventions are effective in reducing observer-reported distress and behavioral measures of child distress • Parent positioning with distraction is effective in reducing observer-reported child distress (Uman et al., 2006) Topical Pharmacological Interventions Ethyl Vinyl Chloride The use of ethyl vinyl chloride in the ED has decreased over the past decade because of handling and storage requirements (The Joint Commission, 2013). Research on the use of ethyl vinyl chloride to reduce pain associated with pediatric needle procedures is limited and its effectiveness appears to be related to patient age. Davies and Molloy (2006) found the opinion of nurses was that children less than nine years of age did not tolerate the cold sensation associated with ethyl vinyl chloride spraying. Costello, Ramundo, Christopher, and Powell (2006) found that ethyl vinyl chloride vapocoolant spray failed to measurably reduce pain associated with IV cannulation in children aged 9–18 years. Davies and Molloy found that ethyl vinyl chloride offered a significant reduction in pain in children aged 5–13 years who required repeated needle procedures. Other Vapocoolants Farion et al. (2008) researched the effects of the Pain Ease® vapocoolant spray with children aged 6–12 years who required urgent intravenous catheterization. The achieved 15 mm pain reduction on the visual analogue scale was felt by the authors to be of clinical significance. This modest but significant decrease was accompanied by an increased rate of successful cannulation at first attempt compared to the placebo. Vibration with Local Application of Ice A novel application of a device that combines local ice application with vibration was examined by Baxter and colleagues (2011). The Buzzy (MMJ Labs, Atlanta, GA) was applied proximal to the planned location of the IV and remained in vibration mode during the catheterization. Researchers compared this with vapocoolant or distraction in this randomized trial among children 4–18; success rates with the vibration plus ice group were three times higher for first-attempt cannulations, with significantly lower pain scores reported by parents and observers. Another important benefit of the device is decreased time to intervention. The use of topical anesthetics such as creams requires 30–60 minutes for absorption, while the Buzzy can be used after as little as 3 minutes of training time for the patient. Median time to IV placement in this study was 5.43 minutes. Local Application of Ice Movahedi, Rostami, Salsali, Keikhaee, and Moradi (2006) studied the effect on pain-related responses of local refrigeration with ice prior to venipuncture in children aged 6–12 years. The researchers found that local application of ice provided effective pain relief. 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us 6 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Pacifiers and Sucrose In a systematic review published in 2011, Hatfield, Chang, Bittle, Deluca, and Polomano examined the randomized controlled trials published from 1982 through 2009. A total of 46 studies were included in the review. All the studies had convenience samples and, with the exception of one study, were double-blind, placebo-controlled trials. Gender did not significantly affect the findings. Sucrose concentrations tested included 7.5, 12, 24, and 50%. The doses most commonly given were 0.12 g and 0.24 g, but ranged from 0.012 g to 1.0 g. Small (0.12 g), repeated doses of sucrose were moderately effective in reducing pain scores in neonates and infants, with doses greater than 0.5 g demonstrating no increased relief with increasing dose. Providing the sucrose up to 2 minutes prior to the painful procedure demonstrated relief and decreased cry duration, calming up to 5–10 minutes after the stimulus. The method of sucrose delivery varied, including by syringe, pacifier, or nasogastric tube. Interpretation of the pacifier results is complicated by inconsistency in the number of times the pacifier was dipped in the sucrose. Overall safety of administration was well established, and few studies reported any adverse events. Any that occurred were minor and resolved spontaneously. Local Anesthetic Preparations Multiple studies address the use of various lidocaine preparations for needle-related procedures in different pediatric age groups. Lander, Weltman, and So (2006) conducted a systematic review of six clinical trials on the effectiveness of Eutectic Mixture of Local Anesthetic (EMLA) versus amethocaine (tetracaine) for pain reduction in needle-related procedures with children aged three months to 15 years. The reviewers found that tetracaine was significantly favored over EMLA in patients’ self-reported pain ratings, but when observers reported pain differences, they found both products to be equally effective. Newbury and Herd (2009) compared the cannulation success rate for EMLA versus amethocaine. There was no statistical difference in the frequency of first-time successful cannulations. Sethna, Verghese, Hannallah, Solodiuk, Zurakowski and Berde (2005) compared a topical lidocaine patch (S-Caine Patch ™) to a placebo in children aged 3–17 years. The researchers found that 59% of those in the intervention group reported no pain compared with 20% in the placebo group. In a similar study, Singer, Taira, Chisena, Gupta, and Chipley (2008) found that application of a topical lidocaine/tetracaine patch resulted in a modest reduction in the pain of IV cannulation in children aged 3–17 years. Taddio, Soin, Schuh, Koren, and Scolnik (2005) evaluated the cannulation success rate using topical lidocaine versus a placebo. The results showed a significant difference (74% versus 55%) in cannulation at the first attempt for those in the intervention group. The results suggest that not only are topical lidocaine preparations capable of decreasing pain, but also of increasing the cannulation success rate. Subdermal Local Anesthetic with Needle-free Delivery Research has also been conducted on the use of two needle-free systems that deliver local anesthetic into the dermal layers with a carbon dioxide injector. The two devices did not affect the success rate of IV cannulation on first attempt. Spanos et al. (2008) studied the J-Tip application of 1% buffered lidocaine prior to peripheral intravenous (PIV) insertion and compared its effect with that of ELA Max in the pediatric ED. Patient reports of pain were statistically significantly lower in the J-Tip group. Blinded observers also identified clinically significant differences in terms of less pain — defined as a difference on the visual analogue scale of 10 mm — following J-Tip jet injection, although the findings were not statistically significant. Nurses who inserted the PIV reported similar scores for the two groups in both ease of insertion and overall satisfaction. Jimenez, Bradford, Seidel, Sousa, and Lynn (2006) compared 1% buffered lidocaine with EMLA when they were applied via J-tip prior to peripheral IV cannulation. There was a significant difference between the groups, with 84% of patients reporting no pain at the time of J-Tip lidocaine application versus 61% in the EMLA group. It is noted, however, that 40% of the patients had EMLA applied for less than the recommended 60 minutes. However, when a subset of the original EMLA group was reviewed, all of which had application times equal to or greater than the recommended 60 minutes, the difference remained significant. A third study examined the use of a needle-free injection of lidocaine or saline into the subcutaneous tissue prior to lumbar puncture in a randomized controlled trial of infants younger than three months (Ferayorni, Yniguez, Bryson and Bulloch, 2012). The lidocaine group was noted to have a significantly shorter duration of cry and lower pain scores. 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us 7 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Description of Decision Options/Interventions and the Level of Recommendation Conclusions and recommendations about management of pain and distress associated with venipuncture, IV cannulation, and immunization in pediatric patients in the emergency department: 1. Biobehavioral Interventions: i. There is sufficient evidence to support the efficacy of developmentally appropriate distraction, coaching with distraction, cognitive behavioral therapy, hypnosis, and breathing exercises in reducing pain and distress. (Level A: High) (Chambers et al., 2009; Uman et al., 2006; Hartling et al., 2013). ii. There is sufficient evidence to support the effectiveness of patient information/ preparation in combination with distraction in decreasing pain and distress. (Level A: High) (Uman et al., 2006). 2. Dermal Anesthetic Preparations (Vapocoolants and Transdermal Preparations): i. Ethyl vinyl chloride may be effective in relieving pain associated with venipuncture. (Level C: Weak) (The Joint Commission, 2013; Davies and Molloy, 2006; Costello et al., 2006). ii. Pentafluoropropane and tetrafluoroethane (Pain Ease®) induces a moderate reduction in pain in patients 6–12 years of age undergoing IV cannulation. (Level B: Moderate) (Farion et al., 2008). iii. All transdermal forms of lidocaine/tetracaine (amethocaine) are effective in reducing pain associated with IV cannulation, venipuncture, and immunization. Preparations in the form of cream or patches tend to take longer to exert an effect (60 minutes or more), which makes them less feasible for use in the ED environment. (Level A: High) (Lander, Weltman, and So, 2006; Newbury and Herd, 2009; Sethna et al., 2005; Singer et al., 2008; Taddio et al., 2005). 3. Subdermal Local Anesthetic with Needle-free Delivery: i. The use of a needleless injection device (e.g., J-Tip®) as a delivery method for lidocaine is superior to other forms of preparation when rapid local anesthesia is. (Level A: High) (Spanos et al., 2008; Jimenez et al., 2006; Ferayorni et al., 2012). 4. Local Application of Ice: i. Local application of ice decreases the pain and distress associated with venipuncture. (Level B: Moderate) (Movahedi et al., 2006). 5. Pacifiers and Sucrose: i. Pacifiers are effective analgesia for infants 0 to 3 months of age undergoing venipuncture. (Level B: Moderate) (Hatfield et al., 2009). ii. Evidence suggests that sucrose is beneficial as a form of analgesia in children from zero to three months of age; no benefit has been demonstrated for children older than three months. (Level A: High) (Hatfield et al., 2009; Ferayorni et al., 2012). 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us 8 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. Babl, F. E., Goldfinch, C., Mandrawa, C., Crellin, D., O’Sullivan, R., & Donath, S. (2009). Does nebulized lidocaine reduce the pain and distress of nasogastric tube insertion in young children? A randomized, double-blind, placebo-controlled trial. Pediatrics, 123(6), 1548–1555. doi:10.1542/peds.2008-1897 Baxter, A. L., Cohen, L. L., McElvery, H. L., Lawson, M. L., & von Baeyer, C. L. (2011). An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatric Emergency Care, 27(12), 1151–1156. doi:10.1097/PEC.0b013e318237ace4 Bulloch, B., & Tenenbein, M. (2002). Validation of 2 pain scales for use in the pediatric emergency department. Pediatrics, 110(3), e33. Chambers, C. T., Taddio, A., Uman, L. S., McMurtry, C. M., & HELPinKIDS Team. (2009). Psychological interventions for reducing pain and distress during routine childhood immunizations: A systematic review. Clinical Therapeutics, 31, Supplement 2, S7–S103. doi:10.1016/j.clinthera.2009.07.023 Costello, M., Ramundo, M., Christopher, N. C., & Powell, K. R. (2006). Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children. Clinical Pediatrics, 45(7), 628–632. Cummings, E. A., Reid, G. J., Finley, G. A., McGrath, P. J., & Ritchie, J. A. (1996). Prevalence and source of pain in pediatric inpatients. Pain, 68(1), 25–31. doi:10.1016/S0304-3959(96)03163-6 Davies, E. H., & Molloy, A. (2006). Comparison of ethyl chloride spray with topical anaesthetic in children experiencing venepuncture. Paediatric Nursing, 18(3), 39–43. Retrieved from http://journals.rcni.com/doi/pdfplus/10.7748/paed2006.04.18.3.39.c8136 Farion, K. J., Splinter, K. L., Newhook, K., Gaboury, I., & Splinter, W. M. (2008). The effect of vapocoolant spray on pain due to intravenous cannulation in children: A randomized controlled trial. Canadian Medical Association Journal, 179(1), 31–36. doi:10.1503/cmaj.070874 Ferayorni, A., Yniguez, R., Bryson, M., & Bulloch, B. (2012). Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture. Pediatric Emergency Care, 28(7), 687–690. doi:10.1097/PEC.0b013e31825d210b Gallagher, E. J., Liebman, M., & Bijur, P. E. (2001). Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Annals of Emergency Medicine, 38(6), 633–638. Gold, J. I., Kim, S. H., Kant, A. J., Joseph, M. H., & Rizzo, A. (2006). Effectiveness of virtual reality for pediatric pain distraction during IV placement. CyberPsychology and Behavior, 9(2), 207–212. doi:10.1089/cpb.2006.9.207 Hartling, L., Newton, A. S., Liang, Y., Jou, H., Hewson, K., Klassen, T. P., & Curtis, S. (2013). Music to reduce pain and distress in the pediatric ED: A randomized clinical trial. JAMA Pediatrics, 167(9), 826–835. doi:10.1001/jamapediatrics.2013.200 Hatfield, L. A., Chang, K., Bittle, M., Deluca, J., & Polomano, R. C. (2011). The analgesic properties of intraoral sucrose: An integrative review. Advances in Neonatal Care, 11(2), 83–92. doi:10.1097/ANC.0b013e318210d043 Jimenez, N., Bradford, H., Seidel, K. D., Sousa, M., & Lynn, A. M. (2006). A comparison of a needle-free injection system for local anesthesia versus EMLA for intravenous catheter insertion in the pediatric patient. Anesthesia and Analgesia, 102(2), 411–414. Lander, J. A., Weltman, B. J., & So, S. S. (2006). EMLA and amethocaine for reduction of children’s pain associated with needle insertion. Cochrane Database of Systematic Reviews, 19(3), CD004236. doi:10.1002/14651858.CD4236.pub2 MacLean, S., Obispo, J., & Young, K.D. (2007). The gap between pediatric emergency department procedural pain management treatments available and actual practice. Pediatric Emergency Care. 23:2, 87-93. Melnyk, B. M., & Fineout-Overholt, E. (Eds.). (2005). Evidence-based practice in nursing and healthcare: A guide to best practice. Philadelphia, PA: Lippincott Williams & Wilkins. Morgan, R. M., & Ramponi, D. (2010). Promotion of a practice change regarding pediatric procedural pain management on a national level. Virginia Henderson International Nursing Library e-Repository. Retrieved from http://www.nursinglibrary.org/vhl/handle/10755/171010 Movahedi, A. F., Rostami, S., Salsali, M., Keikhaee, B., & Moradi, A. (2006). Effect of local refrigeration prior to venipuncture on pain related responses in school age children. Australian Journal of Advanced Nursing, 24(2), 51–55. Mularoni, P. P., Cohen, L. L., DeGuzman, M., Mennuti-Washburn, J., Greenwald, M., & Simon, H. K. (2009). A randomized clinical trial of lidocaine gel for reducing infant distress during urethral catheterization. Pediatric Emergency Care, 25(7), 439–443. doi:10.1097/PEC.0b013e3181ab7885 Newbury, C., & Herd, D. W. (2009). Amethocaine versus EMLA for successful intravenous cannulation in a children’s emergency department: A randomized controlled study. Emergency Medicine Journal, 26(7), 487–491. doi:10.1136/emj.2008.065110 Papa, A. & Zempsky, W. (2010). Nurse perceptions of the impact of pediatric peripheral venous access pain on nurse and patient satisfaction: Results of a national survey. Advanced Emergency Nursing Journal, 32(3), 226–233. Powell, C. V., Kelly, A. M., & Williams, A. (2001). Determining the minimum clinically significant difference in visual analog pain score for children. Annals of Emergency Medicine, 37(1), 28–31. Sethna, N. F., Verghese, S. T., Hannallah, R. S., Solodiuk, J. C., Zurakowski, D., & Berde, C. B. (2005). A randomized controlled trial to evaluate S-Caine patch for reducing pain associated with vascular access in children. Anesthesiology, 102(2), 403–408. Singer, A. J., Taira, B. R., Chisena, E. N., Gupta, N., & Chipley, J. (2008). Warm lidocaine/tetracaine patch versus placebo before pediatric intravenous cannulation: A randomized controlled trial. Annals of Emergency Medicine, 52(1), 41–47. Spanos, S., Booth, R., Koenig, H., Sikes, K., Gracely, E., & Kim, I. K. (2008). Jet injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: A randomized controlled trial. Pediatric Emergency Care, 24(8), 511–515. doi: 10.1097/ PEC.0b013e31816a8d5b Taddio, A., Soin, H. K., Schuh, S., Koren, G., & Scolnik, D. (2005). Liposomal lidocaine to improve procedural success rates and reduce procedural pain among children: A randomized controlled trial. Canadian Medical Association Journal, 172(13), 1691–1695. doi:10.1503/cmaj.045316 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us 9 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients 28. The Joint Comission. (2013). Revisions to the Medication Management Standards Regarding Sample Medications (December 18). Prepublication Requirements. Retrieved from http://www.jointcommission.org/assets/1/6/SampleMedications_HAP.pdf 29. Uman, L. S., Birnie, K. A., Noel, M., Parker, J. A., Chambers, C. T., McGrath, P. J., & Kisely, S. R. (2006). Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database of Systematic Reviews, 10, CD005179. doi:10.1002/14651858.CD005179.pub2. 30. Young, K.D. (2005). Pediatric procedural pain. Annals of Emergency Medicine. 45:2, 160-171 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us 10 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Authors 2014 ENA Clinical Practice Guideline Committee Anne M. Renaker, DNP, RN, CNS, CPEN Jennifer Williams, PhD, RN, CNS, CEN, CCRN, Chairperson Sherri-Lyne Almeida, DrPH, MSN, MEd, RN, CEN, FAEN Susan Barnason, PhD, RN, APRN, CNS, CS, CEN, CCRN, FAEN, FAAN Constance Bowen, DNP, RN, APRN, CEN, CCNS, CCRN Carla Brim, MN, RN, CNS, CEN Janis M. Farnholtz-Provinse, MS, RN, CNS, CEN Suzanne N. Franzoni-Kleeman, MSN, BSN, RN, CEN Caitlin Healy, BSN, RN, CEN Marylou Killian, DNP, MS, RN, CEN, FNP-BC Cindy Lefton, PhD, RN Sherry Leviner, MSN, RN, CEN David R. McDonald, MSN, RN, APRN, CEN, CCNS Mary Alice Vanhoy, MSN, RN, CEN, CPEN, NREMT-P Amy S. Waunch, MSN, BSN, RN, FNP, CEN Mary E. Zaleski, MSN, RN, CEN ENA 2014 Board of Directors Liaison Ellen Encapera, RN, CEN ENA 2015 Board of Directors Liaison Jean A. Proehl, MN, RN, CEN, CPEN, FAEN ENA 2015 Staff Liaisons Lisa Wolf, PhD, RN, CEN, FAEN, Director: Institute for Emergency Nursing Research (IENR) Altair M. Delao, MPH, Senior Associate: IENR Acknowledgments ENA would like to acknowledge the following members of the 2015 IENR Advisory Council for their review of this document: Margaret Carman, DNP, MSN, RN, ACNP-BC, ENP-BC Gail Lenehan, EdD, MSN, RN, FAEN, FAAN Martha McDonald, PhD, RN, CEN, CCNS, CCRN, CNE Developed: December 2010 Revised: August 2015 © Emergency Nurses Association, 2015. ENA’s Clinical Practice Guidelines (CPGs), including the information and recommendations set forth herein (i) reflects ENA’s current position with respect to the subject matter discussed herein based on current knowledge at the time of publication; (ii) is only current as of the publication date; (iii) is subject to change without notice as new information and advances emerge; and (iv) does not necessarily represent each individual member’s personal opinion. The positions, information and recommendations discussed herein are not codified into law or regulations. Variations in practice and a practitioner’s best nursing judgment may warrant an approach that differs from the recommendations herein. ENA does not approve or endorse any specific sources of information referenced. ENA assumes no liability for any injury and/or damage to persons or property arising from the use of the information in this Clinical Practice Guidelines. 915 Lee Street, Des Plaines, IL 60016-6569 ¡ 800.900.9659 ¡ www.ena.org ¡ Follow us 11 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis Findings/Implications Quality of Evidence Level of Evidence I I Psychological/Cognitive Behavioral Interventions Chambers, C.T., Taddio, A., Uman, L.S., McMurty, C.M.; HELPinKIDS Team (2009). Psychological interventions for reducing pain and distress during routine childhood immunizations: a systematic review. Clinical Therapeutics, Vol 31, Supplement B, S77 – S103 The object of this review was to identify and synthesize randomized controlled trials and quasi-RCTs that examine the efficacy of different psychological interventions for reducing injection pain and distress in children 0 to 18 years of age during routine childhood immunizations. Primary outcome was pain or distress experienced by the child during vaccine injection as assessed by the child, or by others (parent, nurse, physician, observer) . RCT and quasi-RCT. Children 0 to 18 years under going immunization in any setting were reviewed; 1380 infants and children included. Age ranged 1 month to 11 years. Of the 28 trials included in the previous review by Uman et al, 10 met criteria to also be included in this current review. An additional 10 trials were identified giving a total of 20 unique trials for systematic review. 1. Breathing exercises (blowing the hurt away) 2. Suggestion (telling the child something that would make them believe that the procedure would hurt less). 3. Child-directed distraction (directed at the child, such as video, music or story played via headphones). 4. Parent-led distraction (parents instructed on how to distract the child). 5. Nurse-led distraction (nurses instructed on how to distract the child using age-appropriate toys). 6. Parent coaching (parents instructed to provide assistance to the child using different techniques, not limited to distraction). 7. Combined cognitive-behavioral interventions (techniques aimed at modifying emotions, behaviors, and cognitions). 12 Breathing exercises: evidence suggests breathing exercises were effective in reducing children’s self-reported pain, observer-rated distress, and nurse-reported distress. Breathing exercises were effective in reducing children’s self-reported distress in 1 of 2 studies. Suggestion: no evidence that suggestion was effective in reducing pain from immunization. Child-directed distraction: effective in reducing self-reported pain. Observer-rated pain appeared to be lower with this intervention, but the difference was not statistically significant. Parent-led distraction: effective in reducing observer-rated distress, but not other measures of pain or distress during immunization. Nurse-led distraction: effective in reducing observer-rated distress and parent and nurse ratings of distress. Evidence from one study indicated a reduction in self-reported pain. Parent coaching: effective in reducing observer-rated distress, but not other measures of pain or distress during immunizations. Combined cognitive-behavioral interventions: effective in reducing children’s self-reported pain, observer-rated distress, and parent-rated distress. Findings that these two parent-targeted interventions were ineffective are surprising. This may be related to brief parent training or instructions. Note of Caution: The focus of this report is on trials with infants and school-aged children; no trials of psychological interventions for reducing pain and distress associated with immunizations in adolescents were identified. Overall quality of the trials included in this systematic review was felt to be poor by the authors, with 90% of the trials having a high risk for bias. This is primarily related to the inherent difficulties with blinding participants. CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Research/Purpose Questions/Hypothesis Design/Sample Setting Gold, J.I., Kim, S.H., Kant, A.J., Joseph, M.H., Rizzo, A. (2006). Effectiveness of virtual reality for pediatric pain distraction during IV placement. Cyberpsychology and Behavior, 9(2), 207-212. To test the efficacy and suitability of virtual reality as a pain distraction for pediatric IV placement. Randomized Trial of virtual reality versus standard of care (topical anesthetic). Children aged 7-12 requiring IV placement for an outpatient CT or MR. Visual Analog Scales Wong Baker FACES Scale Faces Pain Scale-Revised Childhood Anxiety Sensitivity Index Child Simulator Sickness Questionnaire and patient/ parent Satisfaction questionnaires. Children randomized to virtual reality had less affective pain changes across the procedure, no evidence of simulator sickness, and higher satisfaction (twice as satisfied) of pain management when compared to the control group. Hartling, L. (2013). Music to reduce pain and distress in the pediatric ED: A randomized clinical trial. JAMA Pediatrics, 167(9), 826-35. Uman, L.S., Chambers, C.T., McGrath, P.J., Kisely, S.R. (2006). Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database of Systematic Reviews 2006, Issue 4, Art. No. CD005179. DOI: 10.1002/14651858.CD005179. pub2. to compare music with standard care to manage pain and distress 2-arm parallel, randomized, clinical trial with blinded assessment of the primary outcome N = 42 (3-11 yrs undergoing IV placement) IRB approval Mann-Whitney U test, additional model-based analyses (multiple linear regression). Additional analyses were performed for a subgroup with nonzero OSBD-R scores - all statistical tests were performed at a significance level of .05 (2-sided). Music may have a positive impact on pain and distress in kids undergoing IV placement. Benefits observed for the parents and health care providers have important clinical implications. Reference Variables/Measures Analysis 13 Findings/Implications Quality of Evidence Level of Evidence I II III IV CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Uman, L.S., Chambers, C.T., McGrath, P.J., Kisely, S.R. (2006). Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database of Systematic Reviews 2006, Issue 4, Art. No. CD005179. DOI: 10.1002/14651858.CD005179. pub2. Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis To assess the efficacy of cognitive-behavioral psychological interventions for needle-related procedural pain and distress in children and adolescents. Only RCTs with at least 5 participants in each study arm comparing a psychological intervention group with a control or comparison group. Cognitive-behavioral therapy (CBT) is defined as a group of treatment procedures aims at identifying and modifying faulty thought processes, attributes, attributions, and problem behaviors. CBT interventions for pain management are aimed at assisting the child to develop and apply coping skills in order to manage the pain and distress, and when developmentally appropriate, to help the child comprehend how thoughts and behaviors can alter their experience of pain. Design: RCT N = 28 trials witz 1951 participants (1039 participants in a treatment condition ; 951 in a control condition. All published before 2005. Population: children and adolescents age 2-19 yrs undergoing needle-related procedures. Justification for not including children < 2yrs of age is that the majority of psychological interventions being examined in this review are either not appropriate for use with infants or are qualitatively different when applied to infants. Needle procedures: Immunizations, venipuncture/blood draw, lumbar puncture, IV insertion, bone marrow aspiration, IM injections. Diagnostic status of children: Healthy, oncology pt with leukemia/lymphoma, various medical conditions Interventions: Distraction, distraction + coping skills, distraction + suggestion, nurse coaching + parent/ child training, nurse coaching + distraction, nurse coaching, coping skills training, suggestion, preparation / procedure info, blowing out air, virtual reality distraction, videotape modeling + parent participation, modeling, hypnosis, parent assisted behavioral interventions, memory alteration Two review authors independently extracted data and assessed trial quality. Studies were coded for quality using the Oxford Quality Scale. Standardized mean deviations (SMD) with 95% CI were computed for all analyses. Interventions classified as: Cognitive interventions (cognitive distraction-counting, music, hypnosis, preparation/education, suggestion); Behavioral interventions (behavioral distraction-videotapes, games, muscle relaxation, breathing exercises; Cognitive-behavioral (combined) interventions (at least one of each of the other two groups). 14 Findings/Implications Efficacy of cognitive-behavioral psychological intervention: Overall, there is sufficient evidence to support the efficacy of distraction, hypnosis, and combined CBT in reducing pain and distress in children and adolescents undergoing needle procedures. Information and Preparation: There is also evidence to support the efficacy of information/preparation, and combined interventions which use distraction as one of the components. Other Interventions: There was insufficient evidence to provide strong evidence for or against the efficacy of the other interventions assessed in this review. -Distraction is effective in reducing self-reported pain -Information/preparation is effective in reducing observer-reported child pain and pulse rate -Hypnosis is effective in reducing self-reported pain, self-reported distress, and behavioral measures of distress -Memory alteration is effective in reducing diastolic BP -Combined cognitive-behavioral interventions are effective in reducing observer reported distress and behavioral measures of child distress -Nurse coaching + distraction is effective in reducing behavioral measures of distress -Parent positioning + distraction is effective in reducing observer-reported child distress -Distraction + suggestion is effective in reducing self-reported pain Quality of Evidence Level of Evidence I I CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis Findings/Implications Quality of Evidence Level of Evidence II II Ethyl Vinyl Chloride Costello, M., Ramundo, M., Christopher, N.C., Powell, K.R. (2006). Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children. Clinical Pediatrics, 45: 628-632. 1. To determine the effect of ethyl vinyl chloride vapocoolant spray on pain reported by children undergoing IV cannulation. 2. To determine whether there is an effect on cannulation success rates when compared to those receiving isopropyl alcohol spray or no pretreatment. Randomized, double-blinded, placebo-controlled trial Children 9 to 18 years seen in a pediatric ED requiring IV cannulation. Enrolled subjects had distraction techniques and preprocedural educational interventions regardless of the group they were assigned. Spray applied for 5 seconds or until skin blanched. 22G 1 inch IV catheter. Rate pain based on 100 cm VAS Failed starts recorded pain only after first attempt. Recorded pt demographics, indications for IV cannulation, time from IV insertion to VAS score, cannulation site, success or failure of first cannulation attempt, history of prior IV cannulation or blood draws, memory of prior cannulation attempts. 15 Effect of ethyl vinyl chloride vapocoolant spray on pain: Ethyl vinyl chloride vapocoolant spray failed to measurably reduce pain associated with IV cannulation when compared to those pretreated with isopropyl alcohol spray or receiving not intervention. Effect on cannulation success rates: There was no difference in the proportion of subjects in whom successful cannulation occurred on the first attempt. CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Davies, E.H., and Molloy, A. (2006). Comparison of ethyl chloride spray with topical anaesthetic in children experiencing venipuncture. Paediatric Nursing, April; 18(3): 39-43. Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis Comparison between ethyl chloride with Ametop (tetracaine). Hypothesis: Ethyl vinyl chloride would not provide equal or better pain levels compared to tetracaine (Ametop), but would still be a viable and effective option. • Cross-over design study; randomizing children to receive either ethyl chloride or tetracaine (Ametop) for their first of three venipunctures. • Second venipuncture on the opposite side of the body. • Third was the child’s choice which provided additional data on acceptability. • Each venipuncture was 2 hours apart. • Ages 5 to 13 years; undergoing glomerular filtration rate measurement. • First venipuncture: Ethyl Chloride n= 38, • Tetracaine (Ametop) n = 39 • Third venipuncture (child’s choice): Ethyl Chloride n= 42, Tetracaine (Ametop) n = 33 • Child’s self-report of pain using the Wong-Baker faces scale at the time of venipuncture. Skin cleansed with alcohol swab; ethyl chloride spray held eight inches from the skin; spray not to exceed ten seconds; no more than 45 second delay between spray and venipuncture; no repeated spraying. Ametop application followed manufactures guidelines of 30 to 45 minutes. Quality of Evidence Level of Evidence Pain scores were higher on the second venipuncture than the first in both groups. Ethyl chloride had a lower pain score than tetracaine (Ametop) on both venipuncture episodes. For the third venipuncture episode, both ethyl chloride and tetracaine (Ametop) scores were lower than in all the previous venipuncture episodes, with ethyl chloride being remarkably lower. Data suggests that younger children under nine years of age preferred tetracaine (Ametop) for their third venipuncture episode (64%). Limitations of this study is that the impact of anxiety levels, distraction techniques, and/or play therapy upon venipuncture pain. I II Effect of vapocoolant spray to placebo on pain due to IV cannulation: Found a modest but significant reduction in pain with the use of vapocoolant spray. Success rate on first cannulation attempt: Cannulation on the first attempt was more often successful with the use of vapocoolant spray than with placebo. I II Findings/Implications Vapocoolant Farion, K.J., Splinter, K.L., Newhook, K., Gaboury, I., Splinter, W.M. (2008). The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. Canadian Medical Association Journal, 179(1); 31-36. Primary outcome measure was the children’s self-reported pain during intravenous cannulation. Secondary outcome measure included the success rate on first attempt and assessments from the children’s parents, nurses and child life specialist. Double blind randomized controlled trial Children age 6 - 12 years who required urgent (within 30 - 45 minutes) IV cannulation. Recorded baseline demographic data, patient self-report of anxiety on a 100 mm color visual analogue scale from “not scared” to “extremely scared”. Recorded presence of CLS, nurse experience, distraction activity. All participants received standard preparation and distraction. Only the data of the first attempt was measured. Vapocoolant sprayed for 4-10 seconds until the skin blanched. Child rated pain immediately following IV cannulation. 16 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis Quality of Evidence Level of Evidence The combination of cold and vibration decreased venipuncture pain significantly more than standard care without compromising procedural success. II II Overall, studies indicate that oral sucrose is an effective, safe, convenient, and immediate-acting analgesic for reducing crying time and significantly decreases bio-behavioral pain response following painful procedures with infants. II I Findings/Implications Vibration/Ice Baxter, A. , Cohen, L., McElvery, H., Lawson, M. & von Baeyer, C. (2011). An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Peds Emergency Care, 1 (12), 1151-1156. Compare a reusable device combing cold and vibration to standard care (vapocoolant or distraction) for pedi venous access pain relief using a prototype of a novel battery-powered device, Buzzy - which combines cold, with vibration, and distraction. Also wanted to evaluate parent-report and observation measures of pain for additional evidence of the effectiveness of the device and to evaluate venipuncture success. Prospective randomized Controlled trial - single center. IRB approved N = 81 Convenience sample of 4-18 y.o. randomized to vibration device or standard care. Setting: freestanding urban/suburban ED with an annual census of 80,000 between April 1 and Aug 15, 2008 Categorical values are presented as the % of frequency with X2 comparisons or Fisher exact test when appropriate. Pacifiers and Sucrose Hatfield, L., Chang, K., Bittle, M, Deluca, J. & Polomano, R. (2011). The analgesic properties of intraoral sucrose. An integrative review. Advances in Neonatal Care, 11(2) 83-92 To evaluate the efficacy and safety of oral sucrose as a pre-procedural intervention for mild to moderate procedural pain in infants. Systematic review of 46 randomized clinical trials examining the utilization of oral sucrose as a pre-procedural intervention for mild to moderate procedural pain in infants were identified from electronic databases: Medline, CINAHL N?A 17 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis Findings/Implications Quality of Evidence Level of Evidence I III Local Application of Ice Movahedi, A.F., Rostami, S., Salsali, M., Keikhaee, B., Moradi, A. (2006). Effect of local refrigeration prior to venipuncture on pain related responses in school age children. Australian Journal of Advanced Nursing, 24(2), 51-55. To evaluate the efficiency of local refrigeration of skin prior to venipuncture as a non-pharmacological and non-invasive intervention to reduce the pain related response to the painful procedure. Hypothesized that application of local refrigeration to the skin would decrease the pain-related responses associated with venipuncture. Physiological responses measured twice pre-procedure. Skin on the area of IV insertion was refrigerated by an ice bag for 3 minutes and the procedure was performed immediately after. The behavioral responses were measured with CHEOPS during the procedure. Five minutes after the procedure the physiological responses, behavioral responses and subjective (self-reported) responses were measured. Design: Quasi-experimental study. N = 80 (40-test group/40-control group) Randomization NO Convience Sample NO Population: 6 - 12 yrs IRB Approval: YES Ahwaz Jondishapour University of Medical Sciences, Ahwaz, Iran Physiological, behavioral, subjective responses. Physiological responses consisted of pulse, respiration and BP. Measured just before the procedure and 5 minutes after the procedure. Behavioral responses measured with CHEOPS. Data recorded during the procedure and 5 minutes after the procedure. Subjective responses – the child was asked about the intensity of pain after the procedure. Utilized the Oucher scale or pictures for those who cannot count. 18 Physiological response before and after the procedure showed no significant difference between the two groups. There was significant difference between the test and control groups in behavioral response. There was significant difference between the test and control groups in subjective response. This study found that local refrigeration is effective for relieving pain associated with venipuncture. It is further noted that more research regarding the effectiveness of this intervention on other age groups is needed. CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis Findings/Implications Local Anesthetic Preparations Lander, J.A., Weltman, B.J., and So, S.S. (2006). EMLA and Amethocaine for reduction of children’s pain associated with needle insertion. Cochrane Database of Systematic Reviews 2006, Issue 3. Art. No.:CD004236. DOI:10.1002/14651858. CD4236.pub2. Compare the topical anesthetics tetracaine (amethocaine) and an eutectic mixture of local anesthetics (EMLA) in terms of anesthetic efficacy, ease of needle insertion and adverse events when used for intravenous cannulation and venipuncture in children. Primary Outcomes: Pain and ease of needle procedure were the primary outcomes. Systematic Review Randomized controlled trials were selected that compared EMLA and tetracaine (amethocaine) for relieving children’s pain from intravenous cannulation or venipuncture. Two review authors independently extracted data and any differences were resolved. 226 unique references were identified; nine references fulfilled the initial review criteria. Six trials consisting of 534 children were included in this review. Children 3 months to 15 years of age were included. While the included trials assessed the occurrence or amount of pain in various ways, all trials assessed and reported the occurrence of no pain. Thus, data was converted to dichotomous values of no pain or pain using information reported in the trials. 19 Tetracaine (Amethocaine) versus EMLA Pain: Amethocaine was compared with EMLA for any dose given for at least the manufacturer’s recommended length of time. The comparison significantly favored amethocaine over EMLA. Self-report Pain Scale Measures: Amethocaine was significantly favored over EMLA. Observational Pain Scales: The difference between the two drugs was not significant suggesting that amethocaine and EMLA were comparably efficacious in preventing pain from an observer’s perspective. Sub-group Analysis: Type of Pain-Inducing Procedure: When intravenous cannulation was the only needle procedure used, the analysis significantly favored amethocaine. Findings: Poor quality of measurements in the included studies and problems with double blinding; assessment of pain behavior as judged by observers; trials used scales that had not been subjected to proper tool development procedures. Implications for Practice: Tetracaine (Amethocaine) outperforms EMLA regardless of whether application time is short, long, or as recommended by the manufacturers. Tetracaine (Amethocaine) is preferred over EMLA for needle insertion procedures on children. Quality of Evidence Level of Evidence CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis Newbury, C. & Herd, D.W. (2009). Amethocaine versus EMLA for successful intravenous cannulation in a children’s emergency department: a randomized controlled study. Emergency Medicine Journal, 26:487-491. Purpose of Study: To determine if amethocaine increases first attempt success rates compared with EMLA , and Whether amethocaine provides superior analgesia to EMLA in a children’s emergency environment. Design: Parallel, randomizes, blinded, controlled study N=65 Randomization: YES Population: Age > 3 months. Approved by the Northern Regional X Ethics Committee. Tampered envelopes were discovered suggesting an attempt at allocation de-concealment. This was addressed and corrected. Visual Analog Scale valid and reliable in children aged 2 months to 7 years. FLACC score has reliability and validity as a measure of pain in children aged 4-19 years. Sethna, N.F., Verghese, S.T., Hannallah, R.S., Solodiuk, J.C., Zurakowski, D., Berde, C.B. (2005). A randomized controlled trial to evaluate S-Caine Patch™ for reducing pain associated with vascular access in children. Anesthesiology, 102(2), 403-408. Purpose of Study: Prospectively investigated the efficacy and tolerability of a novel delivery device. Design: RCT N = 64 patients with a 2 :1 randomization Population: 3-17 years old IRB Approval: YES Setting: Study Center – healthy subjects – not patients. Applied patch for 20 minutes and then removed. Oucher pain scale – has been tested for validity and reliability in children. S-Caine patch or placebo placed for 20 minutes. All participants (investigators, child, parents) were unaware of the identity of the treatment. Evaluated erythema and edema, skin blanching, patient’s skin type and behavior before the vascular access. Reference 20 Quality of Evidence Level of Evidence Primary: The first attempt cannulation success rate for amethocaine was 75.8% compared with 73.9% for EMLA. There is no significant difference between EMLA and amethocaine for success of first attempt IV cannulation. Blanching of the skin with EMLA and the erythema caused by amethocaine did not have a clinically significant effect on the ability to cannulate children. There was no statistically significant difference in the VAS scores or the FLACC scale using both a parametric t test and a non-parametic Wilcoxon test. The behavioral observations showed no statistically significant difference between EMLA and amethocaine in reducing the pain and distress of IV cannulation. II II This study demonstrated that the S-Caine Patch reduced pain significantly compared with the placebo patient within a 20-min application time in children. 59% reported no pain in the S-Caine group compared to 20% in the placebo group. 5% of patients in the S-Caine group reported severe pain vs 20% in the placebo group. Patients who received S-Caine Patch treatment had slightly more erythema and edema than patients who received placebo patch treatment – not statistically significant. Success rate of vein entry and cannulation was 100% in both groups. Transient skin irritation occurred in both groups. I II Findings/Implications CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Singer, A.J., Taira, B.R., Chisena, E.N., Gupta, N., Chipley, J. (2008). Warm lidocaine/tetracaine patch versus placebo before pediatric intravenous cannulation: A randomized controlled trial. Annals of Emergency Medicine, 52(1), 41-47 Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis Research Questions: Compared the pain of IV cannulation in pediatric emergency department patients after applying a topical lidocaine/ tetracaine patch vs placebo. The application of the active patch would reduce the pain of IV cannulation by at least 15 mm. Secondary outcomes: Whether IV cannulation was successful after the first attempt; ease of cannulation; whether the parent though the anesthesia was sufficient; whether the parent would use the patch again for IV cannulation; presence of adverse events; nurses assessment about whether the patient experienced pain during IV cannulation; nurses’ degree of satisfaction with the patch. Design: Randomized, double-blind, placebo-controlled, prospective N = 40 20 in treatment group ; 20 in placebo group. Population: 3 to 17 yrs IRB Approval: YES Academic ED Suburban Lido patch and placebo were identical in appearance. Both contained a small heating element. Both nurses and patients were blinded. 23 G angiocatheter. VAS utilized or Wong Baker Faces if unable to use the VAS. (both scales are validated). Pain assessed immediately after the first cannulation attempt 21 Findings/Implications Application of a topical lidocaine/tetracaine patch resulted in a modest reduction in the pain of IV cannulation in pediatric ED patients and did not alter the rate of successful cannulation. The median pain of IV cannulation in the lidocaine/tetracaine group was significantly lower than in the placebo group. Number of successful IV cannulations after the first attempt was similar in the lidocaine/ tetracaine group and the placebo group. Parents felt adequate pain relief was more common in the lidocaine/tetracaine group. Parents were more likely to state that they would request the use of a similar patch again, though the difference was not significant. The nurse felt that IV cannulation was painless was greater for those subjects in the lidocaine/ tetracaine group. Ease of use was similar in both groups, nurses tended to be more satisfied with the lidocaine/tetracaine patch; difference not significant. Adverse events in both groups small and identical. Quality of Evidence Level of Evidence I II CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Taddio, A., Soin, H.K., Schuh, S., Koren, G., Scolnik, D. (2005). Liposomal lidocaine to improve procedural success rates and reduce procedural pain among children: a randomized controlled trial. CMAJ; 172(13): 1691-1695. Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis To determine whether liposomal lidocaine improves cannulation success rates. To determine whether it reduces pain and procedure duration and is associated with a low frequency of dermal reactions. Primary outcome was successful cannulation on the first attempt. Number of attempts and duration of the procedure was recorded. Double-blind randomized controlled trial. Conducted in the pediatric ED. Children 1 month to 17 years who required peripheral IV cannulation. Liposomal lidocaine n=69. Placebo n=73. 5% liposomal lidocaine in a 5-g tube and placebo (base without active ingredient in a 5-g tube. 1 g of either active or placebo drug applied to two potential sites for 30 minutes under an occlusive dressing. Cream removed after 30 minutes Baseline pain assessment after 25 minutes by parents or by children who were 5 years of age or older using the Faces Pain Scale-Revised (FPS-R). Skin reactions assessed after cream removed. Nurse rated difficulty expected for cannulation. Research assistant rated the child’s pain and obtained pain scores from children 5 years and older and from all parents using the FPS-R. Pain was rated by a research assistant for children less than 5 years; Pain was rated by the child for children 5 years and older; Pain was rated by the parent on all children, 22 Findings/Implications Cannulation Success Rate: Significantly higher among children who received liposomal lidocaine than among those who received placebo (74% vs. 55%). Total Procedure Time: Time required to achieve successful cannulation was shorter among children who received liposomal lidocaine (6.7 minutes vs. 8.5 minutes). Skin Reactions: Same in both groups. In the subset of children who were able to rate their own pain (age > 5 years, n=67) those who received liposomal lidocaine reported less pain than those who received placebo. Limitations: Of the 151 subjects, 9 (6%) were excluded from the primary analysis due to late discovery of ineligibility or withdrawal. Missing data for some pain scores from parents, duration of first cannulation attempt, or duration of total procedure. It is noted that there was a significant age spread among subjects, from 1 month to 17 years. The mean age in the liposomal lidocaine group was 6.7 years and the mean age in the placebo group was 5.1 years. Quality of Evidence Level of Evidence II II CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis Findings/Implications Quality of Evidence Level of Evidence Subdermal Local Anesthetic With Needle-Free Delivery Jimenez, N., Bradford, H., Seidel, K.D., Sousa, N., & Lynn, A,M. (2006). A comparison of a needle-free injection system for local anesthesia versus EMLA for intravenous catheter insertion in the pediatric patient. Anesthesia and Analgesia, 102: 411-414. This study compares the effectiveness of J-Tip versus EMLA to facilitate IV cannulation and provide adequate analgesia before IV placement in children. Simple randomization with a computer random number generator. Children 7-19 years old who required IV placement before elective surgery. EMLA Group n=59 J-Tip Group n=57 Patients were assigned to receive either 2.5 g of EMLA on the dorsum of both hands or 0.25 mL of 1% buffered lidocaine injected with J-Tip for local anesthetic before IV placement. Expected time would exceed 60 minutes, allowing optimal analgesia for the EMLA group. Pain rated at the time of removal of the occlusive dressing in the EMLA group and at the time of lidocaine application in the J-Tip group. Pain rated at time of cannulation. All pain ratings were performed using a VAS from 0 – 10. Person completing the cannulation (anesthesiologist or nurse) recorded the number of attempts for cannulation and ease of the procedure using a dichotomous scale. Ferayorni, A., Yniguez, R., Bryson, M., & Bulloch, B. (2012). Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture. Pediatric Emergency Care, 28(7), 687-690. Compare needle-free jet injection of lidocaine to saline in reducing pain before LP in infants. Prospective randomized Controlled trial - single center. IRB approved N = 55 Infants less than 3 months of age, weight greater than 4 kg. meeting clinical criteria for lumbar puncture Two possible sites for venipuncture were covered by a thick layer of cream and an occlusive dressing. Mean time from application to IV cannulation: EMLA group - 69 minutes. J-Tip group - 1.8 minutes. Pain Rating during IV cannulation: Significant difference between the EMLA group (median, 3) and the J-Tip group (median, 0) NOTE: Because 40% of the patients in the EMLA group had application times less than the recommended 60 minutes, a subset analysis comparing J-Tip subjects with only those EMLA subjects who had application times > 60 minutes. Comparison remained significant in the restricted subset. Pain Score at the Time of Application: Buffered lidocaine with the J-Tip was significantly lower than the EMLA. J-Tip with no pain = 84% EMLA with no pain = 61% Difficulty of Procedure: Reported as easy, the J-Tip = 89%; EMLA = 72% (not statistically significant). Limitations: Application of the EMLA < 60 minutes in some patients, related to variable surgical schedules. (The separate analysis that was conducted considering only patients with EMLA times more than 60 minutes did not show any differences when compared with the analysis performed with the whole group.) Studies primarily a preteen and adolescent group. Study stopped early due to identification of significant findings. I I Categorical values are presented as the % of frequency with X2 comparisons Fisher exact test when appropriate. Infants in the lidocaine group demonstrated significantly shorter cry duration (38.5 versus 48.8 seconds (P = 0.04)) and lower pain scores. 4.1 (1.3) for the lidocaine group and 4.8 (0.5) for the saline group (P = 0.01)). II II 23 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix I: Evidence Table Reference Spanos, S., Booth, R., Koenig, H., Sikes, K., Gracely, E., Kim, I.K. (2008). Jet injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: A randomized controlled trial. Pediatric Emergency Care, 24(8), 511-515. Research/Purpose Questions/Hypothesis Design/Sample Setting Variables/Measures Analysis Findings/Implications To evaluate the use and anesthetic effectiveness of J-Tip needle-free jet injection of 1% buffered lidocaine versus topical ELA-Max before pediatric PIV catheter insertion in the PED. Primary outcome measures were VAS pain scores for the PIV catheter insertion as judged by the patients and the blinded observer. Secondary outcome measures were patient and blinded observer VAS scores for pain of jet injection, patient and blinded observer scores for anxiety of PIV catheter insertion, nursing satisfaction of placing the PIV with jet injection or ELA-Max, nursing difficulty of placing the PIV with jet injection or ELAMax, and success rates of PIV insertion Design: Prospective, block-randomized, controlled clinical trial. N = 77 – 2 not analyzed = 75 Convenience sample Population: 8 – 15 yrs old requiring PIV IRB Approved Tertiary care children’s hospital A difference in the VAS of 10 mm was considered to be clinically and statistically relevant. • No music or television allowed. • Patients assessed their anxiety and pain using the VAS. • Randomized to the ELAMax group received the topical application covered by an occlusive dressing for 30 mins. Patients then asked to document their level of pain, PIV inserted; patients documented their pain following PIV catheter insertion. • Randomized to the J-Tip jet injection documented their level of pain immediately before and after jet injection of 1% buffered lidocaine. After 5 mins, patients documented their level of pain. PIV inserted and patients documented the pain they felt following PIV catheter insertion. • Faces of patients were videotaped during the study and a blinded observer reviewed the tapes and used the VAS to judge pain and anxiety. • Nurse who inserted the PIV completed a Likert scale questionnaire regarding difficulty of PIV insertion and overall satisfaction with the PIV catheter insertion. • No significant difference between the groups for pain at time of enrollment and pain before PIV catheter insertion. • No significant difference between the groups for anxiety of PIV catheter insertion, but note that both groups had clinically significant scores for anxiety of PIV catheter insertion and that the scores were very different from reported pain • Patient –reported pain scores, statistically significant, following PIV catheter insertion shows much less pain in the J-Tip jet injection group than in the ELA-Max group. • The blinded observer’s scores for the pain felt following PIV catheter insertion showed a clinically significant difference of less pain following J-Tip jet injection although not statistically significant. • Nurses who inserted the PIV reported similar scores for the two groups for both ease of insertion and overall satisfaction • Route of lidocaine administration did not affect success with the first attempt PIV insertion. 24 Quality of Evidence Level of Evidence I II CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix II: Other Resources Table Reference Research Purpose Conclusions Atkinson, P., Chesters, A., & Heinz, P. (2009). Pain management and sedation for children in the emergency department. British Medical Journal, 339:b4234. 1074-1079. • How is acute pain best treated in children? • What is the role of non-pharmacological methods of pediatric pain relief? • What is the best initial choice for analgesic drug? • How can procedures be carried out with causing further pain? • Which topical anesthetics are available for cannulation and venipuncture? • What are the topical, local, or regional anesthesia options for wounds and injuries? • Does procedural sedation have a role in painful emergency procedures in children? Abnormal physiology (heart rate, respiratory rate, blood pressure) are poor indicators of pain. Validated scales should be used in children 3 years and older. Involve parents in pain assessment. Parental presence during painful procedure did not decrease pain but did relieve parental anxiety. When presenting with painful conditions children should not wait more than 20 minutes for evaluation and treatment. Children with all levels of pain benefit from acetaminophen (30mg/kg). Nitrous oxide and oxygen mix (for older children) and non-nutritive sucking (young infants) can make minor procedures less distressing. Single dose of oral sucrose is safe and effective in reducing the behavioral and physiological stimulus in preterm infants. Carefully consider the necessity of painful procedures. Ametop superior to EMLA for reducing overall needle insertion pain in children (takes 45 min to work). Ethyl chloride is an alternative for minor procedures but efficacy is unclear. All wounds <5cm should potentially use LAT gel rather than local infiltration. Consider nerve blocks when appropriate. Becker, B.M., Helfrich, S., Baker, E., Lovgren, K., Minugh, P.A., Machan, J.T. (2005). Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation. Academic Emergency Medicine, 12 (4), 289-295. To demonstrate the practical clinical utility and effectiveness of sonophoresis with topical lidocaine for pain control during peripheral IV insertion in adults. The SonoPrep ultrasound device applied to skin for 15 seconds followed by 5 minutes of 4 % liposomal lidocaine cream significantly reduced patient’s perception of IV start pain compared to standard of care with no adverse events. Crandall, M., Kools, S., Miaskowski, C., Savedra, M. (2007). Adolescents' pain experiences following acute blunt traumatic injury: Struggle for internal control. Journal for Specialists in Pediatric Nursing, 12(4), 224-237. Purpose of Study: To examine the subjective experience of adolescent blunt traumatic injury (BTI) pain experiences Adolescents’ behavioral and cognitive actions (“Internal control”) to manage and endure pain were influenced by their pain perceptions, physical losses, and clinicians’ actions. Crellin, D., Sullivan, T.P., Babl, F.E., O'Sullivan, R., Hutchinson, A. (2007). Analysis of the validation of existing behavioral pain and distress scales for use in the procedural setting. Paediatric Anaesthesia, 17(8), 720-733. To determine whether scales frequently used in clinical trials and those recommended in literature have been validated for the assessment of procedural pain in pre-and early-verbal children. VAS scale does not correlate with self-reported pain. TPPPS and PEPPS demonstrate greater validity than VAS however not validated in procedural pain.. CHEOPS and FLACC validated in postoperative pain and used extensively in clinical trials examining procedural pain. However not validated in pre- and early verbal children undergoing painful procedures. Authors cite need for further validation and recommend use of FLACC and CHEOPS scale. Eidelman, A., Weiss, J.M., Lau, J., Carr, D.B. (2005). Topical anesthetics for dermal instrumentation: A systematic review of randomized, controlled trials. Annals of Emergency Medicine, 46(4), 343-351 To compare the analgesic efficacy of topical anesthetics for dermal instrumentation with conventional infiltrated local anesthesia and also to compare topically available amide and ester agents with EMLA cream. Ten RCT compared EMLA with local infiltration of anesthesia. Half of the studies favored EMLA whereas the other half favored local infiltration. Therefore further research is needed. Despite the inconclusiveness EMLA is advantageous b/c it is less painful than local infiltration. Tetracaine, Liposome-encapsulated tetracaine and liposome-encapsulated lidocaine at least as efficacious as EMLA. Liposomal lidocaine offers a more rapid onset than EMLA and is less expensive 25 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix II: Other Resources Table Reference Research Purpose Conclusions Harrison, D.M. (2008). Oral sucrose for pain management in the paediatric emergency department; a review. Australasian Emergency Nursing Journal, 11(2), 72-79. To review sucrose efficacy beyond the neonatal period to enable informed recommendations regarding sucrose use during minor painful procedures in the pediatric population presenting to the ED to be made. Sucrose is effective for minor painful procedures in the post neonatal period. Small volumes of sucrose should be administered 2 min prior to the procedure, immediately upon beginning procedure, and every 2 min during procedure. The addition of a pacifier (if normal care for infant) as well as comfort by child caregiver may give additional comfort and reduce distress. Kuensting, L.L., DeBoer, S., Holleran, R., Shultz, B.L., Steinmann, R.A., Venella, J. (2009). Difficult venous access in children: Taking control. Journal of Emergency Nursing, 35(5), 419-424. To estimate the frequency of difficult venous access in pediatric patients, describe its clinical and emotional impact on patient, family, and clinicians, review factors that help identify risk factors, and discuss management strategies. Risk factors for DVA: Patient related (age <3 years, weight <5kg or <10th percentile, prematurity, obesity, dark or scarred skin, veins that roll, pain, anxiety, fear, needle phobia, emotional/mental status. Physical conditions: Dehydration, sepsis, shock, burns, trauma, edema, and hypothermia. Chronic Conditions: Lists strategies (evidence based) for obtaining access and alternatives to access McGrath, P.J., Walco, G.A., Turk, D.C., Dworkin, R.H., Brown, M.T., Davidson, K., et al. (2008). Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT Recommendations. Journal of Pain, 9(9), 771-783 To identify core domains that should be included in clinical trials of treatment for acute and chronic pain in children. Recommendations for Self Reported Scales to Utilize During Procedures: 3-4 year olds: Poker Chip Tool 4-12 y/o: Faces Pain Scale-Revised 8 y/o and +: Visual Analog Scale Recommendations for Observational Measures for Acute Pain Intensity 1 year + FLACC, CHEOPS, Rauch, D., Dowd, D., Eldridge, D., MacE, S., Schears, G., Yen, K. (2009). Peripheral difficult venous access in children. Clinical Pediatrics, 48(9), 895-901. To estimate the frequency of difficult venous access in pediatric patients, describe its clinical and emotional impact on patient, family, and clinicians, review factors that help identify risk factors, and discuss management strategies. 5 to 33% of children require more than 1 needle stick. Successful placement averages 2.2 sticks per patient and averages 33 minutes. References Difficult Venous Access Tool (points for certain risks) and includes management strategies with a primary focus on alternatives to IV therapy. Wong, DL., Baker, CM. (1988). Pain in children. Comparison of assessment scales. Pediatric Nursing. 14, 9-17. This study is an attempt to provide the basis for selecting suitable research scales for pain assessment. Second objective is the identification of painful events as perceived by hospitalized children. Hypothesis/Theoretical Framework: No difference between the first test and the retest for preference, validity and reliability of the six scales. Preference: Statistically significant. Most preferred for all age groups was the faces scale. Validity and Reliability: Not statistically significant. No significant differences exist among the scales for any age group. Colors chosen for pain ratings were analyzed using a frequency table. No one color scale predominated. Colors often differed in the test and retest. Orange most often associated with least pain and black for most pain. Chi square was significant for least and most pain colors for the overall age group. Children’s favorite color also showed variable relationship to choice of pain colors. Painful events: Trend toward decreasing pain rating with age for procedure pain and increasing pain rating for bodily pain. Most commonly reported painful events were venipuncture for drawing blood, insertion of PIV lines, injections, stomach hurting, leg pain, pain when moved, postoperative pain, head pain and finger sticks. The only procedure consistently reported as painful was arterial puncture. 26 CLINICAL PRACTICE GUIDELINE: Needle-Related Procedural Pain in Pediatric Patients Appendix II: Other Resources Table Reference Research Purpose Conclusions Young, K.D. (2005). Pediatric procedural pain. Annals of Emergency Medicine, 45(2), 160-171. This article reviews the evidence for long-term negative effects of inadequately treated procedural pain, the determinants of an individual’s pain response, tools to assess pain in children, and interventions to reduce procedural pain and distress. Pain defined (International Association for the Study of Pain) as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.” Also states pain is subjective. Infants who have undergone repeated painful procedures in the NICU compared with those who have not react to subsequent procedures with lower behavioral pain responses but higher autonomic cardiovascular responses. Inadequate treatment of a child’s distress at on initial procedure produces a negative ongoing cycle of distress at subsequent procedures. Some pain response determinants are fixed (sex, temperament), some may be modified over time (anxiety, pain coping style), and some may be modified just before or during the procedure (procedure environment, parental interactions, use of nonpharmacologic and pharmacologic interventions). Pain Assessment scales typically assessed by self-report, behavioral reactions, and physiological reactions. Physiological changes are inconsistent and should be used as corroborative data only. Prevention and treatment of procedural pain should be multidimensional, including environmental methods, nonpharmacolgic interventions, and pharmacologic interventions. Creating a culture of a distress-lowering environment requires all team members in the ED. Environmental methods to reduce pain and distress include adequate preparation of the parent and child, a calm nonthreatening environment, anticipation of and planning for each individual child’s expected distress, and training of staff in coping-promoting behaviors. Zempsky, W.T. (2008). Pharmacologic approaches for reducing venous access pain in children. Pediatrics, 122(SUPPL. 3), S140-S153. To review local anesthetic agents used for the management of peripheral venous access in children. Three general methodologies are typically used to bypass the stratum corneum: direct injection of local anesthetics, usually via a small-gauge hypodermic syringe; passive diffusion from topical creams or gels; and active needle-free drug strategies that enhance the rate of drug passage into the dermis and epidermis. Examples of the latter mechanisms include heat-enhanced diffusion, iontophoresis, sonophoresis, laser-assisted transdermal passage, and pressurized gas delivery of powdered drug particles. Pharmacologic options in this setting can also be distinguished on the basis of the time to onset of full anesthetic effect. Several available agents induce significant local anesthesia within 1-3 minutes of administration, or faster, allowing easy integration into the skin preparation and subsequent venous access procedure. In combination with nonpharmacologic approaches, these agents can be used to dramatically lessen this significant source of pediatric pain. Zempsky, W.T., Bean-Lijewski, J., Kauffman, R.E., Koh, J.L., Malviya, S.V., Rose, J.B., Richards, P.T., Gennevois, D.J. (2008). Needle-free powder lidocaine delivery system provides rapid effective analgesia for venipuncture or cannulation pain in children: Randomized, double- blind comparison of venipuncture and venous cannulation pain after fast-onset needle-free powder lidocaine or placebo treatment trial. Pediatrics, 121 (5), 979-987 This study investigates whether a needle-free powder lidocaine delivery system produces effective local analgesia within 1 to 3 minutes for venipuncture and peripheral venous cannulation procedures in children. The needle-free powder lidocaine delivery system was well tolerated and produced significant analgesia compared with placebo within 1 to 3 minute. Zempsky, W.T. (2008). Optimizing the management of peripheral venous access pain in children: Evidence, impact, and implementation. Pediatrics, 122(SUPPL. 3), S121-S124. Supplement Article Gives an introduction to a special journal supplement dedicated to reducing pain in children during peripheral venous access. 27