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You have recently submitted a privilege form to the Fairview System Credentialing Office and requested Moderate and Deep Sedation (sedation/analgesia). Privileges are required in order to perform moderate and deep sedation at any of the Fairview facilities. To complete your request for Moderate and Deep Sedation privileges, the following is necessary: 1. Review the enclosed Physician Self-Learning packet. The criteria for privileges require that you read all the information, complete the case studies and take the quiz at the end of the packet. You must achieve an 80% on the quiz, which you do not need to return. 2. By signing the attestation of the privilege form, you are attesting that you have reviewed the Self-Learning packet and scored at least 80% on the quiz. If you have any questions, please contact the Fairview System Credentialing Office at 612-672-7700. Fairview Health System Sedation/Analgesia Physician Self-Learning Packet Fall, 2002 JoAnn Grimm, CRNA and Marnie Huss, RN Learning Specialists Edited By: Dr Ian Hasinoff Clinical Director of Anesthesia Perioperative Services Fairview University Medical Center Updated policy and m edication grids July / 2006, 2012 2 Sedation/Analgesia Introduction The Joint Commission on Accreditation of Healthcare Organizations (JC) has defined specific standards for the administration of moderate and deep sedation, analgesia and anesthesia. This policy was created to comply with these 2001 Standards, which are based on the American Society of Anesthesiologists (ASA) "Guidelines for Sedation and Analgesia by Non-Anesthesiologists." The standards also state that "individuals administering moderate or deep sedation and anesthesia are qualified and have the appropriate credentials to manage patients at whatever level of sedation or anesthesia is achieved, either intentionally or unintentionally." Privileging physicians to perform moderate/deep sedation meets the intent of "appropriate credentials." The purpose of this Self-Learning Packet is to provide the physician with information necessary to safely and appropriately care for patients receiving moderate to deep sedation/analgesia. This packet is in no way inclusive of all assessments and interventions that might be necessary for an individual patient. Practitioners involved with the care of patients receiving sedation are responsible for understanding and following this policy. 3 Sedation/Analgesia Self-Learning Packet Objectives After completion of this self-learning packet, the physician will be able to: • • • • • • • Define the levels of sedation/analgesia Discuss the indications, contraindications, actions, administration, dosage, potential side effects related to sedatives, analgesics, and antagonists Describe the patient assessments before, during, and after sedation/analgesia. State the advantages and limitations of pulse oximetry Describe the interventions for deepening sedation Identify the appropriate equipment for patient care areas where sedation/analgesia are administered Discuss the Fairview System policy “Sedation and Analgesia for Procedures” This packet contains the system policy, appendices, and attachments referred to in the policy. Additional information to further define levels of sedation, appropriate assessments, interventions, and documentation is also included. Questions and case studies are provided to assess assimilation of information. 4 Sedation/Analgesia Self-Learning Packet Contents The sedation continuum…………………………………………………………………….…..6 Pharmacological recommendations……………………………………………………….…8 Non-pharmacological interventions……………………………………………………….…9 Patient assessment and monitoring………………………………………………………...10 Interventions for deepening levels of sedation/analgesia……………………….….14 “Sedation and Analgesia for Procedures” Policy………………………………………..17 Physical Status Classification of the ASA…………………………………………………..21 Mallampati Classification………………………………………………………………………...22 Modified Aldrete Score…………………………………………………………………………...23 Guidelines for Safe Discharge after Ambulatory Surgery…………………………….24 Sedation Analgesia Recommended Elements of Documentation………………….25 Commonly Used Medications…………………………………………………………………..27 Documentation Form……………………………………………………………………………. 35 Self Study Quiz....………………………………………………………………………………….37 Case Studies Sedation/Analgesia Questions 5 The Sedation Continuum Sedation/analgesia is the practice of producing a calming or sedating effect and/or analgesia through the use of medications. There is no clear delineation among the levels of sedation. JC Standards emphasize that the patient's sedation level is not determined by the drug dose but by the patient's responses to the medication(s). A drug dose producing minimal sedation for one patient may be deep sedation, or, although rare, general anesthesia in another. This requires astute assessment of the patient at all times while the patient is receiving sedative/analgesic medications or recovering from them. The following graphic illustrates the sedation continuum: >>>>>>>>>>>>>>>>>>>>>>>>>>> <<<<<<<<<<<<<<<<<<<<<<<<<<< Minimal (Anxiolysis) Moderate (Conscious Sedation) Deep Anesthesia 6 SEDATION CONTINUUM GRID The Sedation Continuum Grid defines typical signs and symptoms for each level. Minimal Sedation (Anxiolysis) Cognitive function may be impaired Moderate Sedation/Analgesia (Conscious Sedation) Depression of consciousness, easily arousable Normal response to verbal commands Responds purposefully to verbal commands, may require light tactile stimulation Protective Reflexes (Laryngealcough, pharyngealgag) Airway Maintained Maintained Able to maintain patent airway Able to maintain patent airway Spontaneous Ventilation Adequate Cardiovascular Function Maintained Responsiveness Deep Sedation/ Analgesia Anesthesia Depression of consciousness, cannot be easily aroused Loss of consciousness Responds purposefully following repeated or painful stimulation Partial/Complete loss of protective reflexes Not arousable even with painful stimulation Loss of protective reflexes Adequate May require assistance to maintain patent airway May be impaired Often requires assistance to maintain patent airway Often impaired Maintained Maintained May be impaired If the intent is deep sedation, protective reflexes, the ability to maintain an airway, and ventilation may be impaired. 7 Pharmacological Recommendations Sedatives, benzodiazepines, and opioids used for sedation/analgesia may cause somnolence, confusion, diminished protective reflexes (e.g. cough, swallow and gag), airway obstruction, and depressed respiratory and cardiovascular functions. Opioids may also cause nausea and vomiting. Since the level of sedation may easily change from light to deep, continuous monitoring of respiratory and cardiac function is essential. Knowledge of the medications used in sedation/analgesia and reversal agents is the responsibility of the practitioner ordering the administration of each agent as well as the practitioner who performs the actual administration and assessment of patients receiving these agents. Recommendations for medication administration include: • • • • • • • • • Administer medications slowly. Administer medications in incremental doses. Assess/reassess the patient after each dose. Consider that individual patient response to a particular dose of medication may vary significantly. The cardiovascular and respiratory depressive effects of opioids and sedatives are potentiated when used in combination. Drug dosages may need to be decreased based on the patient’s medical condition: e.g. age; cardiac, pulmonary, hepatic and renal function. Drug dosages may need to be increased based on the patient’s current tolerance to opioids and sedatives. The amount of stimulation the patient receives may influence the level of sedation/analgesia observed: e.g. during the actual procedure the patient may be awake and alert. During the recovery period when the stimulation is gone the patient may slip into a deeper level on the sedation continuum. Additional resources available to obtain further information on commonly used sedation/analgesia medications include pharmacists, Medline, and medication reference books. 8 Non-Pharmacological Interventions The ways clinicians interact with patients also helps to reduce their anxiety prior to and during a procedure. Non-pharmacological methods to help reduce the patient's anxiety include: Adequate pre-procedure preparation. Knowledge of what is going to happen during the procedure (sounds, sensations etc.) reduces patient's fear of the unknown. Explanations about the actions of the medications to be used and what the patient may experience after the drugs are administered reduce anxiety. Identification and use of past comfort measures provides additional support. For example, some patients may prefer to talk, some may prefer to be quiet, or some may want help with visualization. • Emotional support. Empathize with the patient: talk with the patient not just at them. Allow and encourage the patient to talk. • Professionalism. A calm, unhurried professional atmosphere comforts patients. Unprofessional, social talk amongst care providers is not beneficial to patients and could increase their stress. • Supportive environment. Control extraneous noise and traffic. Choose music of the patient’s preference, not the staff's. • 9 Patient Assessment and Monitoring Refer to the policy for required assessment and monitoring parameters pre, intra, and post-procedure. A thorough baseline (pre-procedure) assessment provides a reference point, which allow care providers to recognize changes in the patient’s condition. Early detection of undesirable patient responses allows for rapid intervention and treatment. Undesirable effects of sedation/analgesia include: • • • • • • • • Loss of consciousness Hypotension Agitation Combativeness Hypoventilation/decreased oxygen saturation Respiratory depression Airway obstruction Apnea Age 1-6 months 6-12 months 1-2 yr 2-4 yr 4-6 yr 6-8 yr 10-12 yr > 14 yr Age-Specific Normal Vital Signs Weight (Kg) Respiratory Rate Heart Rate 4-6 24-30 120 6-10 24-30 130 10-12 20-24 130 12-14 20-24 120 16-18 20-24 100 20-26 12-20 100 30-45 12-20 75 >50 10-14 70 BP (sys) mm Hg 80 +/- 10 89 +/- 29 96 +/- 30 99 +/- 25 99 +/- 20 105 +/- 13 112 +/- 19 120 +/- 20 Changes in pulmonary and cardiovascular findings may indicate deepening levels of sedation/analgesia, which require increasing monitoring and assessment. 10 Pulmonary Assessment Early recognition of signs and symptoms of inadequate ventilation prevents the patient from becoming hypoxemic or hypercarbic. Signs of a change in the patient’s general status indicate a need for reassessment of the patient's respiratory status. Assessments that may indicate a difficult airway are: • • • • • • • Inability to open the mouth Poor cervical spine mobility Receding chin Large tongue Prominent incisors Short muscular neck Morbid obesity Proceed with caution if the patient has any of these findings: it may be difficult to maintain or reestablish an airway. Signs and symptoms of airway obstruction or inadequate ventilation • • • • • • • • • • • • • Snoring Stridor Nasal flaring Tracheal or thoracic retractions Decreased or absent breath sounds Decreased oxygen saturation Loss of chest expansion Rocking of chest and abdomen Change in mental status: restless, combative, decreased level of consciousness Change in skin color: pale or dusky Change in rate and depth of respirations Change in heart rate and/or blood pressure: may either increase or decrease Apnea 11 Principles of Pulse Oximetry include: • • • • • • Noninvasive method of measuring the oxygen saturation of arterial blood based on absorption of light at a specific wavelength by red blood cells Measures ratio of oxygenated blood to the total amount of oxygen and expresses it as a percentage Heralds a hypoxic event before clinical signs Requires pulsating vascular bed SpO2 >90% = paO2 >60 mm Hg (with normal oxyhemoglobin curve) SpO2 <90% indicative of hypoxemia Advantages Simplicity Noninvasive Continuous display Sensitivity to changes in blood oxygen levels Ability to be applied to all ages Relatively low expense Limitations-Pulse oximeter may not provide accurate reading when there is: Motion at sensor site Interference from ambient or extrinsic light sources Low perfusion states (hypotension, cold extremeties) Significant dysrhythmias Carbon Monoxide or Methemoglobin in blood Severe anemia (Hgb <5 gm/dl) Electrical Interference Suggestions for obtaining an accurate pulse oximeter reading: • • • • • Pick a warm well-perfused finger Be sure the probe fits securely, but not too tight Be sure the finger is clean Be sure the patient’s heart rate matches the oximeter heart rate. If the oximeter is not picking up accurately, try another finger, the ear, or the patient's nose. Plethysmographic waveform monitoring may be helpful to validate a good signal. i.e. pulse wave monitoring Suggestions for troubleshooting the pulse oximeter: • • • • When an alarm sounds-CHECK THE PATIENT If the patient is in trouble-forget the oximeter and TREAT THE PATIENT If the patient is ok-check the oximeter Patient’s heart rate and oximeter rate should be the same rate/rhythm. If the oximeter’s heart rate differs from the patient’s actual heart rate, the pulse oximeter may not be picking up the correct arterial pulse. The oxygen saturation reading may not be accurate. 12 Cardiovascular Assessment Recognition of patients at a higher risk for developing cardiovascular complications as a result of their sedation is an important assessment for care providers to make. Patients with known cardiovascular disease, hypertension, dehydration, and elderly patients are at higher risk for developing hypotension. Monitor blood pressure frequently in these patients. Correlate changes in the patient’s heart rate on the pulse oximeter with the patient’s radial or apical pulse. If the heart rate and/or rhythm change, EKG monitoring should be initiated. Signs and symptoms of inadequate tissue perfusion include: • • • • • • • Decreased blood pressure Increased/decreased heart rate and/or arrhythmias Cool and/or mottled, pale or dusky extremities Changes in mental status: confusion, light headedness, agitation, combativeness, decreased LOC Inability to obtain a pulse oximetry reading Decreased capillary refill Decreased urine output (if monitoring) The frequency of assessments, monitoring, and documentation should be increased if a patient exhibits an undesirable change in their physical assessment or level of sedation/analgesia. 13 Interventions for Deepening Levels of Sedation/Analgesia Patients may occasionally slip into a deeper level of sedation than had been originally intended. If this occurs it is crucial for the care providers to intervene immediately. Follow the ABCDs of basic emergency intervention: Airway, Breathing, Circulation, Defibrillation/Drugs. Do not hesitate to call a code if more help is needed. • Airway: Maintain head in neutral midline position with the neck extended. Perform the head-tilt, chin lift or jaw thrust procedures as needed to relieve airway obstruction. The Head-tilt, chin lift maneuver is performed by lifting the chin with the fingertips underneath the bone at the center of the chin. Add the head tilt if necessary. Tilt the head by placing a hand on the patient’s forehead and tilting the head back so the chin comes up. The Jaw thrust is performed by placing fingers under the angles of the mandible and lifting the jaw forward. (These procedures should be practiced as part of BLS training.) Nasal and oral airways may also be utilized to maintain an open airway. A nasal airway supports upper airway patency in a patient with minimal to moderate obstruction and is well tolerated by awake or sedated patients with an intact gag reflex. The proper nasal airway size may be estimated by the distance from the nares to the angle of the mandible. Nasal airways can cause epistaxis and are usually avoided with patients who are receiving anticoagulation therapy. An oral airway maintains upper airway patency in patients who have airway obstruction from the tongue and soft palate but may not be well tolerated if the patient’s gag reflex is intact. Complications from the use of oral airways include vomiting, laryngospasm, and dental trauma. The wrong size of oral airway may worsen the obstruction. The correct size of the oral airway may be estimated by holding the airway against the patient’s face; the tip of the airway should end just cephalad to the angle of the mandible. If the airway is too short, it may compress the tongue; if it is too long, it may lie against the epiglottis. 14 • Breathing Support the patient's respiratory efforts with bag/valve/mask if the patient’s respiratory rate and depth are inadequate to maintain ventilation. With a respiratory rate less than 8 the patient may need to be manually stimulated or reversed with naloxone according to hospital policy. • Circulation Fluids, patient positioning (legs up or trendelenburg), drugs, and/or CPR may be indicated for inadequate cardiac output (circulation) and tissue perfusion. • Drugs Medications may be indicated either for reversal of sedation/analgesia or for supportive measures, i.e. to support circulation. Reversal agents, naloxone (Narcan®) and flumazenil (Romazicon), and other emergency medications found on the crash cart, should be immediately available. Diminished reflexes, depressed respiratory function, and impaired cardiovascular function may occur with drugs used for moderate and deep sedation. Refer to appropriate medication references. Differential Diagnosis: Once the patient is stabilized the underlying cause of the symptoms and/or event must be sought: e.g. If a diabetic patient is confused - is the cause due to the medications given or to a low blood glucose? Emergency Equipment: Size appropriate emergency equipment listed in the policy, and according to individual patient need, must be immediately available when moderate or deep sedation are preformed 15 Fairview Health Services “Sedation and Analgesia for Procedures” Policy This policy is available on line through the Fairview Intranet Policies and Procedures homepage. Policy update 3/06 16 System Policy Code: S:PC-2012 Entity: Fairview Health Services Manual: Policy and Procedure Category: Subject: Provision of Care, Treatment and Services Sedation and Analgesia for Procedures Purpose: To ensure safe, consistent patient care when procedure-related sedation and analgesia is indicated. Definitions: Minimal sedation (anxiolysis): A drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected. Moderate sedation/analgesia (“conscious sedation”): A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Deep sedation/analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. Anesthesia: Consists of general anesthesia and major regional anesthesia. It does not include local anesthesia. General anesthesia is a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. Mallampati classification: (See Attachment 2) Required airway assessment competency listed in the best practice for moderate sedation by the University HealthSystem Consortium. An airway assessment is to be included in the pre-sedation assessment. Modified Aldrete Score: (See Attachment 3) A suggested method for measuring and documenting recovery from sedation. Exclusions: This policy does not apply to the following patients: 1. Patients receiving low dose sedative and/or analgesic medications for the treatment of pain, anxiety, or sleep disruption common to hospitalized patients. 2. Patients on chronic doses of sedation or antihistamines for existing conditions. 3. Patients receiving minimal sedation for diagnostic and therapeutic procedures where respiratory and cardiovascular functions are not affected. They are able 17 4. 5. Policy: to respond normally to verbal commands even though cognitive function and coordination may be affected. (e.g. minimally invasive procedures such as echocardiograms or voiding cystourethrograms). As such, they will not be allowed to drive, but are excluded from the other requirements of the policy. Patients receiving mechanical ventilation through an artificial airway or patients receiving sedation either intermittently or continuously in an intensive care setting as part of routine care. Patients receiving chronic analgesia or anxiolysis for neoplastic or other conditions that require periodic escalation of therapy for pain relief or anxiety. 1. Patients who have received any sedation, narcotic analgesics, or antihistamines for procedures are not allowed to drive home. 2. Outpatients are to have responsible adult or family member to accompany them at discharge and drive them home. A service providing medically trained drivers or attendants would be acceptable. A cab service would not be acceptable. 3. Prescribing providers must be privileged for the appropriate level of sedation/analgesia. Board-certified physicians in emergency medicine, critical care medicine, neonatology, and oral maxillofacial surgery are considered, by their certification, to be competent and therefore, not required to consult anesthesia care provider as indicated below. 4. Any time deep sedation and analgesia or anesthesia is anticipated appropriately privileged practitioners must be in attendance. The practioner must be able to intubate and rescue those patients who show need for intubation and/or rescue. 5. A consultation with an anesthesia care provider is recommended for a patient who: a. Has known respiratory compromise or hemodynamic instability i. Presents with significant comorbid conditions or sleep apnea. ii. Has an ASA physical status of 4 d. Is assessed to have a Mallampati classification of III (see Attachment 2) 6. A consultation with an anesthesia care provider is required for: a. Patients with an ASA physical status of 5 b. Infants who are born prematurely (<37 weeks gestation) who at the time of the procedure are <60 weeks postconception and who are not residing in the neonatal intensive care unit or pediatric intensive care unit (Note: postconceptual age is the gestational age at birth plus the age since birth [e.g., a baby born at 32 weeks who is 12 weeks old is 44 weeks postconception.]) c. Patients with a history of airway problems during sedation/analgesia or general anesthesia d. Patients with a history of adverse reaction to sedation/analgesia or general anesthesia e. Children with neuromuscular disease affecting respiratory or brain stem function f. Patients who are assessed to have a Mallampati classification of Class IV (see Attachment 2) 7. Sedation and analgesia can be performed in any location where competent personnel and the required equipment are available. 8. Sufficient numbers of personnel (in addition to the licensed independent practitioner performing the procedure) with demonstrated competency must be present to: a. Appropriately evaluate the patient prior to beginning moderate or deep sedation (RN/MD) b. Provide the moderate or deep sedation (RN/MD) c. Monitor and assess the patient (RN) d. Assist with performing the procedure e. Recover and discharge the patient either from the post-sedation area or from the patient care area according to pre-established discharge criteria. (RN) 9. RN staff administering sedation will have: a. No other concurrent responsibilities during the procedure. 18 b. Current BLS certification c. Basic ability to recognize a cardiac dysrhythmia for monitoring purposes d. Working knowledge of sedatives/analgesics and antagonists e. Completed education for sedation and analgesia f. Completed additional education and competency verification to assist physician with deep sedation g. Ongoing education in care of pediatric patients as appropriate 10. Age and size-appropriate equipment for care and resuscitation is available for monitoring vital signs, including heart and respiratory rates, blood pressure, and oxygenation. Equipment includes: 11. a. Blood pressure cuff b. Audible pulse oximetry equipment c. Readily available crash cart (minimally includes ventilation management equipment, O2, suction equipment and emergency medications) d. Cardiac monitor when indicated Recommended medications are: a. Fentanyl (short-acting opioid) b. Midazolam (short acting benzodiazepine) c. Other agents that are approved by the System Formulary Committee in consultation with anesthesia and in consideration of the areas in which they are used (see also medication grid). 12. The patient’s response to care provided throughout the sedationsupported procedure is documented in the patient’s record. Procedure: 1. Outpatients are instructed to have responsible adult or family member to accompany them at discharge and drive them home. Should a patient arrive for a procedure without a responsible adult, the patient should be given the option of not receiving any medication or rescheduling the procedure (may need to consult with the performing LIP as to appropriateness of not receiving medication and the performance of the procedure). 2. Patients are instructed regarding NPO status. (See entity-specific guidelines.) 3. Care for all patients with planned moderate or deep sedation /analgesia includes: a. Pre-sedation assessment to include: • History and physical with focused airway exam (to include auscultation of the heart and lungs and airway evaluation) • Assignment of ASA status • Assessment of sleep apnea b. Formulation of a sedation plan c. Informed consent d. Reassessment immediately prior to sedation e. Assessment on admission to and discharge from post sedation area. 4. Monitoring During Procedure a. Continuously (prolonged without any interruptions at any time) monitored heart rate and oxygenation by audible pulse oximetry b. Respiratory frequency and adequacy of pulmonary ventilation are continually (repeated regularly and frequently in steady, rapid succession) monitored. c. Vital sign and patient assessment every 5-15 minutes as 19 condition warrants (minimally heart rate, respiratory rate, O2 saturation, blood pressure and if indicated, heart rhythm). Vital signs should be monitored after each medication administration and with any significant event. d. Assessment of pain & sedation level with vital signs e. EKG is monitored in patients with significant cardiovascular disease or when dysrhythmias are anticipated or detected. 5. Post-procedure a. For deep sedation, continuously monitored heart rate and oxygenation by audible pulse oximetry. Respiratory rate, blood pressure, and if indicated, heart rhythm monitored minimally every 15 minutes. . (See also Attachment 3, the Modified Aldrete score, for guidance in assessment of recovery status.) b. For moderate sedation, monitoring minimally every 30 minutes. c. Minimum recovery time-one hour post medication or meets established discharge criteria for patient care area. d. Minimum of 2 hours post procedure observation and monitoring if patient has received a reversal agent. 6. Discharge a. Follow pre-established discharge criteria. (See also Attachment 4, the “Guidelines for Safe Discharge After Ambulatory Surgery”, for guidance in assessment of recovery status.) b. A responsible adult must accompany outpatients. Patients who have received any sedation, narcotic analgesics, or antihistamines for procedures cannot drive themselves home. It is recommended that the responsible adult remain with the patient for 6 hours. If the patient is unable to have a responsible adult stay with them after the procedure, additional recovery time may be considered before discharge. c. Patients are discharged by a qualified Licensed Independent Practioner or according to criteria approved by the medical staff. 7. Documentation a. Documentation forms may vary. b. Documentation to include: • The recommended elements (see attached.) • Use of a sedation scale to quantify level of sedation during and after the procedure. • Use of a pain scale to quantify level of pain during and after the procedure. • Name and/or signature of person responsible for patient at the time of discharge. 8. Adverse outcomes of patients undergoing sedation/analgesia are collected, analyzed, and addressed according to entity procedures. 20 External Ref: “Moderate Sedation Best Practice Recommendations”, University Health System Consortium, 2005 Internal Ref: Entity-Specific Attachments: • FLHS: FLHS Addendum, Medication Grid, Audit Tool, Consent Form, Ambulatory Discharge, Decision-Making Checklist, Minimum Sedation Guidelines, NPO Guidelines, Sedation Record • FSH: Medication Grid • UMMC Medication Grid Source: System-wide Sedation and Analgesia Committee Approved by: Policy Committee Date Effective: 9/02 Date Revised: 3/06 Date Reviewed: 3/06 Attachment 1 ASA Physical Classification System P1 P2 P3 P4 P5 P6 A normal healthy patient A patient with mild systemic disease A patient with severe systemic disease A patient with severe systemic disease that is a constant threat to life A moribund patient who is not expected to survive without the operation A declared brain-dead patient whose organs are being removed for donor purposes. (http://www.asahq.org/clinical/physicalstatus.htm; March 9, 2006) 21 Attachment 2 Mallampati Classification The Mallampati classification is based on the finding that visualization of the glottis is impaired when the base of the tongue is disproportionately large. Assessment is made with the patient sitting upright, with head in neutral position, the mouth open as wide as possible, and the tongue protruded maximally. The modified classification includes four categories: Class I Faucial pillars, soft palate, and uvula are visible. Class II Faucial pillars and soft palate may be seen, but uvula is masked by the base of the tongue. Class III Only soft palate is visible. Intubation is predicted to be difficult. Class IV Soft palate not visible. Intubation predicted to be difficult. 22 Attachment 3 The Modified Aldrete Score Activity Able to move four extremities voluntarily or on command Able to move two extremities voluntarily or on command Unable to move extremities voluntarily or on command Respiratory Able to breathe deeply and cough freely Dyspnea or limited breathing Apneic Circulation BP + 20% of preanesthetic level BP + 20-49% of preanesthetic level BP + 50% of preanesthetic level Consciousness Fully awake Arousable on calling Not responsive O2 Saturation Able to maintain O2 saturation >92% on room air Needs O2 to maintain O2 saturation >90% O2 saturation <90% even with O2 supplement Total Score 2 1 0 2 1 0 2 1 0 2 1 0 2 1 0 Patients with scores of 8-10 may be transferred to the next phase of recovery. Aldrete, J. Antonio: Modifications to the Postanesthesia Score for Use in Ambulatory Surgery. Journal of PeriAnesthesia Nursing, Vol 13, No 3 (June), 1998: pp 148-155 23 Attachment 4 Guidelines for Safe Discharge After Ambulatory Surgery Score Activity Able to move four extremities voluntarily or on command Able to move two extremities voluntarily or on command Unable to move extremities voluntarily or on command Respiratory Able to breathe deeply and cough freely Dyspnea or limited breathing Apneic Circulation BP + 20% of preanesthetic level BP + 20-49% of preanesthetic level BP + 50% of preanesthetic level Consciousness Fully awake Arousable on calling Not responsive O2 Saturation Able to maintain O2 saturation >92% on room air Needs O2 to maintain O2 saturation >90% O2 saturation <90% even with O2 supplement Dressing 2 1 0 2 1 0 2 1 0 2 1 0 2 1 0 Dry and clean Wet but marked and not increasing Growing area of wetness 2 1 0 Pain free Mild pain handled by oral medication Severe pain requiring parenteral medication 2 1 0 Able to stand and walk straight* Vertigo when erect Dizziness when supine 2 1 0 Able to drink fluids Nauseated Nauseated and vomiting 2 1 0 Has voided Unable to void but comfortable Unable to void and uncomfortable 2 1 0 Pain Ambulation Fasting-Feeding Urine output Total *May be substituted by Romberg’s test, or by picking up 12 clips in one hand. A score of 18 or higher is required for home discharge. Aldrete, J. Antonio: Modifications to the Postanesthesia Score for Use in Ambulatory Surgery. Journal of PeriAnesthesia Nursing, Vol 13, No 3 (June), 1998: pp 148-155 24 Attachment 5 Sedation Analgesia Recommended Elements of Documentation RN Pre-Sedation Assessment • Vital signs: Temp/Pulse/Resp, BP, O2 saturation • Height/weight • NPO status • Pain level • Level of consciousness • Health history including: • Medications/allergies • Screens for nutrition, function, communicable/infectious disease, domestic abuse • Females: Pregnant/nursing • Labs (as indicated) • Diagnostic tests (as indicated) • Venous access device • ID band • Allergy band (as indicated) • Physician assessment (history/physical) • Affirmation of Informed Consent • Outpatients: Responsible adult • Patient teaching • • • • • • MD Pre-Sedation Assessment History/physical including: • Review of past medical history • Review of anesthesia/sedation history • Assessment for sleep apnea • Medications/allergies • Physical exam: Heart/lungs/airway Vital signs review Labs (as indicated) review Diagnostic tests (as indicated) review Informed consent for sedation ASA assignment 25 • Sedation plan • Reassessment immediately prior to procedure • • • • • • • Intra-Procedure Vital signs: Temp/Pulse/Resp, BP, O2 saturation Sedation level Pain level Supplemental O2 (as indicated) Medications VAD/IV fluids Adverse outcomes • • • • • • • Post-Procedure Vital signs: Temp/Pulse/Resp, BP, O2 saturation Sedation level Pain level Admission and discharge criteria scores Discharge teaching/instructions (as indicated) Outpatients: Responsible adult Adverse outcomes Miscellaneous • Names/titles of staff • Pertinent procedure-specific information 26 PRE-SEDATION AGENTS Drug Atropine Route IV, IM, PO, PR, SQ Dose/Titration <5kg: IV, IM, PO, PR, SQ 0.1 mg Note this is based on 0.02 mg/kg/dose with a minimum of 0.1mg/dose in this population. ANTISECRETORY AGENTS Onset Duration PO, IM: 15 4 hours minutes – 1 hour Side Effects/Precautions Use with caution in patients with tachycardia, thyrotoxicosis, obstructive diseases of the GI tract, obstructive uropathy, spastic paralysis, myasthenia gravis, and cystic fibrosis. Monitor heart rate since atropine may cause tachycardia. IV: 10 minutes Pregnancy Category C No definite association with malformations, possible drug class association. Has been used to decrease secretions before c-sections. May cause decreased respiratory rate in fetus. The AAP considers atropine compatible with breastfeeding, although the extent to which it passes in to breast milk is unknown. 5-50 kg: IV, IM, PO, PR, SQ 0.01-0.02 mg/kg/dose Minimum dose 0.1mg Maximum dose 0.5mg Adult Dose or patient > 50kg: 0.4 mg SQ, IM, or IV Maximum dose 1mg Glycopyrrolate IV, IM <5kg: IV, IM: 0.05 mg Note this is based on 0.01 mg/kg/dose with a minimum of 0.05mg/dose in this population. IV: 1-10 minutes Up to 7 hours IM: 15-30 minutes Monitor heart hate: may cause tachycardia. Use with caution in patients with tachycardia, thyrotoxicosis, obstructive diseases of the GI tract, obstructive uropathy, spastic paralysis, cystic fibrosis, hepatitis, and myasthenia gravis. Pregnancy Category B Crosses placenta, but less than atropine. Possible drug class association with minor malformations. Has been used to decrease secretions before c-sections. Anticholinergic of choice for anesthesia for electroconvulsive therapy in pregnant patients. No breastfeeding data available. 5-50 kg: IV, IM: 0.005-0.01 mg/kg/dose Minimum Dose: 0.05 mg Maximum Dose: 0.25mg Adult Dose or patient > 50kg: 0.1-0.3mg IM/IV Maximum dose 0.5mg LOCAL AGENT Drug 1% Lidocaine Route Infiltration Dose/Titration 3-5 mg/kg/dose via infiltration (not parenterally) Onset 45-90 seconds Duration 1-2 hours Maximum dose in combination with epinephrine: 7 mg/kg Side Effects/Precautions Doses may vary based on procedure, degree of anesthesia needed, tissue vascularity and duration of effect required. Consider degree of dosage in patients with impaired liver function. Pregnancy Category C Rapidly crosses placenta. No evidence of association with large categories of major or minor malformations. Has been used for epidural anesthesia during labor. Possible complications for infant include: decreased muscle strength/tone, CNS depression, seizures, apnea. Treatment of choice for ventricular arrhythmias during pregnancy. TOPICAL AGENT Drug 4% Lidocaine (LMX-4 or EMLA) Route Topical Dose/Titration Children weighing <10 kg: Apply topically to an area not larger than 100 cm (typically half of a 5gm tube) Children weighing 10-20 kg: Apply topically to an area not larger than 200 cm (typically a 5gm tube) Onset 30 minutes Duration 1-2 hours after removal of cream Side Effects/Precautions Apply to intact skin. Covering with an occlusive dressing is optional Lidocaine is Pregnancy Category C Note: The above dosages are only intended to be used only as guidelines. Depending upon patient, slightly higher or lower doses may be necessary. Last Update: February, 2006, Fairview Pharmacy Services Agents for Adult Sedation Drug Midazolam Drug Fentanyl Benzodiazepine – For Sedation, Amnesia, and Relief of Anxiety Only. Not for Pain Control Dose/Titration Onset Duration Side Effects/Precautions IV: Duration after single Adults < 65 yrs old Adverse Drug Reactions: 1-2 mg IV over 1 minute; wait 2 minutes 1-5 min dose = 20-40 minutes 1. CNS effects/withdrawal to evaluate response; if needed, give 1 (IV) 2. Respiratory depression, apnea mg IV slowly every 4 minutes until 3. Anterograde amnesia Elimination = desired response (usually not more than 5 4. Hiccups, nausea, vomiting metabolized by the mg needed) 5. Rarely hypotension liver, excreted in urine and feces Not removed by hemodialysis or peritoneal dialysis Adults >/= 65 yrs old 0.5-1.5 mg IV over 1 minute; wait 2 Active metabolite = minutes to evaluate response; titrate in Pregnancy category D Yes 0.5 mg increments every 4 minutes to Freely crosses placenta, although more slowly than lorazepam and diazepam. Possible complications for newborn: desired response (up to a maximum of hypotonia, lethargy, sucking difficulties, IUGR, withdrawal symptoms. Half-life = 1-12 hrs 3.5 mg) Excreted in breast milk. Mean Milk: Plasma ration 0.15 (longer with chronic dosing) Unknown effect on breastfeeding infant-prolonged exposure not recommended Narcotic – For Pain Control Only. Not Appropriate for Sedation, Amnesia, or Relief of Anxiety Dose/Titration Onset Duration Side Effects/Precautions IV: 30-60 minutes Adverse Drug Reactions: Adults < 65 yrs old 25-50 mcg IV over 2-3 minutes (may 3 minutes 1. Respiratory depression, apnea repeat every 5-10 minutes to a maximum Elimination= hepatic 2. Bradycardia, hypotension dose of 200 mcg in 60 minutes) 3. Nausea and vomiting Half-life=2-7 hours 4. Sedation 5. Decreased gut mobility Adults >/= 65 yrs old 25-50 mcg IV over 2-3 minutes (may 6. Urinary retention repeat every 5-10 minutes to a maximum dose of 100 mcg) Hypotension with rapid administration The respiratory depressant effect of fentanyl may last longer that the analgesic effect May have synergistic effect when used with Versed®; consider lower doses when used in this combination Consider the total dose of all narcotics used Pregnancy Category B (Category D if used in high doses for prolonged periods at term). Freely crosses placenta. No reports of congenital defects. Possible effects on newborn include withdrawal and respiratory depression Excreted in breast milk. AAP considers morphine compatible with breastfeeding Narcotic Reversal Agent Drug Naloxone Dose/Titration Take contents of one 0.4 mg/ml ampule (use filter needle) and dilute with 9ml of normal saline to a total volume of 10ml. This will provide a concentration of 0.04mg/ml. Give 1ml (0.04mg) IV q1-2 minutes until desired degree of reversal is obtained. May need to repeat dose every 20-30 minutes, or more frequently. Observe for re-sedation, return of respiratory depression. For narcotic overdose where rapid and full reversal is necessary, the entire contents of the 0.4 mg/ml ampule may be given IV (undiluted) – repeat as necessary to obtain necessary response. Onset IV: 2-3 minutes Duration Duration after single dose = 1-2 hours Elimination = conjugated in the liver, eliminated in the urine Side Effects/Precautions May precipitate withdrawal symptoms (e.g. hypertension, sweating, agitation, nausea, and irritability) in patients dependent on opiates. Use with caution in these patients, and in those with chronic cardiac and pulmonary diseases. Naloxone effects may wear off before the effects of the narcotic do, and sedation and respiratory depression may reoccur. Active metabolite = No Adverse Drug Reactions: Excessive reversal, withdrawal symptoms, agitation Drug Interactions: May reverse hypotensive and bradycardic effects in clonidine overdose Half-life= 30-80 min The duration of action of the opioids may exceed that of Naloxone, so REPEATED DOSES may be necessary Pregnancy Category B Freely crosses placenta. Has been safely given to infants immediately after delivery. No information on safety of use during pregnancy. No breastfeeding data available. AGENTS FOR ADULT SEDATION Benzodiazephe Reversal Agent Drug Dose/Titration 0.2mg IV over 15 seconds If the desired level of consciousness is not obtained after waiting an additional 45 seconds, may repeat with 0.2mg at 60second intervals, up to a maximum total dose of 1mg. Flumazenil Onset IV: 10-120 seconds Peak Response= 6-10 minutes Duration Duration after single dose = 60-90 minutes Elimination = eliminated by hepatic metabolism Side Effects/Precautions Do not use in patients with a tricyclic antidepressant overdose. Seizures may occur in patients who are physically dependent on benzodiazepines or are receiving them for control of seizures. Flumazenil effects may wear off before the effects of the benzodiazepine do, and sedation may reoccur. May not reliably reverse respiratory depression. Adverse Drug Reactions: Seizures (see above), arrhythmias (rare), nausea and vomiting. Active metabolite = May accumulate in hepatic impairment. In the case of re-sedation, repeated doses No may be administered at 20-minute Pregnancy Category C intervals as needed. For repeat treatment, Half-life= 45-80 min No breastfeeding data available. no more than 1 mg (given as 0.2mg/min) should be administered at any one time, and no more that 3 mg should be given in any one hour. Note: The above dosages are only intended to be used only as guidelines. Depending upon patient, slightly higher or lower doses may be necessary. References: 1. 2. 3. 4. 5. An updated report by the American Society of Anesthesiologists Task Force on sedation and analgesia by non-anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002:96:1004-1017. Guidelines for conscious sedation and monitoring during gastrointestinal endoscopy. Gastrointestinal endoscopy 2003:58:317-22 PengP, Sandler AN. A review of the use of fentanyl analgesia in the management of acute pain in adults. Anesthesiology 1999:90:576-99 Bahn EL, Holt KR. Procedural sedation and analgesia: a review and new concepts. Emerg Med Clin N Am 2005;23:503-17 Horn E, Nesbit SA. Pharmacology and pharmacokinetics of sedatives and analgesics. Gastrointest Endoscopy Clin N Am 2004;14:247-68 Last Updated: February 2006, Fairview Pharmacy Services Drug Fetanyl (Various brands) Route IV Drug Naloxone (Narcan) Route IV Medications for Pediatric Sedation Narcotics- For pain control only. Not appropriate for sedation, amnesia, or relief of anxiety. Dose/Titration Onset Duration Side Effects/Precautions Neonates: 1-2 mcg/kg/dose, may repeat at 3-5 1 – 3 minutes IV: <60 minutes Respiratory depression, apnea, hypotension, bradycardia, dizziness, nausea. minute intervals until effect, then every 30-60 Rapid infusion may result in chest wall rigidity, give over 3-5 minutes minutes Decrease dosages in hepatic and renal insufficiency and elderly, debilitated patients. T1/2 = 2-4 hours Infant (18-36 months): 1-2 mcg/kg/dose, may Pregnancy Category B (D if prolonged use or high doses) repeat at 3-5 minute intervals until effect, then Freely crosses placenta. No reports linking fentanyl to congenital defects. every 30-60 minutes Possible complications for newborn: withdrawal, respiratory symptoms Children <12 years old: 1-2mcg/kg/dose, may repeat in 30-60 minutes Excreted in breast milk. AAP considers morphine compatible with breastfeeding. >12 yrs: 0.5-1 mcg/kg/dose, up to 50mcg/dose May repeat in 30-60 minutes Dose/Titration To provide a gradual / titratable reversal: Take contents of one 0.4mg/ml ampule; using a filter needle, dilute with 9ml of normal saline to a final volume of 10ml Narcotic Reversal Agent Onset Duration 1-2 minutes 1-3 hours T ½ = 1.5 hours Side Effects/Precautions Pulmonary edema, nausea, sweating, tachycardia, irritability May precipitate withdrawal. Contraindicated in patients with chronic narcotic usage. Avoid use in neonates born to mothers with narcotic or cocaine addiction <20kg; <5 yrs Give 0.25ml (0.01mg) IV; repeat every 1-2 minutes as needed to achieve desired reversal 20kg; >5yrs Give 1ml (0.04mg) IV; repeat every 1-2 minutes as needed to achieve desired reversal Use with caution in cardiac disease or chronic pulmonary disease Caution: Reversal of narcotic effect may wear off before the effects of the narcotic; redosing may be necessary For full reversal: Give 0.2mg/kg IV (max dose of 2mg); may be repeated q2min, as required Benzodiazepines- For sedation, amnesia, and relief of anxiety only. Not for pain control. Drug Route IV/IM Midazolam (Versed) Dose/Titration Neonates: 0.05-0.2 mg/kg/dose Q 1-4 hrs Onset PO: 20-30 minutes Duration PO: 2-6 hours IV: 20-30 minutes Side Effects/Precautions Respiratory depression, hypotension, bradycardia, hiccups, apnea. Decrease dosages in hepatic and renal insufficiency. IV: 1-5 minutes PO and Rectal IV IV <12 years: 0.25-0.5 mg/kg PO 30-45 min before procedure May repeat 0.25mg/kg/dose PO x 1. Max PO dose = 1mg/kg up to a total of 20mg T1/2 = 1-4 hours May cause paradoxical excitement. Monitor RR, HR, BP, O2 saturation Pregnancy Category D: freely crosses placenta. Possible complications for newborn: hypotonia, lethargy, sucking difficulties, IUGR, withdrawal 0.05-0.1mg/kg IV 3 minutes before procedure Titrate to a maximum of 0.4-0.6mg/kg IV Excreted in breast milk. Milk:plasma ratio = 0.15 Unknown effect on breastfeeding infant >12 years: 0.5mg IV every 3-4 minutes to a total dose of 2.5-5mg. A total dose >5mg is generally not needed. Benzodiazepine Reversal Agent Drug Flumazenil (Romazicon) Route IV Dose/Titration Children: 0.01 mg/kg (MAXIMUM 0.2mg/dose) IV over 15 seconds; may repeat 0.01mg/kg (0.2mg MAXIMUM) every minute to MAXIMUM TOTAL CUMULATIVE DOSE of 0.05mg/kg or 1mg, whichever is less Onset IV: 1 – 3 minutes Duration 45-90 minutes Side Effects/Precautions Hypoventilation, may precipitate seizure. T1/2 = 30-90 minutes Pregnancy Category C No breastfeeding data available. 30 Drug Chloral Hydrate Drug Pentobarbital Drug Thiopental Rectal Route PO or Rectal Route PO, IM, PR, IV Route Rectal Dose/Titration Neonates: 30-50 mg/kg PO or rectal, 30-60 minutes prior to procedure; only single dose Infant (18-36 months): 50-75 mg/kg PO or rectal, 30-60 minutes prior to procedure. May repeat 25mg/kg/dose x 1 dose. Max dose for infants is 100mg/kg up to 1 gram per day Children (1-12 years old): 25-75 mg/kg x 1 dose. May repeat 25mg/kg x 1 dose. (max 2 grams / day) Dose/Titration >6 months-4 years: PO, IM, PR: 2-4 mg/kg to max of 100 mg. IV: 1-2 mg/kg, then 1-2 mg/kg q5-10 min >4 years – adolescents: PO, PR: 1.5-3 mg/kg to max of 100 mg. IM: 2-6 mg/kg to max of 100 mg. IV: 1-2 mg/kg, then 1-2 mg/kg q5-10 min. Maximum total dose: 6 mg/kg Adolescents: PO, IV: 100 mg prior to procedure. Maximum total dose: 500 mg Dose/Titration PR: 10-20 mg/kg Onset 10-20 minutes Other Agents Duration 4-8 hours Onset IV: 1 minute PO, IM, PR: 30-60 minutes Side Effects/Precautions Use with caution in porphyria. Possible side effects: respiratory depression, increase in bilirubin, paradoxical excitement. T1/2 = 4-12 hours Pregnancy Category C. No reports linking chloral hydrate to fetal abnormalities. Sedative effects in fetus not studied. Excreted in breast milk. AAP considers chloral hydrate compatible with breastfeeding. Risk of drowsiness or sedation for breastfeeding infant. Duration 1-4 hours Side Effects/Precautions Rapid IV injection may cause respiratory depression, apnea, laryngospasm, bronchospasm, and hypotension. Administer dose over 10-30 minutes Do not inject at a rate > 50 mg/min. Monitor respiratory, cardiovascular and CNS status Pregnancy Category D. No data suggesting association with major malformations. Hemorrhagic disease and barbiturate withdrawal in the newborn are theoretic possibilities. Significant toxicity on neural development and sexual function has been noted with Phenobarbital. Excreted in breast milk. Effect on the infant is unknown. Onset 10-15 minutes Duration 60-120 minutes Side Effects/Precautions Contraindicated in porphyria and status asthmatics. May cause paradoxical excitement. Since drugs cannot be titrated by the rectal route, monitor closely for over sedation --monitor RR, HR, and BP. Pregnancy Category B. Safety during pregnancy has not been determined. No breastfeeding data available. The AAP and WHO considers thiopental usually compatible with breastfeeding. Drug Methohexital Rectal Route Rectal Dose/Titration PR: 10-20 mg/kg Onset 10-15 minutes Duration 60 minutes Side Effects/Precautions Contraindicated in porphyria and temporal lobe epilepsy. May cause paradoxical excitement. Since drugs cannot be titrated by the rectal route, monitor closely for over sedation ---monitor RR, HR, and BP Pregnancy Category B. Safety during pregnancy not determined. No breastfeeding data available. The AAP considers Methohexital compatible with breastfeeding. The Thomson Lactation Rating states that infant risk cannot be ruled out.. Last Update: February 2006, Fairview Pharmacy Services References: 1. Cravero JP and Blike GT, Review of pediatric sedation. Anesth Analg 2004;99:1355. 2. Flood RG and Krauss B. Procedural sedation and analgesia for children in the emergency department. Emerg Med Clin North Am 2003; 21:121 3. Kaplan RF and Young CI. Sedation and analgesia in pediatric patients for procedures outside the operating room. Anesthesiol Clin North Am 2002;20:181. 4. Krauss B and Green S. Sedation and Analgesia for procedures in children. N Engl J Med 2000;342:938 5. Rodriguez E and Jordan R. Contemporary trends in pediatric sedation and analgesia. Emerg Med Clin North Am 2002;20:199 6. Tolia V, Peters JM, Gilger MA. Sedation for pediatric endoscopic procedures. J Pediatr Gastroenterol Nutr 2000;30:47. 31 ANESTHETIC AGENTS FOR SEDATION NOTE: MEDICATIONS WHICH MAY BE USED ONLY IN THE INTENSIVE CARE UNITS OR IN THE ED AND ORAL SURGERY CLINIC - BY PRIVILEDGED AND CREDENTIALED ANESTHESIOLOGISTS, INTENSIVISTS, ED PHYSICIANS, ORAL SURGEONS OR THE ANESTHESIA SERVICE. COMBINATIONS OF DRUGS MAY ALSO POTENTIATE THE RISK OF APNEA AND AIRWAY OBSTRUCTION; THEIR USE SHOULD ALSO BE RESTRICTED TO THE ABOVE LOACTIONS.) ULTRA SHORT ACTING / ANESTHETIC Drug Route Dose/Titration Onset Duration Side Effects/Precautions IV 20 seconds 4-10 minutes Comments: Use cautiously in patients, <10 yrs of age, may induce seizures and Etomidate Pediatric Sedation: IV: 0.1-0.2 mg/kg epileptiform activity, therefore etomidate should be used with caution in epileptic (Amidate) Peak effect: 1 min patients. Transient myoclonic movements unrelated to seizure activity is frequently seen. Pediatric Induction for RSI: IV: 0.2-0.4 mg/kg Safer to use with poor cardiac function. Pregnancy Category C. Animal and human studies have shown no teratogenicity with the use of Etomidate. None detected in breast milk 4 hours after use. Adult Sedation: IV: 0.05-0.1 mg/kg Adult Induction for RSI: IV: 0.2-0.4 mg/kg *Use lower doses for sedation, higher doses will result in general anesthesia. Drug Ketamine (Ketalar) Route PO, PR, IV Dose/Titration Pediatric Sedation: PO and Rectal: 4-8 mg/kg 30 minutes prior to procedure. IV: 0.05-1 mg/kg over 2-3 min Supplemental doses: ½ of initial dose IM: 2-4 mg/kg; may use with Atropine 0.01-0.02 mg/kg, midazolam 0.05-0.1 mg/kg Pediatric Induction for RSI: IM: 5-10 mg/kg IV: 1-2 mg/kg SEDATIVE, GENERAL ANESTHETIC Onset Duration Side Effects/Precautions PO: 30-45 minutes PO: 10-30 minutes IV: Do not exceed 0.5 mg/kg/min. (conc. <2mg/ml) Monitor cardiovascular effects, HR, BP, RR and O2 saturation. IM & PR: 5-15 IM 10-30 minutes May cause apnea, laryngospasm, respiratory depression, tachycardia, hypertension and minutes increased salivation. Contraindicated in the presence of head injury because it may cause increased ICP and intraocular pressure. Dysphoric reactions not uncommon, upon IV: 1 minute IV 5-15 minutes emergence. Treat with benzodiazepines. Pregnancy Category B. No report of malformations in humans. Possible complications (dose-related) included: maternal hypertension, increased muscle tone, newborn apnea/respiratory depression, depressed neonatal neurobehavioral. Undetectable amounts in breast milk 11 hours after use. Adult Sedation: IV: 0.25 – 1 mg/kg (not recommended PO/PR for adults) Adult Induction for RSI: IV: 1-2 mg/kg Contraindicated <3 months. *Low dose Ketamine may be used for pain management outside of this protocol. Drug Propofol (Diprivan) (*NOTE: See Propofol Policy for additional information) Route IV Dose/Titration Pediatric: IV: Load: 0.5- 1 mg/kg; titrate as needed Infusion: 25-100 mcg/kg/minute Induction for RSI: 1-2 mg/kg IV *Use lower doses for sedation, higher doses (100300 mcg/kg/min) result in general anesthesia Adults: IV: Load: Moderate Sedation 0.25-0.5 mg/kg Induction for RSI: 1-2 mg/kg IV Titrate as needed Infusion: 25-100 mcg/kg/min Onset 30 seconds Peak Effect: 2 minutes Duration 3-10 minutes Side Effects/Precautions Continuous monitoring and airway management required. Apnea and airway obstruction occur at high doses. May cause dose related hypotension. Not recommended for patients with increased ICP or impaired cerebral circulation unless the patient is intubated with assisted ventilation. Not recommended for patients with poor cardiac function. Monitor RR, BP, HR, O2 saturation, and ABG’s. Pregnancy Category B. Safety during pregnancy has not been determined. No breastfeeding data available. Contraindicated in soy or egg allergies. ANESTHETIC AGENTS FOR SEDATION ANESTHETIC ADJUNCTS, SHORT ACTING BARBITURATES Drug Thiopental (Pentothal) Route IV Dose/Titration Pediatric Sedation: IV: 0.5-1 mg/kg Total recommended dose infused slowly over 35 minutes. Pediatric Induction for RSI: IV: 2-8 mg/kg Onset 30 seconds Duration 5-10 minutes Side Effects/Precautions Contraindicated in porphyria and status asthmatics. Monitor RR, HR, & BP Apnea and airway obstruction may occur. Hypovolemic patients are at risk for hypotension. Pregnancy Category C. Rapid placental transfer. Prolonged exposure could result in accumulation in the fetus with possible teratogenic effects. No breastfeeding data available. Adult Sedation: IV:0.5- 1 mg/kg slowly over 3-5 min Adult Induction for RSI: IV: 2-8 mg/kg IV, divided in 2-4 doses Drug Methohexita (Brevital) Route IV Dose/Titration Adult Sedation: IV :0.25-0.5 mg/kg Adult Induction for RSI: IV: 0.5-1 mg/kg Onset 30 seconds Duration 5-10 minutes Side Effects/Precautions Contraindicated in porphyria Side Effects: Rare severe allergic reactions, allergic skin reactions, histamine release, hypotension, twitching, shivering, tremors, hiccups (11%), cough, respiratory depression Pediatric Sedation: Rectal route advised, due to pain of IM injections. IV not recommended Rectal dose:10-20 mg/kg Pediatric Induction for RSI: Rectal Dose: 25mg/kg Note: The above dosages are only intended to be used only as guidelines. Depending upon patient, slightly higher or lower doses may be necessary. **NOTE: Do not use the “DTP” cocktail (Demerol, Phenergan, and Thorazine). Its use has been associated with seizures, dystonia, respiratory depression and even death. Last Update March, 2006, Fairview Pharmacy Services 33 Sedation Grid –Age Adjusted Dosing of Medications References 1. 2. 3. Horn E, Nesbit SA. Pharmacology and pharmacokinetics of sedatives and analgesics. Gastrointest Endoscopy Clin N Am 2004;14:247-268. Tsui BCH, Wagner A, Finucane B. Regional anesthesia and the elderly. Drugs Aging 2004;21:895-910. Fick DM, Cooper JW, Wade WE, Waller JL, Maclean R, Beers MH. Updating the beer’s criteria for potentially inappropriate medication use in older adults. Arch Intern Med 2003;163:2716-2724. 34 SEDATION/ANALGESIA FOR DIAGNOSTIC & THERAPEUTIC PROCEDURES DOCUMENTATION FORMS PHYSICIAN RESPONSIBILITIES Prescribing providers must be privileged for the appropriate level of sedation/analgesia. • • • • Pre-Sedation Assessment: Complete “Pre-Procedure Physical Assessment” section of the form Obtain patient informed consent Document “Classification of Physical Status ASA Score” Assess patient immediately prior to sedation/procedure and sign, date and time form (required documentation) Intra-Procedure • Perform the procedure, direct the administration of the sedation/analgesia. Post Procedure/Discharge • Complete post-procedure note and orders. Sign Post-Procedure section of the form, date and time form To meet regulatory requirements all sections of the documentation forms must be filled out. On the outpatient procedures form (four-page form), the credentialed/privileged clinician must complete the bottom of page 2. On the inpatient procedures form (two-page form) this section is located on the bottom of page 1. All clinicians must adhere to Safety Protocol for Invasive and/or High Risk Procedures (Site Marking and Verification) Policy Code: S:PC-2013 and document appropriately. Conclusion The objectives of sedation and analgesia are: • Mood alteration. • Comfortable and cooperative. • Decreased pain. • Elevation of the patient's pain threshold with minimal changes in vital signs. • Partial amnesia. • Prompt and safe return to activities of daily living. Knowledge of the principles of sedation is crucial to delivering safe care to the patients who will benefit from these medications and techniques. It is imperative that care provider’s administering or monitoring sedation/analgesia understand and adhere to the policy governing the use of this practice within the Fairview System. 36 Test Your Knowledge! 37 Case Studies The following scenarios were created to enhance critical thinking in situations that may be encountered. Think about how you would react in each situation and then review the discussion points on the following page. 1. The end of the procedure is near and you have been monitoring your patient closely. The patient has received 2 mg of Versed pre-procedure and 100 mcg of Fentanyl intra-procedure. The patient’s vital signs have been stable. He has been drowsy and requires tactile stimulation in order to respond appropriately to verbal commands. His pulse oximeter readings have been between 94 and 98% on room air. What concerns do you have for the patient? 2. A 150 kg, somewhat anxious, gentleman is being admitted for a procedure. His orders read “3 mg Versed pre-procedure IV”. The patient has a history of sleep apnea. How do you prepare for this patient’s care? 3. An elderly 45 kg woman, with increased liver enzymes, is scheduled for a procedure this a.m.. You decide to use Versed® and Fentanyl. What precautions do you take with this patient? 4. A diabetic patient is admitted for a renal biopsy. During the procedure the patient seems a little confused. The pulse oximeter reading is 90%, her heart rate is slightly increased, and her blood pressure is slightly decreased from pre-procedure. The preprocedure pulse oximeter reading was 99%. How should you advise the monitoring clinician? 5. During a procedure, you are advised that the patient’s respiratory rate has decreased to 8. The pulse oximeter is reading 96%. 38 Discussion Points for Case Studies 1. This patient is at risk to slip into a deeper level of sedation/analgesia in the postprocedure period when the stimulation of the procedure is over. 2. Talk with the patient about the procedure and explain what might be felt and heard. Dose the medication to effect. Because of the sleep apnea and obesity this patient is more prone to airway obstruction and apnea-decreased ventilation. A nasal airway may be appropriate for this patient should complications develop. Due to this patient's size a larger dose of medication may be required to achieve the desired level of sedation/analgesia. 3. Due to this patient's age, weight, and liver function a smaller doses of medications may be required. Give medications slowly and dose to effect. Versed and Fentanyl potentiate each other’s effects. 4. Check this patient’s: A: Airway-assure patency and intervene as needed. B: Breathing-rate and rhythm- initiate O2. C: Circulation-correlate patients heart rate with the pulse oximetry monitor for accuracy of saturation reading. D: Drugs-assure that resuscitation medications are available. D: Differential Diagnosis-confirm source of confusion (low glucose or hypoxemia/hypercarbia.) Monitoring: increase frequency of assessments and documentation until patient returns to baseline. 5. This patient may need tactile stimulation to maintain or increase ventilations. You may need to assist the patient with bag-valve mask ventilation . Additional doses of sedative medications should not be given. Consider reversal if unable to maintain ventilation. Constant monitoring of respiratory function into the post-procedure period is crucial. 39 Sedation/Analgesia Questions 1. The RN designated to monitor/assess a patient during a procedure utilizing sedation/analgesia may assist the physician performing the procedure as needed. T F 2. Transport of sedated patients must be done by providers who are able to monitor, assess and intervene if needed. T F 3. Patients who have met discharge criteria must have a responsible companion to escort and drive them home. T F 4. Documentation during a procedure must occur a) Every 5 to 15 minutes as conditions warrant b) After administration of every medication c) With any significant event d) All of the above 5. Size appropriate equipment and supplies must be immediately available. T F 6. Which of the following medications reverses the effects of Benzodiazepines. a) Narcan (Naloxone) b) Romazicon (Flumazenil) 7. Which of the following medications reverses the effects of Narcotics. a) Narcan (Naloxone) b) Romazicon (Flumazenil) 8. Dosage adjustments may be needed for a) Elderly b) Impaired renal function c) Hepatic insufficiency d) All patients depending on their response to the medication 9. The effects of reversal agents may wear off before the effect of the sedative or analgesic. T F 40 10. A patient received 3 mg of Versed IV 10 minutes ago. In what level of sedation will this patient be? a) Minimal b) Moderate c) Deep d) Unable to determine 11. A patient who is moderately sedated may need assistance to maintain a patent airway. T F 12. A patient who is deeply sedated will follow a simple command to open his eyes. T F 13. Of the following, which are signs of inadequate airway/ventilation? a) Snoring b) Change in LOC c) Loss of chest expansion d) Nasal Flaring e) All of the above 14. All of the following describe moderate sedation except: a) Allows protective reflexes to be maintained b) A medically controlled state of depressed consciousness or unconsciousness from which the patient is not easily aroused and is unable to respond purposefully to physical stimulation or verbal command c) Retains the patient’s ability to maintain a patent airway independently and continuously d) Permits appropriate response by the patient to physical stimulation or verbal command (e.g: open your eyes”) e) The drugs, doses and techniques are not intended to produce a loss of consciousness 15. A 55-year-old woman has a history of adult onset diabetes mellitus. She also has a history of hypertension. Both diseases are controlled by diet alone. She is scheduled for a colonoscopy. This patient is an ASA Physical Classification of: a) ASA I b) ASA II c) ASA III d) ASA IV e) ASA V 16. Prior to performing a procedure with sedation/analgesia the physician must perform or provide the following: a) A brief medical history and physical exam b) A signed consent form c) An ASA Patient Classification Status d) Verify the patient’s NPO status e) All of the above 41 17. An excellent indicator of adequate moderate sedation is: a) Unconsciousness b) Bradycardia c) Slurred Speech d) Unresponsiveness e) A normal blood pressure and heart rate 18. Monitoring parameters include: a) Heart rate, blood pressure, respirations b) Heart rate, blood pressure, and oxygen saturation c) Heart rate & rhythm, blood pressure, respirations, oxygen saturation and level of consciousness d) Heart rate & rhythm, blood pressure, oxygen saturation and respirations e) Heart rate, blood pressure, respirations, and oxygen saturation 19. The RN monitoring the patient receiving sedation/analgesia: a) May be the Charge Nurse b) May also circulate in the room and get equipment from the hallway c) May not be engaged in any other activity during this period d) May not apply oxygen if needed e) Should do the preoperative history and physical prior to the procedure 20. Naloxone (Narcan) can be used to reverse all of the following except: a) Midazolam b) Merperidine c) Fentanyl d) Morphine e) Sublimaze 21. Your patient had respiratory depression. You have given 150 mcg of Fentanyl. The patient will not respond to verbal stimulation. You should give Flumazenil to reverse the effects of the narcotic: a) True b) False 22. What information is not needed in the history for a patient undergoing a procedure using sedation/analgesia: a) Allergies b) Past experiences with anesthetic drugs c) Pregnancy or menstrual history d) Last meal e) All of the above are necessary in the history 42 23. Prior to discharge the nurse must have all of the following except: a) Written instructions from the physician for the patient b) Name and telephone number of a responsible adult to accompany the patient c) Number of the ride arranged with public transportation and address they are to take the patient to d) Complete documentation of the entire procedure including the recovery period e) Assured the patient’s ability to void and retain oral fluids 24. All of a) b) c) d) e) the following are considered clear liquids except: Plain coffee or tea Breast milk Grape juice Apple juice Water 25. It is prudent to wait 6 hours prior to performing sedation/analgesia on a patient who has had Cream of Tomato soup within the last hour: a) True b) False 43 Answers to Sedation/Analgesia Questions 1. F 2. T 3. T 4. D 5. T 6. B 7. A 8. D 9. T 10. D 11. F 12. F 13. E 14. B 15. B 16. E 17. C 18. C 19. C 20. A 21. B 22. E 23. C 24. B 25. A 44