Procedural Sedation S. Greg Escue, MD 8/28/2008

Outline Introduction Definition Preparation Summary of key points Patient Assessment Personnel Equipment Monitoring Medications Summary of key points

ACEP Clinical Policy Level A recommendations Level B recommendations Generally accepted principles for patient management that reflect a high degree of clinical certainty (ie, based on strength of evidence Class I or overwhelming evidence from strength of evidence Class II studies that directly address all the issues) Level B recommendations Recommendations for patient management that may identify a particular strategy or range of management strategies that reflect moderate clinical certainty (ie, based on strength of evidence Class II studies that directly address the issue, decision analysis that directly addresses the issue, or strong consensus of strength of evidence Class III studies).

ACEP Clinical Policy Level C recommendations Other strategies for patient management based on preliminary, inconclusive, or conflicting evidence, or in the absence of any published literature, based on panel consensus Strength of evidence Class I Interventional studies including clinical trials, observational studies including prospective cohort studies, aggregate studies including meta-analyses of randomized clinical trials only.

ACEP Clinical Policy Strength of evidence Class II Observational studies including retrospective cohort studies, case-controlled studies, aggregate studies including other meta-analyses. Strength of evidence Class III Descriptive cross-sectional studies, observational reports including case series and case reports, consensus studies including published panel consensus by acknowledged groups of experts

ACEP Clinical Policy Total of 16 Recommendations Only 1 Level A Recommendation Total of 4 Level B Recommendations Total of 11 Level C Recommendations

Definition A technique of administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function. A suppressed level of consciousness that is adequate to allow the administration of painful or unpleasant diagnostic or therapeutic maneuvers in a way that minimizes patient awareness, discomfort, and memory, while attempting to preserve spontaneous respiration and airway-protective reflexes.

Definition Key point – Sedation is a Continuum Moderate sedation previously referred to as ‘‘conscious sedation’’ defined as a drug-induced depression of consciousness during which patients respond purposefully. Deep sedation drug induced depression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated or painful stimulation. These patients may require assistance in maintaining airway patency and ventilatory effort

Definition – Things to Remember Procedural Sedation is a Continuum Proper administration of sedative medications is a continuum Individual response to medications is often difficult to predict possess the skills required to rescue a patient 1 level greater than the intended level of sedation Some suggest a separate category for dissociative agents

Preparation Proper personnel Monitoring Monitoring Respiratory Status Patient Assessment Fasting Status Proper personnel Proper Equipment Monitoring Monitoring Respiratory Status Medication(s)

Patient Assessment Lack of outcome-based studies Obtain a history and perform a physical examination to identify features that may affect procedural sedation and analgesia and airway management Medical illnesses Medications and allergies Anatomic features No routine diagnostic testing is required before procedural sedation. (Level C recommendations)

Fasting Status The combination of vomiting and loss of airway protective reflexes is an extremely rare occurrence with procedural sedation and analgesia, making aspiration an unlikely event no uniformly accepted practice standards Formal Recommendation (Level C) Recent food intake is not a contraindication for administering procedural sedation and analgesia, but should be considered in choosing the timing and target level of sedation.

Proper Personnel Physician/staff knowledgeable in Effects of the medication Monitoring the patient’s response to medication Managing complications If physician involved in performing a procedure Support personnel capable of monitoring patient No clear evidence on the number of personnel necessary to safely provide procedural sedation and analgesia

Proper Personnel Formal Recommendation (Level C) Procedural sedation and analgesia in the ED must be supervised by an emergency physician or other appropriately trained and credentialed specialist. During moderate and deep sedation, a qualified support person should be present for continuous monitoring of the patient.

Proper Equipment Although rare, procedural sedation and analgesia may result in an allergic reaction, respiratory arrest, or cardiopulmonary arrest. Oxygen Suction Medications (naloxone, flumazenil, ACLS) Advanced life support equipment (eg, a bag-mask ventilation device, and intubation equipment) IV access (possible exception – Ketamine IM)

Equipment Formal Recommendations (Level C) Oxygen, suction, reversal agents, and advanced life support medications and equipment should be available when procedural sedation and analgesia is used. Intravenous access should be maintained when intravenous procedural sedation and analgesia is provided. Intravenous access may not be necessary when procedural sedation and analgesia is provided by other routes.

Monitoring Vital signs Ability to respond to verbal stimuli BP, Pulse, Respiratory Rate, Pulse Oximetry Ability to respond to verbal stimuli Should be documented before, during, after Medication and amount used Remember, over 90% of adverse events occur during the procedure Median time – 2 mins after last med dose

Preparation Monitoring Formal Recommendation (Level C) Obtain and document vital signs before, during, and after procedural sedation and analgesia. Monitor the patient’s appearance and ability to respond to verbal stimuli during and after procedural sedation and analgesia.

Monitoring Respiratory Status Pulse Oximetry Good correlation with PaO2 Does not correlate with hypoventilation Desaturation can be delayed by supplemental oxygen in the face of hypoventilation Capnometry May be able to detect hypoventilation before desaturation No evidence of impact on patient outcome If used, look for >50 or change of >10 from baseline

Monitoring Respiratory Status Level B Recommendation Pulse oximetry should be used in patients at increased risk of developing hypoxemia, such as when high doses of drugs or multiple drugs are used, or when treating patients with significant comorbidity Level C Recommendations When the patient’s level of consciousness is minimally depressed and verbal communication can be continually monitored, pulse oximetry may not be necessary. Consider capnometry to provide additional information regarding early identification of hypoventilation

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Medications Ideal Agent Provides both ANALGESIA and AMNESIA Rapid onset Short duration Rapid recovery Titrate Medication dose to desired effect (Level B Recommendation) Fast administration increases risk of hypotension or respiratory depression If using both a benzodiazepine and an opioid, it is suggested the opioid should be given first and the benzodiazepine dose titrated

Medications Use of drugs in combination may accentuate the potential side effects associated with each drug individually In 1 study, use of versed alone resulted in no significant respiratory depression Use of fentanyl alone caused hypoxemia in 50% and caused a decrease in ventilatory response to carbon dioxide, but did not cause apnea When versed and fentanyl were used together, hypoxemia occurred in 92% of subjects, and apnea occurred in 50%.

Medications Ketamine Causes dissociative state in which a patient may not speak or respond purposefully to verbal commands Use of ketamine in the doses recommended for procedural sedation and analgesia does not result in a loss of protective reflexes In a consecutive case series of 1,022 children, Green et al report that ketamine at doses of 4 to 5 mg/kg intramuscularly produced adequate sedation in 98% of children.

Medications Ketamine Airway complications occurred in 1.4% of patients including laryngospasm, apnea, and respiratory depression, all of which were quickly identified and treated without intubation or sequelae. Emesis occurred in 6.7% without evidence of aspiration. Formal Recommendation Level A - Ketamine can be safely administered to children for procedural sedation and analgesia in the ED

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More on Ketamine Ketamine IV or IM? 4mg/kg IM (max 200mg) vs 1mg/kg IV (max 100mg) Both given with glycopyrrolate 5mcg/kg max dose 250mcg Other studies suggest 1.5mg/kg IV more appropriate loading dose 27% IV pt’s required multiple dosing Only 9% IM pt’s 8.3% IV pt’s desaturated Only 4% IM pt’s desaturated

More on Ketamine More IM pt’s vomited (35% vs 20%) IM Pt’s reported less pain Effective Dissociation longer in IM pt’s 20-30 mins vs 5-10 Length of sedation longer in IM pt’s Median 129 minutes vs 80 Up to 365 minutes in IM group Study stopped early at nursing request due to increased length of recovery and increased rates of vomiting

More on Ketamine Conclusion – IM or IV? IV (1.5mg/kg) IM (4mg/kg) If already have an IV established 5-10 minute procedure planned Planning procedure longer than 20 minutes so that repeat doses may be given IM (4mg/kg) No IV access Planned procedure likely to take 15-20 minutes and you don’t want to repeat dose

Propofol Diprivan Hotly Contested Medication 1% propofol, 10% soybean oil and 1.2% purified egg phospholipid (emulsifier), with 2.25% of glycerol as a tonicity adjusting agent, and sodium hydroxide to adjust the pH Uncertain mechanism of action Hotly Contested Medication See “Poachers and Dabblers?”: ASA President’s Incautious Comment Riles Emergency Physicians, Annals of Emergency Medicine, Volume 50, Issue 3, Pages 264-267 (September 2007)

Propofol Standard Dose – 1mg/kg IV Rapid Onset of action – 45 seconds Repeat dose 0.5mg/kg IV Rapid Onset of action – 45 seconds Good amnesia Return to baseline function after completion of procedure 7 minutes

Propofol Study looking at propofol vs etomidate Increased subclinical respiratory depression 42% vs 34% Oxygen Desaturation 9.1% vs 9.5% Airway Repositioning 11% vs 13.3% Required BVM 4.6% vs 3.8% Decreased SBP from baseline 7.9mm vs 3.8mm

Propofol Conclusion - Level B Recommendation Myoclonus* 1.8% vs 20% Time to return of baseline* 6.8 mins vs 8.8 mins Equally high level of patient satisfaction Doses used Propofol 1mg/kg then 0.5mg/kg q3 mins prn Etomidate 0.1mg/kg then 0.05mg/kg q3-5 prn Conclusion - Level B Recommendation Propofol can be safely administered for procedural sedation and analgesia in the ED

Ketofol Ketamine and propofol in same syringe in 1:1 mixture 5mg/mL for each drug Typical dose – 0.75mg/kg of each 100Kg person – 15mL Median Recovery – 15 minutes Adverse events – respiratory depression, emergence phenomenon

Ketofol Friedberg used prospectively on 1264 pt’s in office based study Annals January 2007 – 114 pts Avg BP increased Median decrease in O2 Sat – 2% 6 pts had hypoxia 3 required airway repositioning 1 required BVM for 2 minutes 3 pts had dysphoria 2 mild, 1 required versed No vomiting

Etomidate Sedative hypnotic – GABA receptor Hemodynamically Stable Rapid onset – <1 minute Short duration of effect 3-5 minutes without redosing Rapid Recovery Dose Dependent About 10 minutes for 0.1 – 0.15 mg/kg

Etomidate Myoclonus – 20% Desaturation Overall – High level of patient satisfaction 114/120 pts would agree to use again Level C Recommendation Etomidate can be safely administered for procedural sedation and analgesia in the ED

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Brevital (methohexital) Barbiturate, acts on GABA receptors Introduced in early 1960’s Published study looking at ED use in 1991 Hemodynamically Stable Avg 1.8mm drop in SBP Rapid Onset – about 1 minute Short duration – about 8 minutes Good amnesia

Brevital Respiratory depression is biggest drawback 22% required BVM Pulse oximetry only used on 19/102 pts Typical dose for procedural sedation is 0.75-1mg/kg No formal recommendations given

Versed/Fentanyl Initial dose Falling out of favor in research articles 100mcg/kg fentanyl given first 0.1mg/kg versed bolus then titrate Falling out of favor in research articles Longer time of recovery 72 minutes Other variants: versed/dilaudid, versed/morphine, versed/demerol Provides both analgesia and amnesia

Versed/Fentanyl Available in most ED’s Reversal agents readily available Level B Recommendation The combination of fentanyl and midazolam is effective for procedural sedation and analgesia in the ED.

Summary of Key Points Procedural Sedation is a continuum Difference between moderate and deep sedation is responsiveness Preparation is Key Assess the Patient – H&P Fasting Status – no evidence to support Proper personnel At least one person qualified to monitor patient

Summary of Key Points Proper equipment Monitoring Monitor, Pulse ox, Oxygen, BVM, Suction, ACLS and Reversal Medications Crash cart, intubation equipment available but not necessarily at the bed side Monitoring Someone needs to monitor vitals, appearance, responsiveness, drugs given Before, during, and after procedure Continuous pulse ox Consider capnometry

Summary of Key Points Titrate medications to effect Slower administration shows fewer adverse effects Be prepared to handle 1 level deeper than your target level of sedation