Procedural sedation and analgesia in the emergency department. Canadian consensus guidelines

The Journal of Emergency Medicine, Vol. 17, No. 1, pp. 145–156, 1999 Copyright © 1999 Elsevier Science Inc. Printed in the USA. All rights reserved 0736-4679/99 $–see front matter

PII S0736-4679(98)00135-8

Canadian Perspectives

PROCEDURAL SEDATION AND ANALGESIA IN THE EMERGENCY DEPARTMENT. CANADIAN CONSENSUS GUIDELINES Grant Innes,

MD,*

Mike Murphy,

MD,†

Cheri Nijssen–Jordan, Alan Drummond, MD¶

MD,‡

James Ducharme,

MD,§

and

Emergency Medicine Working Committee, Canadian Association of Emergency Physicians, *Vancouver, British Columbia; †Halifax, NS; ‡Calgary, Alberta; §St. John, New Brunswick; and ¶Perth, Ontario, Canada Reprint Address: Grant Innes, MD, Department of Emergency Medicine, St. Paul’s Hospital, 1081 Burrard Street, Vancouver, BC, Canada V6Z 1Y6

e Keywords—sedation; conscious sedation; analgesia; procedural sedation; guidelines; pain control

e Abstract—Procedural sedation and analgesia are core skills in emergency medicine. Various specialty societies have developed guidelines for procedural sedation, each reflecting the perspective of the specialty group. Emergency practitioners are most likely to embrace guidelines developed by people who understand emergency department (ED) skills, procedures, conditions, and case mix. Recognizing this, the Canadian Association of Emergency Physicians (CAEP) determined the need to establish guidelines for procedural sedation in the ED. In March, 1996, a national emergency medicine (EM) working committee, representing adult and pediatric emergency physicians, was established. This committee teleconferenced with representatives of the Canadian Anesthetic Society (CAS) to identify problems, perspectives, and controversial issues, and to define a process for guideline development. The EM committee subsequently reviewed existing literature, determined levels of evidence, and developed the document, which evolved based on feedback from the CAS and CAEP Standards Committees. The final version was approved by the CAEP Standards Committee and the CAEP Board of Directors, then submitted for peer review. These guidelines discuss the goals, definitions, and principles of ED sedation, and make recommendations for pre-sedation preparation, patient fasting, physician skills, equipment and monitoring requirements, and post-sedation care. The guidelines are aimed at non-anesthesiologists practicing part-time or fulltime emergency medicine. They are applicable to ED patients receiving parenteral analgesia or sedation for painful or anxiety-provoking procedures. They are intended to increase the safety of procedural sedation in the ED. © 1999 Elsevier Science Inc.

INTRODUCTION Painful procedures are unavoidable in emergency medicine. Increasingly, physicians are acknowledging that it is inhumane to perform these procedures without taking steps to minimize the associated pain and anxiety (1– 8). The term “conscious sedation” is widely used to describe the process of providing analgesia, sedation, and amnesia for patients undergoing painful procedures; however, this term is misleading and should be abandoned. A better term is “procedural sedation and analgesia” (3,9), which also will be referred to as “procedural sedation” in the following document. Potent opioids and sedating agents are safe and effective (10 –27) when used by competent people in controlled environments, but tragic misadventures in dental offices, endoscopy suites, and emergency departments have made the use of these agents by non-anesthesiologists a controversial issue (28,29). While anesthesiologists have unique qualifications to provide sedation, their availability is variable and unreliable (30), and is limited by commitments to the operating room (31). Consequently, various specialty societies have developed guidelines (4,9,21,31–33) for procedural sedation, each reflecting the viewpoint of the particular specialty group;

RECEIVED: 23 January 1998; ACCEPTED: 20 February 1998. 145

146

G. Innes et al.

but, because patients, procedures, and practitioner skills differ from specialty to specialty and setting to setting, such guidelines are not universally relevant (4). Emergency department (ED) procedural sedation is unique for the following reasons: 1. Many patients undergo painful, non-elective procedures in the ED. 2. These procedures are generally brief, with the painful component lasting seconds to minutes, making them ill-suited to the operating room. 3. Most ED procedures can be abandoned immediately if patient deterioration occurs. 4. The following skills, intrinsic to safe outpatient analgesia and sedation, are core skills for emergency medicine practitioners: a. the ability to monitor respiratory and cardiovascular status, b. resuscitation skills, and the ability to deal with airway compromise, hypoventilation, and circulatory impairment (4). c. intimate knowledge of, and experience with major tranquilizers, sedative-hypnotics, opioids, and reversal agents. d. varying degrees of experience in providing procedural sedation for their patients.

CANADIAN GUIDELINES Procedural sedation and analgesia will continue to be essential components of emergency medicine. There is wide practice variation across the country and there are no established procedural sedation guidelines for Canadian emergency departments. While guidelines have been developed by other specialty societies (4,9,21, 31–33), emergency practitioners are most likely to accept guidelines developed by people who understand the disease spectrum we see, the skills we possess, the procedures we perform, and the conditions under which we work. ED guidelines, policies, and standards must be defined by emergency physicians. Recognizing this, the Canadian Association of Emergency Physicians (CAEP) determined the need to establish guidelines for procedural sedation in the ED. In March of 1996, an emergency medicine working committee, representing adult and pediatric emergency physicians, was established. This committee teleconferenced with representatives of the Canadian Anesthetic Society (CAS) to identify problems, perspectives, and controversial issues, and to define a process for guideline development. Subsequently, a first draft was prepared and circulated to CAS and CAEP representatives. After

extensive revision, a second draft was recirculated for comment. In June of 1997, the document was presented to the CAS Standards Committee. It was further revised to address CAS concerns, then submitted to and approved by the CAEP Standards Committee and the CAEP Board of Directors. We wish to acknowledge the valuable contribution of the CAS, but clarify that these are CAEP guidelines, developed primarily by emergency physicians, to facilitate the safer application of procedural sedation techniques in Canadian emergency departments.1 Readers should be aware that, because adverse outcomes associated with sedation procedures are rare events, the recommendations included in this document are based primarily on case reports and expert opinion rather than on the outcomes of clinical trials. The working committee and the CAEP Board of Directors believe, however, that it is inappropriate to delay guideline development and implementation pending the outcomes of ongoing or future clinical trials.

FOCUS AND APPLICATION These guidelines are aimed at non-anesthesiologists practicing part-time or full-time emergency medicine. They are applicable to emergency department patients receiving parenteral analgesia or sedation for painful or anxiety-provoking procedures. The guidelines are intended to be general in application. The choice of specific techniques and drugs will depend on the clinical situation and the practitioner’s ability and experience.

GOALS OF PROCEDURAL SEDATION AND ANALGESIA 1. To consider patient safety and welfare the first priority. 2. To provide adequate analgesia, anxiolysis, sedation, and amnesia during the performance of painful diagnostic or therapeutic procedures in the ED. 3. To minimize the adverse psychological responses associated with painful or frightening medical interventions. 4. To control motor behavior that inhibits the provision of necessary medical care. 5. To return the patient to a state in which safe discharge is possible.

1

For guidelines dealing with the provision of general anesthesia, physicians are referred to the CAS’s “Guidelines to the Practice of Anesthesia” (34).

ED Sedation

147

Table 1. Drugs Commonly Used For Procedural Sedation and Analgesia (4)

THE SEDATION CONTINUUM

A. Medications for sedation 1) Benzodiazepines: midazolam and diazepam (7,18,19,23–28,36,37,48–58) 2) Ultrashort-acting barbiturates: sodium thiopentone and methohexitone (37,53,59,60) 3) Chloral hydrate* (37,58,61) B. Medications for analgesia 1) Potent opioids: fentanyl and alfentanyl (7,18,20,24,26,36,37,62–66) 2) Opioids: meperidine and morphine C. Medications for sedation and analgesia 1) Intramuscular meperidine, promethazine, and chlorpromazine* (59,65,67–69) 2) Nitrous oxide (32,38) 3) Ketamine (10,11,23,25,36–38,53,56,57,69–72) 4) Propofol (38,54,73) D. Medications for neurolepsis 1) Haloperidol and droperidol (74,75)

Differentiating light and deep sedation is simplistic, and procedural sedation cannot be viewed as a binary process with two possible endpoints (light vs. deep). Rather, “sedation and analgesia” refers to a continuum with infinite possible endpoints (Figure 1). The practitioner must recognize that the optimal endpoint in any situation will depend on the procedure to be performed, the amount of pain to be inflicted, and the patient’s anxiety level and cardiorespiratory reserve (21), with different procedures demanding different levels of sedation and analgesia (Table 2). Painful procedures often require both sedation and analgesia. Non-painful procedures in uncooperative patients require sedation without analgesia. Some procedures may require only anxiolysis. The patient’s specific needs should be considered when determining whether to administer only a sedating agent or agent(s) that provide both sedation and analgesia. Moderately painful procedures, such as shoulder relocation in apprehensive patients, may require “moderate” sedation and analgesia. Extremely painful procedures (e.g., simultaneous invasive trauma procedures) and procedures dependent on patient cooperation (e.g., tongue or vermilion border repair in children) may mandate deeper sedation and analgesia. Violent and psychotic patients frequently require neurolepsis. The specific clinical situation will determine what drugs are chosen and what doses of those drugs are necessary. The ideal agent for procedural sedation and analgesia would provide analgesia, sedation, amnesia, motor control, have a rapid onset and short duration, and at the

* Not recommended by the working committee.

DEFINITIONS

1. General anesthesia refers to a state of unconsciousness plus partial or complete loss of protective reflexes including the inability to independently maintain an airway (21,32). This state is only appropriate in the ED for patients who are intubated and ventilated. 2. Neurolepsis, a state of reduced motor activity, reduced anxiety, and indifference to surroundings, is induced by major tranquilizers, typically haloperidol or droperidol. Neurolepsis is useful in the ED to control violent or agitated patients, particularly those who pose a risk to themselves or others. Combining opioids with neuroleptics produces a state known as neuroleptanalgesia, which is desirable when dealing with combative patients who require analgesia. See Table 1. 3. Dissociative sedation (10,11,22,35), a ketamineinduced state, is characterized by analgesia, sedation, amnesia, and catalepsy with relatively preserved ventilatory drive and airway protective reflexes. 4. Deep sedation, like general anesthesia, is a state of unconsciousness from which the patient is not easily aroused, which may be accompanied by impairment of airway protective reflexes and ventilatory drive (21). 5. Light sedation, the usual goal for ED procedural sedation, is a controlled lessening of a patient’s awareness and pain perception (3) that leaves the patient able to respond to verbal or physical stimulation, and to continuously and independently maintain a patent airway and adequate ventilatory drive (4,9,21). 6. Anxiolysis is a state of diminished apprehension with no change in level of awareness (4).

Figure 1. The sedation continuum.

148

G. Innes et al. Table 2. Potential Indications for Procedural Sedation and Analgesia I. Sedation with little or no analgesia Controlling movement for CT scan and other diagnostic procedures Silt lamp examination in children Foreign body removal (eye, ear, nose) The terrified, uncontrollable child, as an adjunct to local anesthesia Lumbar puncture Posterior nasal packing II. Procedural sedation and analgesia (from ‘‘lighter’’ to ‘‘deeper’’ required endpoints) Disimpaction; removal of vaginal or rectal foreign bodies Hand and fingertip injuries in children (adjunct to local anesthesia) Reducing fractures and dislocations; applying traction splints Peritoneal lavage Burn debridement Intraosseus lines Electrical cardioversion Scrubbing ‘‘road rash’’ I & D of Bartholin or perianal abscess Complex pediatric lacerations requiring patient cooperation (tongue, eyelid, vermilion border) III. Neurolepsis The psychotic or violent patient The agitated or combative trauma patient (neuroleptanalgesia) IV. Dissociative sedation (ketamine) In children In Adults Fractures and dislocations Asthma intubation Abscess I & D Hemodynamically unstable patient Multiple trauma procedures Trauma resuscitation Tongue lacerations Longer duration painful procedures Hand and fingertip repairs Burn debridement or road rash Sexual assault examination Penile pathology (zippers, lysis of foreskin adhesions)

same time be safe, effective, simple to administer, and reversible (36). No such agent exists, and emergency physicians must choose from or combine agents with diverse properties (37). Commonly used sedation and analgesic agents are listed in Table 1. Physicians should gain expertise with a limited number of these agents rather than using many of them on a sporadic basis.

CONTRAINDICATIONS TO PROCEDURAL SEDATION AND ANALGESIA 1. Lack of personnel experienced in airway management or advanced life support, or unfamiliarity with medications being administered for sedation and analgesia. 2. Lack of appropriate monitoring equipment or inability to monitor the patient during the procedure and recovery period. 3. Allergy or sensitivity to relevant medications. Relative contraindications include facial, dental, or airway abnormalities that would preclude tracheal intubation, patients at high risk of vomiting and aspiration, and hemodynamically or neurologically unstable patients.

PRINCIPLES OF SEDATION AND ANALGESIA 1. Sedation and analgesia are distinct processes. Some patients require primarily sedation, some primarily analgesia, and some both. Drug and technique should be selected based on the effect desired. 2. Different patients have different “endpoints” (Table 2). Intravenous titration is the only reliable way to achieve a given endpoint. Drug doses for procedural sedation are based on titration to a desired endpoint, not calculated on a milligram-per-kilogram basis (38). 3. Rapid drug boluses (“i.v. push”) are more likely to cause unexpected deterioration than is gradual drug administration over 1–2 min. 4. There is a period after drug administration during which the risk of patient deterioration is highest. Shortacting agents are associated with a briefer risk period and more rapid recovery if an endpoint is overshot. 5. General anesthesia in the ED should be viewed as an adverse outcome to be avoided, and most ED procedures do not require levels of sedation associated with loss of protective reflexes or ventilatory drive. Patients should not be sedated to the extent that active upper airway protective reflexes are compromised. If, in the clinician’s judgment, a procedure or situation warrants “deep” sedation, to levels approaching general anesthe-

ED Sedation

sia, the clinician should consider the feasibility of transferring the patient to the operating room or using a technique such as dissociative sedation that is less likely to cause cardiorespiratory compromise. If “deep” sedation is necessary (e.g., for emergent electrical cardioversion), the practitioner must be prepared to ventilate and stabilize cardiorespiratory function, and to provide the same level of care and monitoring that would be available in the operating room setting (39). In addition, if a state approaching general anesthesia is induced, the physician performing the sedation should focus attention exclusively on the sedation process and should not simultaneously perform the therapeutic procedure. 6. Children, the elderly, and patients with underlying cardiorespiratory disease constitute higher risk groups. Children tend to require higher milligram-per-kilogram drug doses to achieve a given endpoint, and have narrower safety margins. Infants and children under 6 months of age are at higher risk from sedation procedures because of slower drug clearance, decreased protein binding, increased drug passage across the blood brain barrier, and a lower ratio of lean to total body mass. The elderly are more prone to cardiorespiratory decompensation when given sedative or analgesic drugs and generally require lower milligram-per-kilogram doses. Emergency physicians must recognize these higher risk patients and proceed with sedation only if their level of expertise and experience justifies doing so. 7. Patients respond differently to drugs. Any sedative or analgesic, in sufficient dose, can cause cardiorespiratory compromise, and any patient can unexpectedly progress to a deeper than desired level of sedation and analgesia. Hypoventilation, apnea, and hypotension may occur (7). A physician capable of airway management and resuscitation (3,4) must be present during the sedation process. Practitioners should not sedate patients unless they are confident in their ability to deal with the possible complications.

PRE-SEDATION PREPARATION Emergent situations may mandate immediate intervention, but when patient stability and the clinical situation permit, an organized pre-sedation preparation is optimal (4,9,31,32). The patient (or the legal guardian in the case of minors or legally incompetent adults) should be informed of the objectives of sedation, the benefits, risks, and limitations of the therapy, the anticipated changes in patient behavior during and after sedation, and the expected duration of post-sedation monitoring. Written or verbal informed consent should be obtained and this should be documented.

149 Table 3. American Society of Anesthesiologists (ASA) Physical Status Classification I. Healthy patient II. Mild systemic disease—no functional limitation III. Severe systemic disease—definite functional limitation IV. Severe systemic disease that is a constant threat to life V. Moribund patient not expected to survive without the operation

A pertinent medical history should be elicited, including medications, allergies, time of last oral intake, history of sedation or general anesthesia, and any related complications (9). A major goal of the pre-sedation evaluation is to assess the degree of physiologic reserve of vital organ functions, including the cardiovascular, respiratory, and central nervous system. The physical examination should include pulse, respiratory rate, blood pressure, level of consciousness, weight, and evaluation of the airway (9). Specific note should be made of beards or facial deformities that would impede mask ventilation or intubation. The patient’s ASA status (Table 3) should be determined. For non-emergent procedures, ED sedation and analgesia should be limited to ASA class 1 or 2 patients (21,40). For non-emergent procedures in patients with limited physiologic reserve (ASA level 3 or 4), practitioners should consult an anesthesiologist if sedation to the point of unresponsiveness or general anesthesia appears necessary (9).

PRE-SEDATION FASTING Aspiration of gastric contents is a rare but dreaded complication of general anesthesia. Pre-procedure fasting decreases aspiration risk, though optimal fasting duration remains controversial. Light sedation with preserved airway reflexes is unlikely to provoke aspiration, but deeper sedation may compromise protective reflexes and increase risk. No evidence-based guidelines exist for optimal fasting duration prior to ED procedural sedation, and there are insufficient data in the literature to show that fasting improves outcomes in patients undergoing ED procedural sedation (9). It is logical to assume, however, that aspiration risk is lower with an empty stomach and that some period of pre-procedure fasting is desirable. In the absence of reliable data to define this period, the American Society of Anesthesiologists (9) has recommended 6 h NPO for solids and 2 h for liquids. In all cases, the urgency of the procedure and the desired depth of sedation should be balanced against the risk associated with inadequate fasting.

150

G. Innes et al.

PHYSICIAN SKILLS A physician competent at sedation and analgesia as well as advanced life support and airway management must be present in the ED throughout the procedure and recovery period (4,9,32). Physicians performing procedural sedation should understand the pharmacology of the drugs they are administering and must be familiar with any relevant antagonists (3,9).

STAFFING An additional qualified patient observer (9,32,40), usually a physician or nurse, must be present during the sedation. This person’s responsibility is to observe the patient’s airway patency, adequacy of ventilation, vital signs, and any monitoring devices in use. The patient observer may assist in other minor, interruptible tasks (9). If available, a respiratory technologist is a good choice of ancillary personnel.

EQUIPMENT AND SETTING Sedation should take place in a central, well monitored area of the emergency department. In addition to sedating drugs and relevant reversal agents, a pulse oximeter and blood pressure cuff, or automated blood pressure monitor, should be available at the bedside. Suction, an oxygen source, a nasal cannula, and an age-appropriate oral airway and bag-valve-mask are essential (9). The establishment of an i.v. line is at the physician’s discretion. Equipment that should be readily available but not necessarily at the bedside include a cardiac monitordefibrillator, a laryngoscope, age-appropriate endotracheal tubes, and a cardiac arrest cart with standard resuscitation drugs. Table 4 is a list of equipment that should be available in the ED.

MONITORING The degree of physiologic monitoring required is directly proportional to the type and level of sedation (40). Patients who remain awake and respond appropriately to verbal stimulation need no special monitoring. Patients who are sedated to the extent that their eyes are closed require specific monitoring, which should begin prior to drug administration and continue throughout the recovery phase. Vital signs, including pulse, blood pressure, and re-

Table 4. Recommended Emergency Equipment (9,32) Airway Management Equipment Oxygen source Suction source Face masks: infant, child; small, medium, and large adult Breathing bag and valve set (adult and pediatric) Oral airways: infant, child; small, medium, and large adult Nasal airways: small, medium, and large Laryngoscope handles (tested) Laryngoscope blades: Straight (Miller) No. 1, 2, 3 Curved (Macintosh) No. 2, 3, and 4 Endotracheal tubes: Uncuffed: 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 Cuffed: 6, 0, 6.5, 7.0, 7.5, 8.0 Stylettes Surgical lubricant Suction catheters (appropriate sizes for endotracheal tubes) Yankauer-type suction Nasogastric tubes Nebulizer attachment Gloves Magill forceps Intravenous Equipment Intravenous catheters: 24, 22, 20, 18, and 16-gauge Tourniquets Alcohol swabs Adhesive tape Assorted syringes; 1, 3, 6, and 12 mL Intraosseous needle Intravenous tubing: Pediatric drip (60 drops/mL) Pediatric burette type Extension tubing Intravenous fluid: normal saline Three-way stopcocks Pediatric intravenous boards Sterile gauze pads Assorted i.v. needles: 22–20, and 18-guage Pharmacologic agents Naloxone Flumazenil Epinephrine Atropine Lidocaine Glucose (10% and 50%) Diphenhydramine Hydrocortisone, methylprednisolone, or dexamethasone Diazepam or midazolam Succinylcholine

spiratory rate, should be recorded before and after drug administration, at regular intervals during the procedure until the patient is fully awake, and at the time of discharge (9). During the sedation procedure, the physician or support person should frequently assess the patient’s spontaneous alertness, response to voice, and if necessary, response to pain (19). The physician or support person should carefully observe the adequacy of spontaneous ventilations and the color of skin and mucous membranes. All patients who are sedated to the extent that their eyes are closed should have oxygen saturation monitoring (9,19) throughout the procedure, preferably using an oximeter that provides a variable pitch beep, reflecting

ED Sedation

151

changes in oxygen saturation and pulse rate. Though pulse oximetry does not assure adequate ventilation, it decreases the risk of unrecognized oxygen desaturation (41– 43). Supplemental oxygen is often provided during sedation. Physicians should be aware that oxygen administration may increase oxygen saturation in the face of hypoventilation, and that undetected CO2 retention may occur (44). For documentation purposes, a specific procedural sedation record is recommended (Figure 2). Drug administration times and doses should be recorded. Vital signs and oxygen saturation (when monitored) should be charted before drug administration and regularly (34) during the procedure until the patient is fully awake, and prior to discharge (9).

DRUG ADMINISTRATION Specific technique, drug, and drug dose will vary depending on the physician, the physician’s experience, the clinical situation, and patient factors (3). When i.v. benzodiazepines or opioids are administered, flumazenil and naloxone should be available at the bedside. These agents should be used to reverse drug-induced respiratory depression (45), not prophylactically in stable patients, since antagonist use is associated with increased re-sedation risk (46). Table 1 lists drugs that are commonly used for ED sedation and analgesia.

POST-SEDATION CARE Vital signs and respiratory status should be monitored until the patient is awake and alert. The patient should be observed until discharge criteria are met (4,8,9), including the following: 1. Airway patency, ventilation, cardiovascular function, and hydration are satisfactory. 2. The patient’s level of consciousness has returned to baseline. For children or handicapped patients incapable of the usual responses, the presedation level of responsiveness or a level as close as possible to that should be achieved. 3. The patient can sit unassisted (if age appropriate). 4. The patient can take oral fluids without vomiting. 5. The patient, or a responsible person who will be with the patient, can understand the discharge instructions (Appendix 1). 6. If i.v. reversal agents have been given, the patient should be observed for at least 2 h, to ensure that resedation does not occur (9). Verbal and written discharge instructions should be given to the patient or their guardian (Appendix 1), and

the time and condition of the patient on discharge should be documented.

SUMMARY OF RECOMMENDATIONS AND LEVELS OF EVIDENCE References for the following recommendations are provided in the text. Class of recommendation and levels of evidence, as defined in Appendix 2, are provided in brackets after each recommendation (47).

A. Pre-sedation Preparation and Assessment When patient stability and the clinical situation permit, the following pre-sedation steps are recommended: 1. The patient or the legal guardian should be informed of the objectives, benefits, risks, and limitations of sedation. Written or verbal informed consent should be obtained. [Class C, Level III] 2. Past medical history, medications, allergies, time of last oral intake, history of sedation or anesthesia, and any related complications should be obtained. Vital signs, level of consciousness, weight, and airway evaluation should be performed. [Class B, Level II-3] 3. The patient’s ASA status should be determined. For non-emergent procedures, ED sedation and analgesia should be limited to ASA class 1 or 2 patients. For non-emergent procedures in significantly compromised patients (ASA level 3 or 4), practitioners should consult an anesthesiologist if sedation to the point of unresponsiveness or general anesthesia appears necessary. [Class B, Level III]

B. Pre-sedation Fasting Patients who require procedural sedation should be kept NPO after arriving in the ED. In the setting of severe pain or a life- or limb-threat, sedation should not be delayed to optimize NPO time, but pre-treatment with i.v. metoclopramide and ranitidine should be considered, and practitioners must be prepared to deal with regurgitation or vomiting. In elective situations, where delaying a procedure will not expose the patient to severe ongoing pain or increased morbidity, the practitioner should consider keeping the patient NPO for 2 h (liquids) or 6 h (solids) before sedation. In all cases, the urgency of the procedure and the desired depth of sedation should be weighed against the risk associated with inadequate fasting. [Class C, Level III]

152

Figure 2. Sample ED procedural sedation record.

G. Innes et al.

ED Sedation

C. Physician Skills [All recommendations Class B, Level III] 1. Physicians performing procedural sedation should understand the pharmacology of the drugs they are administering and must be familiar with any relevant antagonists. 2. A physician capable of airway management and advanced life support should be present during the sedation process and should be immediately available in the ED through the recovery period. 3. Practitioners should not sedate patients unless they are confident in their ability to deal with the possible complications.

153

fully awake, and at the time of discharge. [Class B, Level III] 3. Pulse oximetry should be initiated prior to drug administration and continued until the patient is fully awake. [Class A, Level II-2]

G. Recording Drug administration times and doses should be recorded. Vital signs and oxygen saturation (when monitored) should be documented before drug administration, at regular intervals during the procedure until the patient is fully awake, and prior to discharge. A specific procedural sedation record is recommended. [Class C, Level III]

D. Staffing An additional qualified patient observer, usually a physician or nurse, must be present during the sedation. This person’s responsibility is to observe the patient’s airway patency, adequacy of ventilation, vital signs, and any monitoring devices in use. They may assist in other minor, interruptible tasks. [Class B, Level III]

E. Equipment and Setting 1. Sedation should take place in a central, well-monitored area of the ED. [Class B, Level III] 2. Sedating drugs and relevant antagonists should be available at the bedside. [Class B, Level III] 3. Suction, an oxygen source, a nasal cannula, and an age-appropriate oral airway and bag-valve-mask should be available at the bedside. [Class B, Level II-3] 4. A cardiac monitor-defibrillator, a laryngoscope, age-appropriate endotracheal tubes, and a cardiac arrest cart with standard resuscitation drugs should be available in the department. [Class B, Level III]

F. Patient Monitoring Patients who are sedated to the extent that their eyes are closed require specific monitoring, which should begin prior to drug administration and continue through the recovery phase. 1. During the sedation process, the physician or support person should frequently assess color, adequacy of ventilations, alertness, response to voice, and if necessary, response to pain. [Class B, Level III] 2. Pulse, blood pressure, and respiratory rate should be recorded before and after drug administration, at regular intervals during the procedure until the patient is

H. Postsedation Care 1. The patient should be observed until specified discharge criteria are met (Figure 2). [Class B, Level III] 2. If reversal agents have been given, the patient should be observed for at least 2 h, to ensure that resedation does not occur. [Class B, Level I] 3. Verbal and written discharge instructions should be given to the patient or the patient’s guardian. [Class C, Level III] 4. The condition of the patient on discharge should be documented. [Class C, Level III]

APPENDIX 1: POST-EMERGENCY DEPARTMENT SEDATION/ANALGESIA INSTRUCTIONS A. Instructions for children who have received sedation: Your child has been given a medicine that causes drowsiness. The medicine may also cause temporary clumsiness or poor balance, and can cause poor judgment, leading children to do things they wouldn’t normally do. For these reasons you must watch your child closely for the next eight hours. In particular, we recommend: 1. No food or drink for the next two hours. If your child is under a year of age, they may be fed half of a normal feeding one hour after you go home from the hospital. 2. No play that requires normal balance, strength, and coordination. Avoid swimming, biking, skating, climbing, being at heights, swing sets, monkey bars, or stairs for the next 12 h. Children who are allowed

154

to play in these situations while there is still medicine in their system may hurt themselves. 3. You must watch your child closely for the next 8 h. They should be supervised at all times. This is especially important for children who normally play outside alone. 4. They should not bathe, shower, cook, or use electrical devices for the next eight hours, unless you are watching them closely. If you notice anything unusual about your child or have any questions, please contact the emergency department at (phone number of emergency department).

G. Innes et al.

Level of Evidence I Evidence from at least 1 randomized controlled trial II-1 Evidence from well designed cohort or case-control studies, usually from more than 1 center or research group II-2 Evidence from well designed controlled trials but without randomization II-3 Dramatic results from uncontrolled experiments III Opinions of experts, findings from descriptive studies, or reports of expert committees

REFERENCES B. Instructions for adults who have received sedation: 1. You have been given a medicine that causes drowsiness. The medicine may also cause temporary clumsiness or poor balance, and can cause poor judgment. These effects can last several hours. You should avoid dangerous activities, including bicycling, swimming, driving a vehicle, operating machinery, or working at heights until the effects of the medicine have completely passed. 2. You may temporarily feel sick, weak, or dizzy. This is normal. Some people will vomit if they eat too soon. As soon as you feel like you can drink without vomiting, you should try water, juice, or soup. You can progress to solid foods if the fluids do not cause nausea and you are feeling well. 3. If pain killers have been prescribed for you, ask the doctor how soon it is safe to take them. 4. You should not take alcohol, sleeping pills, or medicines that cause drowsiness for at least 24 h. If you have other questions or concerns, please contact the emergency department at (phone number of emergency department).

APPENDIX 2: CLASS OF RECOMMENDATION AND LEVELS OF EVIDENCE (47) Class of Recommendation: A. B. C. D.

Good evidence to support procedure or treatment Fair evidence to support procedure or treatment Poor evidence to support procedure or treatment Fair evidence that procedure or treatment should not be used E. Good evidence that procedure or treatment should not be used

1. Yaster M. Pain relief. Pediatrics 1995;95:427– 8. 2. US Department of Health and Human Services. Public Health Service, Agency for Health Care Policy and Research, Acute Pain Management Guideline Panel. Clinical practice guideline, Acute pain management: Operative or medical procedures and trauma. February. 1992. 3. American College of Emergency Physicians. Policy Statements: The use of pediatric sedation and analgesia. Ann Emerg Med 1993;22:626 –7. 4. Sacchetti A, Schafermeyer R, Gerardi M, et al. Pediatric sedation and analgesia. Ann Emerg Med 1994;23:237–50. 5. Jylli L, Olsson GL. Procedural pain in a pediatric surgical emergency unit. Acta Paediatr 1995;84:1403– 8 6. Baxter JK. Stewart smiled. Pediatrics 1993;91:1018. 7. Yaster M, Nichols DG, Deshpande JK, Wetzel RC. Midazolam– Fentanyl i.v. sedation in children: Case report of respiratory arrest. Pediatrics 1990;86:463– 6. 8. Baraff LJ. Conscious sedation of children. Ann Emerg Med 1994; 24:1170 –2. 9. American Society of Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 1996;84:459 –71. 10. Green SM, Nakamura R, Johnson NE. Ketamine sedation for pediatric procedures: Part 1: A prospective series. Ann Emerg Med 1990;19:1024 –32. 11. Green SM, Johnson NE. Ketamine sedation for pediatric procedures: Part 2: Review and implications. Ann Emerg Med 1990;19: 1033– 46. 12. Wright SW, Chudnofsky CR, Dronen SC, Wright MB, Borron SW. Midazolam use in the ED. Am J Emerg Med 1990;8:97–100 13. Pohlgeers AP, Friedland LR, Keegan–Jones L. Combination fentanyl and diazepam for pediatric conscious sedation. Acad Emerg Med 2, 879 – 83 14. Pruitt JW, Goldwasser MS, Sabol SR, Prstojevich SJ. Intramuscular ketamine, midazolam, and glycopyrrolate for pediatric sedation in the ED. J Oral Maxillofac Surg 1995;53:13–18. 15. Ramoska EA, Linkenheimer R, Glasgow C. Midazolam use in the ED. J Emerg Med 1991;9:247–51 16. Lerman B, Yoshida D; Levitt MA. A prospective evaluation of the safety and efficacy of methohexital in the ED. Am J Emerg Med 1996;14:351– 4 17. D’Eramo EM. Morbidity and Mortality with outpatient anesthesia. The Massachusetts experience. J Oral Maxillofac Surg 1992;50: 700 – 4. 18. Graff KJ, Kennedy RM, Jaffe DM. Conscious sedation for pediatric orthopaedic emergencies. Pediatr Emerg Care 1996;12:31–5. 19. Sievers TD, Yee JD, Foley ME, Blanding PJ, Berde CB. Midazolam for conscious sedation during pediatric oncology procedures: Safety and recovery parameters. Pediatrics 1991;88:1172–9. 20. Chudnofsky CR, Wright SW, Dronen SC, et al. The safety of fentanyl use in the ED. Ann Emerg Med 1989;18:635–9.

ED Sedation 21. NIH Consensus Conference. Anesthesia and sedation in the dental office. JAMA 1985;254:1073– 6. 22. Epstein FB. Ketamine dissociative sedation in pediatric emergency medical practice. Am J Emerg Med 1993;11:180 –2. 23. Parker RI, Mahan RA, Giugliano D, Parker MM. Efficacy and safety of intravenous midazolam and ketamine as sedation for therapeutic and diagnostic procedures in children. Pediatrics 1997; 99:427–31. 24. Cragg AH, Smith TP, Berbaum KS, Nakagawa N. Randomized double-blind trial of midazolam/placebo and midazolam/fentanyl for sedation and analgesia in lower extremity angiography. AJR 1991;157:173– 6. 25. Moscona RA, Ramon I, Ben–David B, Isserles S. A comparison of sedation techniques for outpatient rhinoplasty. Midazolam vs. midazolam plus ketamine. Plast Reconstr Surg 1995;96:1066 –74. 26. Weisman SJ, Schecter NL. Therapeutic orphans. Pediatrics 1992; 89:688 – 89. 27. Hennes HM, Wagner V, Bonadio WA, et al. The effect of oral midazolam on anxiety of preschool children during laceration repair. Ann Emerg Med 1990;19:1006 –9 28. Health Canada. Midazolam: A Wake up call. Can Med Assoc J 1996;155:70 –1. 29. Bailey PL, Pace NL, Ashburn MA, Moll JWB, East KA, Stanley TH. Frequent hypoxemia and apnea after sedation with midazolam and fentanyl. Anesthesiology 1990;73:826 –30. 30. Drummond AJ. Working group on anesthesia in the emergency department. J Emerg Med 1995;13:279 – 81. 31. Holzman RS, Cullen DJ, Eichhorn JH, Philip JH. Guidelines for sedation by nonanesthesiologists during diagnostic and therapeutic procedures. The Risk Management Committee of the Department of Anesthesia of Harvard Medical School. J Clin Anesth 1994;6: 265–76 32. Committee on Drugs, American Academy of Pediatrics. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics 1992;89:1110 –15. 33. Bell GD, McCloy RF; Charlton JE, et al. Recommendations for standards of sedation and patient monitoring during gastrointestinal endoscopy. Gut 1991;32:823–27. 34. The Canadian Anesthetist’s Society. Guidelines to the Practice of Anesthesia. World Wide Web. 1997; CAS. 35. White PF, Way WL, Trevor AJ. Ketamine-its pharmacology and therapeutic uses. Anesthesiology 1982;56:119 –36. 36. Schultz CH. Conscious sedation in the emergency department. WJM 1993;159:600 –1. 37. Berman D, Graber D. Sedation and analgesia. Emerg Med Clin NA 1992;10:691–704. 38. Tobias JD, Rasmussen GE. Pain management and sedation in the pediatric intensive care unit. Pediatr Clin NA 1994;41:1269 – 86. 39. Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Accreditation Manual for Hospitals. Chicago, Illinois, JCAHO. 1993;1:165–70. 40. Proudfoot J. Analgesia, anesthesia, and conscious sedation. Emerg Med Clin NA 1995;13:357–78. 41. Cote CJ, Goldstein EA, Cote MA, Hoaglin DC, Ryan JF. A single-blind study of pulse oximetry in children. Anesthesiology 1988;68:184 – 8. 42. Cote CJ, Rolf N, Liu LMP, et al. A single-blind study of combined pulse oximetry and capnography in children. Anesthesiology 1991; 74:980 –7. 43. Wright SW. Conscious sedation in the emergency department. The value of capnography and pulse oximetry. Ann Emerg Med 1992; 21:551–5. 44. Council on Scientific Affairs, American Medical Association. The use of pulse oximetry during conscious sedation. JAMA 1993;270: 1463– 8. 45. Gross JB, Blouin RT, Zandsberg S, Conard PF, Haussler J. Effect of flumazenil on ventilatory drive during sedation with midazolam and alfentanil. Anesthesiology 1996;85:713–20. 46. Ghouri AF, Ramirez Ruiz MA, White PF. Effect of flumazenil on

155

47.

48.

49.

50.

51.

52.

53.

54.

55.

56.

57.

58.

59.

60.

61. 62.

63.

64.

65.

66.

67. 68.

69.

recovery after midazolam and propofol sedation. Anesthiology 1994;81:333–9. Canadian Task Force on the Periodic Health Examination. The periodic health examination: 1987 update. Can Med Assoc J 1988; 138:618 –26. Yealy DM, Ellis JH, Hobbs GD, Moscati RM. Intranasal midazolam as a sedative for children during laceration repair. Am J Emerg Med 1992;10:584 –7 Connors K, Terndrup TE. Nasal vs. oral midazolam for sedation of anxious children undergoing laceration repair. Ann Emerg Med 1994;24:1074 –9. Shane SA, Fuchs SM, Khine H. Efficacy of rectal midazolam for the sedation of preschool children undergoing laceration repair. Ann Emerg Med 1994;24:1065–73. Wright SW, Chudnofsky CR, Dronen SC, et al. Comparison of midazolam and diazepam for conscious sedation in the emergency department. Ann Emerg Med 1993;22:201–5. Kaufman E, Davidson E, Sheinkman Z, Magora F. Comparison between intranasal and intravenous midazolam sedation in a dental phobia clinic. J Oral Maxillofac Surg 1994;52:840 –3. Rosenberg MK, Raymond C, Bridge PD. Comparison of midazolam/ketamine with methohexital for sedation during peribulbar block. Anesth Analg 1995;81:173– 4. Ronan KP, Gallagher TJ, George B, Hamby B. Comparison of propofol and midazolam for sedation in intensive care unit patients. Crit Care Med 1995;23:286 –93. Theroux MC, West DW, Corddry DH, et al. Efficacy of intranasal midazolam in facilitating suturing of lacerations in preschool children in the emergency department. Pediatrics 1993;91:624 –27. Van der Bijl P, Roelofse JA, Stander IA. Rectal ketamine and midazolam for premedication in pediatric dentistry. J Oral Maxillofac Surg 1991;49:1050 – 4. Roelofse JA, Joubert JJ, Roelofse PG. A double-blind comparison of midazolam alone and midazolam combined with ketamine for sedation of pediatric dental patients. J Oral Maxillofac Surg 1996; 54:838 – 44. McCarver–May DG, Kang J, Aouthmany M, et al. Comparison of chloral hydrate and midazolam for sedation of neonates for neuroimaging studies. J Pediatr 1996;128:573– 6. O’Brien JF, Falk JL, Carey BE, Malone LC. Rectal thiopental compared with i.m. meperidine, promethazine, and chlorpromazine for pediatric sedation. Ann Emerg Med 1991;20:644 –7. Lerman B, Yoshida D, Levitt MA. A prospective evaluation of the safety and efficacy of methohexital in the ED. Am J Emerg Med 1996;14:351– 4. Rumm PD, Takao RT, Fox DJ, Atkinson SW. Efficacy of sedation of children with chloral hydrate. South Med J 1990;83:1040 –2. Schutzman SA, Burg J, Liebelt E, et al. Oral transmucosal fentanyl citrate for premedication of children undergoing laceration repair. Ann Emerg Med 1994;24:1059 – 64. Lind GH, Marcus MA, Mears SL et al. Oral transmucosal fentanyl citrate for analgesia and sedation in the emergency department. Ann Emerg Med 1991;20:1117–20. DiPalma JA, Herrera JL, Weis FR, Dark–Mezick DL, Brown RS. Alfentanil for conscious sedation during colonoscopy. South Med J 1995;88:630 – 4. Bates BA, Schutzman S, Fleisher GR. A comparison of intranasal sufentanil and midazolam to i.m. meperidine, promethazine, and chlorpromazine for conscious sedation in children. Ann Emerg Med 1994;24:646 –51. Schechter NL, Weisman SJ, Rosenblum M, Bernstein B, Conrad L. The use of oral transmucosal fentanyll citrate for painful procedures in children. Pediatrics 1995;95:335–9. Snodgrass WR, Dodge WF. Lytic/“DPT” cocktail: Time for rational and safe alternatives. Ped Clin NA 1989;36:1285–91. Terndrup TE, Dire DJ, Madden CM, Davis H, Cantor RM, Gavula DP. A prospective analysis of i.m. meperidine, promethazine, and chlorpromazine in pediatric ED patients. Ann Emerg Med 1991; 20:31–5 Petrack EM, Marx CM, Wright MS. Intramuscular ketamine is

156 superior to meperidine, promethazine, and chlorpromazine for pediatric emergency department sedation. Arch Pediatr Adolesc Med 1996;150:676 – 81 70. Greene CA, Gillette PC, Fyfe DA. Frequency of respiratory compromise after ketamine sedation for cardiac catheterization in patients ,21 years of age. Am J Cardiol 1991;68:1116 –7. 71. Gutstein HB, Johnson KL, Heard MB, Gregory GA. Oral ketamine preanesthetic medication in children. Anesthesiology 1992;76:28 –33 72. Qureshi FA, Mellis PT, McFadden MA. Efficacy of oral ketamine

G. Innes et al. for providing sedation and analgesia to children requiring laceration repair. Pediatr Emerg Care 1995;11:93–7 73. Swanson ER, Seaberg DC, Mathias S. The use of propofol for sedation in the ED. Acad Emerg Med 1996;3:234 – 8 74. Clinton JE, Sterner S, Stelmachers Z, Ruiz E. Haloperidol for sedation of disruptive emergency patients. Ann Emerg Med 1987; 16:319 –22. 75. Thomas H, Schwartz E, Petrilli R. Droperidol vs. haloperidol for chemical restraint of agitated and combative patients. Ann Emerg Med 1992;21:407–13.