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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?
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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
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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.
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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
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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,
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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.
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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.
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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).
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CLINICAL PRACTICE GUIDELINE:
Needle-Related Procedural Pain in Pediatric Patients
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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
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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