Meeting the Guidelines and Standards for Pediatric Sedation and Analgesia
Authors: Steven M. Green, MD, FACEP, Director, Emergency Medicine Residency Program, Associate Professor of Emergency Medicine, Loma Linda School of Medicine; William A. Wittlake, MD, FACEP, Chief and Interim Chair, Department of Emergency Medicine, Loma Linda University School of Medicine.
Peer Reviewer: Emory M. Petrack, MD, MPH, Director, Pediatric Emergency Medicine, Rainbow Babies and Children’s Hospital; Associate Professor of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH.
In the past decade, emergency physicians and pediatricians have witnessed dramatic advances in procedural sedation techniques for children. Scores of reports on midazolam, fentanyl, ketamine, and other drugs have greatly expanded our knowledge of the safety and efficacy of these agents. Children who traditionally endured forcible restraint or inadequate local anesthesia for painful procedures can now be effectively sedated with minimum discomfort and emotional disturbance. Sedation techniques have become an integral part of both emergency medicine and pediatric residency training, and the provision of such sedation is now a daily occurrence in most larger EDs nationwide.
Despite the striking safety of these agents, occasional complications occur. The age-old principle, "primum non nocere," holds true, and thus physicians must be careful to ensure that appropriate safeguards are in place to minimize the risk of adverse events. To address which specific safeguards are appropriate in specific circumstances, a series of sedation guidelines have been issued by various specialty societies, including the American Academy of Pediatrics (AAP), the American College of Emergency Physicians (ACEP), and the American Society of Anesthesiologists (ASA). Unfortunately, these guidelines conflict in many important respects, and controversy has arisen as to which is most appropriate and applicable to the ED setting.
To further complicate the discussion, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has mandated that hospitals develop institution-specific policies and procedures regarding procedural sedation, but does not specify which of the multiple specialty society guidelines they will accept. Some institutions have conservatively responded by developing lengthy and detailed policies requiring extensive documentation and high personnel demands. In some instances, these policies have been developed by anesthesiologists without input from the specialists for whom they are intended. Busy pediatric EDs are frequently squeezed in terms of available personnel, and concern has been voiced as to whether appropriate sedation techniques will increasingly be withheld due to the inability to comply with documentation-intensive policies.
The goal is to develop sound institutional policies that both provide adequate protection for patients and meet JCAHO expectations, yet without containing otherwise unnecessary or excessive requirements. To achieve this, emergency physicians and pediatricians should work with the hospital team developing and revising such policies and should be familiar with the main specialty society guidelines and JCAHO standards.
The Editor
It seems hard to believe that just over a decade ago there were no formal guidelines or standards for procedural sedation. Physicians administered such medications in varied clinical settings and applied individual judgment as to the need for specific monitoring devices and supporting personnel. However, in the mid-1980s there was a series of widely publicized deaths involving sedation in otherwise healthy individuals undergoing minor dental procedures.1,2 The dentists in question had administered IV narcotics and/or benzodiazepines and, while intent on the procedure at hand, had neglected to note complicating apnea until it was too late.
In response to this, two nearly identical consensus documents on sedation were published in August of 1985 by the National Institutes of Health (NIH) and the AAP.3,4 The NIH document referred specifically to dental patients, while the AAP version dealt generically with all children receiving sedation regardless of caregiver or location. Both set forth essentially identical definitions for three sedation "states:" conscious sedation, deep sedation, and general anesthesia. Specific suggestions were included for levels of personnel and monitoring appropriate to each sedation state.
Initially these documents were guidelines in the truest sense, in that clinicians could adopt them, modify them, or reject them as seen fit for individual circumstances. However, in the early 1990s, the JCAHO took a special interest in procedural sedation, with the central theme that the standard of sedation care provided should be comparable throughout the hospital. Thus, children sedated in the ED should not receive a significantly different level of attention or monitoring than children sedated for a comparable procedure in the operating room or in the GI laboratory. To ensure this, the JCAHO required each institution to develop protocols for sedation that would apply consistently throughout the institution. To assist in developing such policies, many hospitals have logically turned to the NIH and AAP guidelines. As specific language from these guidelines found its way into institutional policies (most notably the term "conscious sedation"), various specialty organizations struggled with how best to apply this language into the context of their specific practice settings.
In 1992 the AAP updated their original document.5 Multiple organizations, including ACEP,6 chose to independently develop their own set of sedation guidelines rather than endorse those proposed by the NIH and AAP.7-13 (See Table 1.) As anesthesiologists were increasingly called upon to assist in the development of such hospital-wide sedation policies, the ASA also chose to develop its own set of guidelines rather than embrace those already in existence.14
The multiple sets of sedation guidelines, to no one’s surprise, differ in many ways. Controversy has ensued as to which set of guidelines is most appropriate, with almost predictable allegations by the writers of more conservative guidelines that any perceived as less restrictive compromise patient safety.2,15 In this article, the three sets of guidelines most applicable to pediatric emergency medicine (AAP, ACEP, and ASA) will be contrasted and discussed.
What is a Standard? What is a Guideline?
A clear distinction must be made between standards and guidelines, as most of the discussion in this article refers to the latter. The JCAHO has defined a standard as "a statement of expectation that defines the structures and processes that must be substantially in place in an organization to enhance the quality of care."8 Thus, standards are essentially absolute rules (e.g., generally accepted minimum requirements for sound practice). Deviation from standards is not typically permissible and might be expected to result in an adverse opinion in a peer review process.
In contrast, the JCAHO defines guidelines as "descriptive tools or standardized specification for care of the typical patient in the typical situation, developed through a formal process that incorporates the best scientific evidence of effectiveness with expert opinion."8 Guidelines are intended to leave room for interpretation and flexibility. It is expected that physicians will periodically find just cause to deviate from guidelines, and that adverse opinion in a peer review process would not be automatic.
The ASA, for example, qualifies their sedation guidelines as follows: "These recommendations may be adopted, modified, exceeded, or rejected according to clinical needs and constraints, and they are subject to periodic revision as warranted by the evolution of medical knowledge, technology, and practice. Practice guidelines are not intended as standards or absolute requirements, and their use cannot guarantee any specific outcome."14
Every medical staff must be cautious when drafting sedation policies as, once approved, these may become "standards" within the institution. The JCAHO will be interested in an institution’s policies, fulfilling its role to make sure the policies guide appropriate medical care and meet the JCAHO standards. However, far fewer institutions have problems formulating a policy than documenting compliance with a policy. Thus, the JCAHO will be most interested in whether or not documentation supports compliance with the institution’s own policies. If a policy is approved that exceeds JCAHO minimum requirements, it is still possible to receive a negative citation from the JCAHO if the medical staff does not comply, by its documentation, with the policy. Most at risk for this will be the Medical Staff, which has written an unduly restrictive policy not permitting sufficient flexibility in clinical practice.
Definitions. The progression from mild sedation or analgesia to general anesthesia represents an even continuum that does not lend itself well to division into arbitrary stages. Low doses of narcotics or benzodiazepines induce mild analgesia or sedation, respectively, with little danger of adverse events. If, however, clinicians continue administering additional medication beyond this initial level, progressively altered consciousness ensues with a proportionately increased risk of respiratory and airway complications. If further medications are administered, the patient will continue to advance along this sedation continuum until protective airway reflexes are lost and general anesthesia is ultimately reached.
This sedation continuum is not drug-specific, in that varying states from mild sedation to general anesthesia can be achieved with almost all sedating agents (e.g., narcotics, benzodiazepines, barbiturates, propofol). Accordingly, most guidelines have been developed based upon the degree of sedation created rather than the specific pharmacologic agent used.
NIH and AAP’s "Conscious Sedation" vs. "Deep Sedation." In the original 1985 NIH and AAP guidelines, the terms "conscious sedation" and "deep sedation" were born3,4 and have been retained by the AAP in their 1992 guideline revision.5 (See Table 2.) By definition, "consciously" sedated children retain enough awareness of their surroundings to respond appropriately to verbal or physical stimuli. The example cited by the AAP is that children will open their eyes upon command. "Deeply" sedated children, however, will have their level of consciousness depressed to the point where such "appropriate" responses to external stimuli no longer occur.
The high profile of the NIH and AAP’s guidelines have made the term "conscious sedation" commonplace. This term has worked its way into hospital policies nationwide and as a sample policy in the JCAHO manual.8 Since the AAP guidelines stipulate that monitoring for deep sedation is virtually identical to that of general anesthesia, there has been a tremendous incentive for pediatric emergency practitioners to perform only conscious sedation for the vast majority of ED procedures, such that monitoring and personnel requirements are less stringent.16
The Myth of Conscious Sedation? More recently, however, the concept of conscious sedation has been criticized as a clinically unrealistic "myth."16 Can painful or frightening procedures truly be performed on children who are awake enough to respond "appropriately" to external stimuli? Certainly many minor procedures are amenable to this level of sedation (e.g., an older child with a shallow laceration in whom effective local anesthesia can be achieved). Other common ED indications are far less likely to be successful at this degree of sedation,15 including complex laceration repair, abscess incision and drainage, fracture reduction, and sexual assault examination. Maxwell and Yaster state, "We believe that the level of sedation required for most painful procedures in children is deep sedation."16 In actual clinical practice, when clinicians administer conscious sedation that does not allow comfortable completion of the procedure for the child, they are no doubt tempted to administer additional medication and temporarily "stray" into deep sedation territory. How frequently existing guidelines are "pushed" is uncertain.
ACEP’s "Sedation." Perhaps in response to this difficulty with truly "conscious" sedation, when ACEP released their 1994 guidelines6 they excluded the disputed term altogether. (See Tables 2 and 3.) Their corresponding term "sedation" was similar to the AAP’s conscious sedation state in requiring a stable respiratory and cardiovascular status; however, it differed in that "appropriate" responses to external stimuli were no longer required.
ACEP’s "less restrictive" definition allows a slightly deeper level of sedation to be achieved than AAP’s, as long as there remain "stable vital signs, an independent airway, and adequate spontaneous respirations." Thus, the ACEP definition provides the clinician more latitude in degree of sedation and allows performance of more painful or disturbing procedures (e.g., fracture reduction) that would likely be difficult or impossible using AAP’s conscious sedation alone.
Technically it is hard to argue with ACEP’s definition, as complications will not occur if airway, respiratory, and cardiovascular stability are intact. Vital signs and respiratory effort can be continuously assessed by careful observation and mechanical devices; however, the ability to identify when a child begins losing protective airway reflexes is less clear cut. Although unusual, emesis could occur at any time during sedation, and aspiration of gastric contents is a potentially fatal complication that must be aggressively prevented. The AAP’s stipulation of "appropriate" response to external stimuli is essentially a surrogate marker for airway stability, in that a child conscious enough to respond would typically have adequate protective airway reflexes. The degree to which a more heavily sedated child retains protective airway reflexes is unknown and will likely vary from individual to individual.
ASA’s "Sedation/Analgesia." In 1996, the ASA released their set of guidelines. In this document, the ASA also rejected the term "conscious sedation," labeling it as "imprecise."14 (See Table 3.) They replaced this term with the more generic descriptor "sedation/analgesia."
The definition of sedation/analgesia presented in Table 2 is essentially a compromise between the AAP and ACEP viewpoints. The key difference between the AAP and ASA definitions is that the AAP requires an "appropriate" response to physical or verbal stimulation, while the ASA requires only a "purposeful" response. For example, a sedated child who "purposefully" reaches to deflect a source of painful stimulus (e.g., local anesthetic injection) yet cannot open eyes to command meets the ASA definition of sedation/analgesia but would fall into deep sedation by AAP criteria.
Thus, when providing sedation/analgesia according to ASA guidelines the clinician must be able to differentiate a purposeful response from a reflex withdrawal to pain. Instead of providing an example of what would qualify for this state (as did the AAP with "open your eyes"), the ASA instead provided an example of the next sedation state: "Note that patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by sedation/analgesia."
Differentiating the States. The difference between the AAP’s conscious sedation, ACEP’s sedation, and ASA’s sedation/analgesia can also be thought of in terms of the Glasgow Coma Scale (GCS), though none of the organizations interpret their guidelines in this fashion. The lowest GCS reasonably compatible with conscious sedation, for example, would be 13. (See Table 4.) For sedation/analgesia, the lowest GCS could be reasonably interpreted as 9. Since sedation does not stipulate LOC, it is conceivable (but unlikely) that patients with a GCS of 8 or even lower would qualify, assuming the clinician had evidence of a stable airway and vital signs.
The AAP and ASA guidelines differ from ACEP in that they specify a surrogate marker for intact airway reflexes and respiratory drive (i.e., the requirement of an "appropriate" or "purposeful" response to external stimuli). Whether this surrogate marker reflects a reliable approximation of the limits of the airway-intact sedation continuum is uncertain. There is no research to verify whether clinicians can indeed push sedation beyond these surrogate markers while ensuring consistent retention of protective airway reflexes and respiratory drive.
A brief description of the guidelines available as of 1997 follows below. Some of these are comprehensive in nature, while others focus upon specific aspects of sedation.
National Institutes of Health (NIH) Guidelines, 1985.3 These original guidelines are entitled "Anesthesia and Sedation in the Dental Office," and set forth the original definitions for conscious sedation, deep sedation, and general anesthesia. The NIH guidelines are dated in that they are specifically oriented toward office procedures, and pulse oximetry is not required or recommended in all patients. Despite their historical importance, these guidelines have never been subsequently revised by the NIH. Perhaps, by default, they have chosen to leave the ongoing sedation controversy to the various specialty societies.
American Academy of Pediatrics (AAP) Guidelines, 1985; revised 1992. Unlike the NIH, the AAP revised their original 1985 guidelines in 1992,4,5 retaining the basic operational terms "conscious sedation" and "deep sedation." The new guidelines added pulse oximetry, removed the three person requirement for deep sedation, and eliminated the curious requirement of a precordial stethoscope for all sedation states.
The AAP guidelines are broad in scope and are intended for all children regardless of practitioner specialty, location, or procedure. They encompass sedation states, equipment, monitoring, and recovery.
The AAP guidelines provide a strong caution for non-fasting, emergency patients: "When proper fasting has not been assured, the increased risks of sedation must be carefully weighed against its benefits, and the lightest effective sedation should be used. An emergency patient may require protection of the airway before sedation."5
British Society of Gastroenterology Guidelines, 1991.9 These guidelines focus on both adult and pediatric endoscopic patients. The authors have purposely avoided defining sedation states or endorsing those of NIH and AAP, and suggest a single level of monitoring for all endoscopic sedation regardless of depth. Interestingly, these guidelines largely disclaim physician responsibility for the identification and management of sedation complications. Specifically, they state that "it is recognized that the endoscopist’s attention may be focused on the procedure. Where no other medically qualified practitioner is clinically monitoring the patient, the onus for this rests with the qualified nurse." Accordingly, the nurse must be "adequately trained in resuscitation techniques;" however, there is no such resuscitation training required for the physician.
Agency for Health Care Policy and Research (AHCPR) Guidelines, 1992.7 These guidelines discuss the full spectrum of acute pain management in both children and adults, including a brief discussion of procedural sedation. They refer in general terms to the value of a second practitioner dedicated to monitoring, serial vital sign measurement, pulse oximetry, and the immediate availability of resuscitation equipment and a practitioner skilled in advanced life support.
American Academy of Pediatric Dentistry (AAPD) Guidelines, 1993.10 These guidelines are very similar to the AAP guidelines but are focused on elective dental procedures and include an expanded discussion on nitrous oxide.
Emergency Nurses Association (ENA) Guidelines, 1993.11 This position statement affirms that monitoring of sedated adults and children is within the scope of practice of emergency nurses. Emphasis is placed upon avoiding additional responsibilities that might impede optimal patient monitoring. This document focuses upon the nursing role in sedation only.
American College of Critical Care Medicine (ACCM) Guidelines, 1995.12 This practice parameter focuses on the selection and administration of individual drugs used in the sedation of adult intubated ICU patients and has little relevance to the ED setting.
American College of Emergency Physicians (ACEP) Guidelines, 1995.6 The ACEP guidelines differ from those of the AAP in that the term "conscious sedation" is omitted and replaced with a more generic and "less restrictive" term "sedation."6
ACEP described the AAP guidelines as "not entirely applicable to emergency medicine," with one example being less restrictive language regarding oral intake prior to sedation: "Unlike scheduled procedures, those performed in the ED are not prearranged; therefore, fasting, pretreatment, or other preparatory activities may not be possible. This lack of preprocedure activities should not be considered a contraindication to the use of sedation and/or analgesia in the ED." Since the state sedation retains protective airway reflexes, ACEP appears to judge that the actual risk of aspiration in the ED setting is less than that implied in the AAP document.
Also in 1995, ACEP published a booklet entitled "Guidelines for Pediatric Sedation."17 In distinction to the official ACEP guidelines, this monograph provides an example of how one institution (Children’s Hospital, Boston) has interpreted published guidelines and implemented an ED sedation policy. It also provides a sample ED sedation flow sheet, discharge instructions, and a systematic description of various agents used for sedation and analgesia.
American Nurses Association (ANA) Guidelines, 1996.13 This position statement affirms that the monitoring of sedated adults and children is within the scope of practice of nurses. It is stipulated that the nurse "shall have no other responsibilities that would leave the patient unattended or compromise continuous monitoring." Requirements are listed for periodic vital signs, pulse oximetry, and immediately available expertise and equipment for resuscitation. This document focuses upon the nursing role in sedation only.
American Society of Anesthesiologists (ASA) Guidelines, 1996.14 In 1996, the ASA released their document, entitled "Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists." The Society performed a comprehensive literature review, rated studies with regard to methodological soundness, ranked degrees of confidence in various conclusions, and synthesized these data with the opinions of "a panel of more than 60 consultants, drawn from a variety of medical specialties in which sedation and analgesia are commonly provided."14
Using this evidence-based orientation, the ASA was unable to find literature support for many aspects of sedation put forth in other guidelines. In comparison with AAP, for example, the ASA guidelines are in some ways less restrictive, such as the definition of sedation/analgesia, preprocedure fasting, and level of monitoring. IVs, ECG monitoring, and supplemental oxygen are not required except in special circumstances.
Guidelines for monitoring as recommended for various sedation states are shown in Table 5. Yealy18 has divided monitoring into interactive and mechanical methods. Interactive monitoring refers specifically to the direct observation of the patient by a health care professional. Mechanical monitoring refers to the use of adjunctive devices to facilitate evaluation of the patient’s cardiopulmonary status.
Interactive Monitoring. Finally, an area on which the multiple guidelines all agree. The absolutely most important element of sedation monitoring is close and continuous observation of the patient by an individual capable of recognizing sedation complications. Respiratory depression and apnea can usually be identified promptly with visual inspection, and such careful, continuous observation will allow prompt detection and appropriate intervention for emesis, hypersalivation, airway malpositioning, etc.
The individual performing the monitoring should be able to continuously observe the face and mouth to ensure airway patency. This may involve careful arrangement of sterile drapes, if used, or their omission on the face altogether. The observer must also be able to easily observe chest wall motion to assess respiratory effort.
The multiple guidelines are also unanimous in that the observing practitioner cannot be the individual performing the indicated procedure, for obvious reasons of clinical focus. The level of training of the second practitioner is not stipulated; only that "the individual responsible for monitoring the patient should be trained in the recognition of complications associated with sedation/analgesia."14 Specific training in pediatric life support is "preferred."5,6 A registered nurse would seem logical for this role in most ED settings, although an EMT or ED assistant might substitute in some circumstances, given special training. If regular ED nurses are used for this monitoring, there is no special training or inservices stipulated, although certainly this is desirable.
Thus, ED sedation requires a minimum of two persons, one to perform the procedure and one to perform the interactive monitoring. The ASA guidelines allow that the monitoring practitioner "may assist with minor, interruptible tasks," and the AAP and ACEP guidelines do not forbid this minor assistance for conscious sedation or sedation.
The AAP’s deep sedation, however, is different. Assisting the individual performing the procedure is forbidden, and interactive monitoring must be the second practitioner’s "only responsibility" (besides the documentation of pulse oximetry, heart rate, respiratory rate, and blood pressure every 5 minutes). The original 1985 AAP guidelines required a third individual to be present to assist the actual procedure; however, the 1992 revision omitted this requirement, apparently to allow for procedures which do not require such assistance.
Mechanical Monitoring. Techniques of mechanical monitoring include vital sign measurements, pulse oximetry, ECG monitoring, and automated blood pressure devices. These techniques augment but do not replace interactive monitoring.18
Pulse oximetry has revolutionized mechanical monitoring. The ability of this device to rapidly identify changes in oxygen saturation allows detection of respiratory depression earlier than could be possible with clinical observation alone.1,14 This monitor also continuously displays heart rate. For safety reasons, it would seem difficult to justify omission of this simple, non-invasive intervention with any sedation technique other than simple analgesia.
ECG monitoring was standard before the advent of pulse oximetry, and its use has been carried forward more out of tradition than apparent necessity. Indeed, after careful literature review the ASA concluded that "ECG monitoring is not required in patients without cardiovascular disease." However, such monitoring is also simple and inexpensive and should be considered if more advanced levels of sedation are anticipated.
Periodic measurement of respiratory rate and blood pressure also make sense, as most sedating agents can induce both respiratory depression and hypotension. Except for AAP’s deep sedation, which requires documentation of vital signs every 5 minutes, the frequency with which vital signs must be recorded may be individualized for the unique circumstances of each case. According to the ASA, "at a minimum, this should be: 1) before the beginning of the procedure, 2) after administration of sedative/analgesic agents, 3) on completion of the procedure, 4) during initial recovery, and 5) at the time of discharge."14
The AAP, ACEP, and ASA are all in general agreement about most other aspects of sedation.
Preprocedure Evaluation. In all but the most emergent situations, sedation should be preceded by a directed history and physical examination. As summarized by the ASA: "Clinicians administering sedation/analgesia should be familiar with relevant aspects of the patient’s medical history including: 1) abnormalities of the major organ systems, 2) previous adverse experience with sedation/analgesia, 3) current medications, drug allergies, 4) time and nature of last oral intake, and 5) history of tobacco, alcohol, or substance use or abuse. Patients presenting for sedation/analgesia should undergo a focused physical examination including auscultation of the heart and lungs and evaluation of the airway."14 The purpose of the airway evaluation is to identify patients in whom advanced airway management might prove difficult (e.g., severe obesity, short neck, trismus). The presence of such an abnormality might lead a physician to reconsider the advisability of sedation in a given case.
A common method of preprocedure risk stratification is the "ASA Class."19 (See Table 6.) Anesthesiologists routinely use this scale to grade patients before any anesthesia or sedation. Although subjective, this scale may assist practitioners in assessing the potential level of risk with a planned sedation. ASA class 1 and 2 patients generally tolerate sedation without difficulty; however, patients at higher class levels have progressively increased sedation risk and may not be appropriate candidates for such sedation. Whenever possible, higher risk cases are better managed in the more controlled environment of an OR.
Parental Counseling and Consent. Except in emergency situations, the risks, benefits, and limitations of any procedural sedation should be discussed with the parent or guardian in advance, and their verbal agreement should be obtained.
Preprocedure Fasting. The ACEP guidelines state: "Unlike scheduled procedures, those performed in the ED are not prearranged; therefore, fasting, pretreatment, or other preparatory activities may not be possible. This lack of preprocedure activities should not be considered a contraindication to the use of sedation and/or analgesia in the ED."6
Information about prior oral intake should be obtained and balanced with the urgency of the procedure at hand. A small snack or beverage two hours before presentation, for example, should not preclude repair of a simple but dirty hand laceration. Delaying irrigation and repair of this wound significantly increases the risk of infection, and the depth of sedation needed should be low enough to entail a minimal risk of impaired airway reflexes. On the other hand, prompt sedation would be unwise for removal of a plastic bead lodged in a child’s external auditory canal if he or she had just eaten a burger, fries, and milk shake 30 minutes before. A delay of 2-4 hours would add a substantially higher margin of safety for this semi-elective procedure.
After completion of their literature review, the ASA concluded, "the literature provides insufficient data to test the hypothesis that preprocedure fasting results in a decreased incidence of adverse outcomes in patients undergoing sedation/analgesia. In urgent, emergent, or other situations when gastric emptying is impaired, the potential for pulmonary aspiration of gastric contents must be considered in determining the timing of the intervention and the degree of sedation/analgesia."14
Personnel. As stated by the ASA, "individuals responsible for patients receiving sedation/analgesia should understand the pharmacology of the agents that are administered, as well as the role of pharmacologic antagonists for opioids and benzodiazepines. Individuals monitoring patients receiving sedation/analgesia should be able to recognize the associated complications. At least one individual capable of establishing a patent airway and positive pressure ventilation . . . should be present whenever sedation/analgesia is administered. It is recommended that an individual with advanced life-support skills be immediately available."14
Application of this guideline to the ED setting would require a minimum of two persons: First, the individual (typically a nurse) performing the interactive monitoring who is capable of recognizing potential complications, and second, the individual (typically a trained emergency physician or pediatrician) overseeing drug administration, performing the procedure, and capable of advanced airway management if necessary. If the physician, for some reason, could not promptly be freed from the procedure to attend to potential complications (probably rare for ED procedures), then a second qualified individual should be available to attend to any adverse events during sedation.
Equipment. The sedation area should include all necessary equipment for advanced airway management and resuscitation, including oxygen, suction, and drug reversal agents (i.e., naloxone, flumazenil). A defibrillator should be available for subjects with significant cardiovascular disease.14
Supplemental Oxygen. Supplemental oxygen is not required in most cases of sedation but should be available if hypoxemia is anticipated or develops during sedation.14
Titration. For narcotics and benzodiazepines, IV titration through small, spaced, incremental doses permits the safest achievement of the desired level of sedation.14
IV Access. IV access is not required but is desirable to facilitate titration for most cases of sedation. According to the ASA, "In those situations when sedation is begun by non-IV routes (e.g., oral, rectal, IM), the need for IV access is not sufficiently addressed in the literature."14 It makes sense, however, for an individual skilled in starting IVs to be immediately available, as is typical in the ED.
Recovery Care. All patients receiving sedation should have the same level of both interactive and mechanical monitoring continued until they are no longer at risk for cardiorespiratory depression. Sample discharge criteria stipulate that "patients should be alert and oriented; infants and patients whose mental status was initially abnormal should have returned to their baseline," and "vital signs should be stable and within acceptable limits."14 Upon discharge, it should be ensured that a reliable adult will observe each child for post-procedure complications, and written instructions for this adult on diet, medications, and activities are ideal.14
Sedation agents include benzodiazepines (e.g., midazolam, lorazepam, diazepam), narcotics (e.g., fentanyl, meperidine, morphine), barbiturates (e.g., thiopental, methohexital, pentobarbital), chloral hydrate, propofol, and ketamine. Published guidelines typically do not provide specific directives for individual drugs (ACEP is the notable exception) but instead focus on the state of sedation produced. This makes sense, as the majority of these agents can in varying dosages induce the full continuum from light sedation or analgesia to complete general anesthesia. Physicians must carefully individualize their choice of agents to the specific needs for a given procedure. Certain drugs, such as chloral hydrate, have a well-established minimal risk of respiratory depression. Others, such as propofol, are more difficult to titrate than most, with a high likelihood of inadvertent deep sedation or even general anesthesia.1
Despite widespread use of multiple agents for pediatric sedation over the past decade, it is interesting to note that only two drugs are officially approved by the FDA for pediatric procedural sedation: parenteral midazolam and the oral "lollipop" form of fentanyl.2 Apparently for cost reasons, pharmaceutical companies are unwilling to sponsor the necessary research to validate the safety of individual drugs for this indication.1
What About Ketamine? Ketamine has become increasingly popular as a pediatric procedural sedation agent in the ED.6,20-24 Ketamine is technically easy to administer (usually IM or IV), does not require endotracheal intubation, and reliably produces potent analgesia, sedation, and amnesia.6,20,21,25-27 Procedural conditions are fully adequate in 90% or more of children sedated with ketamine,20,24 while success rates with narcotics and/or benzodiazepines may be substantially lower, especially when given IM.24
The unique features of ketamine prevent its classification according to existing guidelines. As patients receiving ketamine maintain spontaneous breathing and protective airway reflexes without intubation,6,22,25,26 this drug violates the NIH and AAP definitions of general anesthesia, which require "loss of protective reflexes, including the inability to maintain a patent airway."3,5 Similarly, ketamine does not meet corresponding definitions for either conscious sedation (which requires responsiveness) or deep sedation (which requires depressed airway reflexes and/or inability to maintain an airway).3,5 The state induced by ketamine is fundamentally unique both pharmacologically and clinically, and a fourth distinct category (e.g., the dissociative state) would appear both necessary and appropriate.
The low rate of complications described with ketamine20,21,24-27 suggests that guidelines similar to those specified for conscious sedation are adequate for dissociative sedation.
Interactive monitoring is extremely important when administering ketamine. Careful attention must be paid to airway positioning, as the patient may occasionally move his or her head with resulting partial airway obstruction. Hypersalivation may develop, especially if concurrent atropine is not given.20,21,25-27
Mechanical monitoring is less important with ketamine than with other sedating agents. Pulse oximetry is still mandatory, of course. However, since the dissociative state is characterized by consistent cardiovascular and respiratory stability, the need for regular documentation of blood pressure and heart rate is unnecessary. Certainly, a requirement of vital signs every five minutes (if one chooses to apply AAP’s deep sedation guidelines) appears excessive with ketamine.
Writing a Hospital-Wide Sedation Policy
In accordance with its "one level of quality of care" philosophy,8 the JCAHO has mandated that each hospital develop protocols for sedation regardless of the nature, duration, patient history, and location of the procedure. Emergency physicians and pediatricians should work together with designated individuals from their medical staff to ensure that hospital-wide sedation policies are clinically appropriate, evidence-based, and address all JCAHO standards. It must be emphasized that JCAHO directives are standards, not guidelines, and that once a hospital-wide sedation policy is in place, it effectively becomes a standard for JCAHO accreditation purposes within that institution. Thus, it must be assured that the document is not unrealistic, as once such a policy is approved, the JCAHO will expect it to be rigidly enforced.
The actual standards set forth by the JCAHO in regards to procedural sedation provide more flexibility than some may suppose. The standards from the 1997 JCAHO manual relating to procedural sedation are shown in Table 7.8 The JCAHO manual also includes examples of how their standards might be enacted. These examples are not, in and of themselves, standards, but are given as specific examples of forms of compliance acceptable to the JCAHO.
Which Set of Guidelines to Follow? The NIH and AAP terms "conscious sedation" and "deep sedation" only appear in one place in the JCAHO manualin a sample policy for procedural sedation. This should not be misinterpreted as an official endorsement of these specific guidelines, as this example is intended only to "illustrate one organization’s approach to developing definitions and protocols."8 The NIH and AAP documents were the only major guidelines available when this portion of the manual was written, and it is natural that the JCAHO example was based upon them. There should be no reason, however, why an alternative set of high-quality, evidence-based guidelines would not be equally acceptable, as long as the standards identified by the JCAHO are addressed.
The ACEP guidelines were developed specifically for ED patients and may not transpose easily into a hospital-wide policy. The ASA guidelines, however, are global in scope and were written with the JCAHO in mind. Since anesthesiologists typically chair the task forces developing these policies, it is also more likely that the ASA guidelines will be readily embraced by the task force than those by alternative specialty societies.
Writing the Policy. The sample policy provided by the JCAHO is naturally a reasonable place to start as a template. If the ASA guidelines are preferred to the NIH and AAP guidelines used in the example, then definitions of specific sedation states and levels of monitoring can be modified accordingly.
A major consideration when drafting a policy is when to expand beyond JCAHO mandates and when to keep things as simple as possible. There may be a tendency for task forces to introduce more complexity than may be warranted, such as complicated recovery scoring systems or anesthesia jargon not readily understood outside of the OR. A common hospital strategy is to attempt to "impress" the JCAHO through overcompliance. Despite the good intentions of this approach, there is a real risk that unduly complicated and lengthy policies written with this philosophy may not be read, understood, and therefore complied with by individual physicians. At the actual JCAHO visit, the surveyors will be just as interested in whether a hospital-wide policy is complied with and enforced as they may be in its content.
ED Sedation Must be Identical to OR Sedation. The JCAHO standard is that the level of sedation care provided in the ED must be "comparable" to that provided in the OR. "Comparable" does not necessarily mean "identical," and thus practices in the two hospital areas may differ to the degree that the global standard of care is not compromised and the variance is reasonable.
The Anesthesiology Department has Absolute Authority to Determine Sedation Practices. The sample sedation policy in the 1997 JCAHO manual contains the statement, "IV conscious sedation practices throughout the organization shall be monitored and evaluated by the Department of Anesthesia, according to the policy outlined and performed to assure optimal patient outcome."8 This example has been incorrectly interpreted by some as a JCAHO mandate.2
In reality, the specialty of the physician charged with developing such policy is not stipulated by the JCAHO. It is logical, however, to have an anesthesiologist chair such a task force or be otherwise integrally involved in such policy development. Anesthesiologists have a wealth of experience and perspective to offer in terms of the pharmacology, physiology, and clinical management of patients receiving sedation. Since anesthesiologists may not be entirely familiar with sedation practices outside of the OR, it is important to complement their leadership with the unique perspectives of other specialists skilled in sedation.
Physicians Must Undergo Special "Credentialing" to Administer Sedation. Some hospitals have instituted mandatory credentialing programs for procedural sedation. Physicians must apply for such privileges and, in some cases, then be proctored before they may independently administer sedation.
Such credentialing methods are not mentioned or even insinuated in the JCAHO manual, and thus accreditation should not be used to justify the initiation of such a policy. A number of hospitals have chosen to institute such policies, and the proliferation of this concept has led many to believe that failure to endorse this approach may be risky during a JCAHO review. In reality, each hospital must determine whether such credentialing meets its specific needs based upon the practice patterns and training of its medical staff. Current emergency medicine residencies and pediatric emergency medicine fellowships provide extensive training in procedural sedation, and the need for additional credentialing is unnecessary for such graduates. However, if hospitals choose to rely upon physicians with less experience and training, such a policy restricting sedation privileges may be both appropriate and necessary for optimal patient care.
Amidst the many conflicting sedation guidelines available, those published by the AAP, ACEP, and ASA are most applicable to pediatric emergency medicine. The ASA document is most likely to emerge as the dominant guideline, because it is global in nature and specifically oriented toward JCAHO requirements. Emergency physicians and pediatricians should work together with their anesthesiology colleagues to enact hospital-wide procedural sedation policies that are medically sound, evidence-based, and not unduly cumbersome. In this manner the very best in sedation care will be provided to the children we treat.
References
1. Cote CJ. Sedation for the pediatric patientA review. Pediatr Clin North Am 1994;41:31-59.
2. Cote CJ. Sedation protocolsWhy so many variations? Pediatrics 1994;94:281-283.
3. National Institutes of Health. Consensus conferenceAnesthesia and sedation in the dental office. JAMA 1985;8:1073-1076.
4. American Academy of Pediatrics Committee on Drugs. Guidelines for the elective use of conscious sedation, deep sedation, and general anesthesia in pediatric patients. Pediatrics 1985;76:317-321.
5. American Academy of Pediatrics Committee on Drugs. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics 1992; 89:1110-1115.
6. Sacchetti A, Schafermeyer R, Gerardi M, et al. Pediatric analgesia and sedation. Ann Emerg Med 1994;23:237-250.
7. US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research, Acute Pain Management Guideline Panel. Clinical practice guidelineAcute pain management: Operative or medical procedures and trauma. February 1992.
8. 1997 Accreditation Manual for Hospitals. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations, 1997.
9. Bell GD, McCloy RF, Charlton JE, et al. Recommendations for standards of sedation and patient monitoring during gastrointestinal endoscopy. Gut 1991;32:823.
10. American Academy of Pediatric Dentistry. Guidelines for the elective use of pharmacologic conscious sedation and deep sedation in pediatric dental patients. Pediatric Dentistry 1993;15:297-301.
11. Emergency Nurses Association. Conscious Sedation Position Statement. Park Ridge, IL: Emergency Nurses Association; 1992.
12. Shapiro BA, Warren J, Egol AB, et al. Practice parameters for intravenous analgesia and sedation for adult patients in the intensive care unitAn executive summary. Crit Care Med 1995;23:1596-1600.
13. American Nurses Association. The role of the registered nurse in the management of patients receiving IV conscious sedation for short-term therapeutic, diagnostic, or surgical procedures. Washington DC: American Nurses Association; 1996.
14. American Society of Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 1996; 84:459-471.
15. Algren JT, Algren CL. Sedation and analgesia for minor pediatric procedures. Pediatr Emerg Care 1996;12:435-441.
16. Maxwell LG, Yaster M. The myth of conscious sedation. Arch Pediatr Adolesc Med 1996;150:665-666.
17. Krauss BS, Shannon M, Damian FJ, et al. Guidelines for Pediatric Sedation. Dallas: American College of Emergency Physicians; 1995.
18. Yealy DM. Systemic analgesia and sedation for procedures in adults. In: Tintinalli JE, Ruiz E, Krome RL, editors. Emergency MedicineA Comprehensive Study Guide, Fourth Edition. New York: McGraw-Hill; 1996:234-237.
19. Dripps RD, Lamong A, Eckenhoff JE. The role of anesthesia in surgical mortality. JAMA 1961;178:261-266.
20. Green SM, Nakamura R, Johnson NE. Ketamine sedation for pediatric procedures: Part 1, A prospective series. Ann Emerg Med 1990; 19:1024-1032.
21. Green SM, Johnson NE. Ketamine sedation for pediatric procedures: Part 2, Review and implications. Ann Emerg Med 1990;19:1033-1046.
22. Pruitt JW, Goldwasser MS, Sabol SR, et al. Intramuscular ketamine, midazolam, and glycopyrrolate for pediatric sedation in the emergency department. J Oral Maxillofac Surg 1995;53:13-17.
23. Qureshi F, Mellis PT, McFadden MA. Efficacy of oral ketamine for providing sedation and analgesia to children requiring laceration repair. Pediatr Emerg Care 1995;11:93-97.
24. Petrack EM, Marx CM, Wright MS. Intramuscular ketamine is superior to meperidine, promethazine, and chlorpromazine for pediatric emergency department sedation. Arch Pediatr Adolesc Med 1996; 150:676-681.
25. White PF, Way WL, Trevor AJ. KetamineIts pharmacology and therapeutic uses. Anesthesiology 1982;56:119-136.
26. Corssen G, Reves JG, Stanley TH. Intravenous anesthesia and analgesia. Philadelphia: Lea & Febiger; 1988:99-174.
27. Reich DL, Silvay G. Ketamine: An update on the first twenty-five years of clinical experience. Can J Anaesth 1989;36:186-197.
Physician CME Questions
1. The earliest consensus documents on sedation:
a. were proposed by the Joint Commission on Accreditation of Healthcare Organizations.
b. represent an evidence-based recommendation of the American Society of Anesthesiologists.
c. dealt with dental patients and children.
d. have become standards for use in hospitals today.
e. are accepted as applicable to Pediatric Emergency Medicine by the American Academy of Pediatrics and the American College of Emergency Physicians.
2. The term "conscious sedation:"
a. is defined by the Joint Commission on Accreditation of Healthcare Organizations for appropriate use in hospitals.
b. is used the same way in guidelines generated by the American Academy of Pediatrics and the American College of Emergency Physicians.
c. is defined by the American Society of Anesthesiologists. Is applicable to ketamine.
d. is used in a JCAHO manual within an example of a sedation policy.
3. The American Society of Anesthesiologists have generated guidelines that:
a. require preprocedure fasting before administration of sedation.
b. require an ECG to be obtained prior to sedation.
c. require continuous cardiac monitoring during sedation.
d. require the presence of two medical personnel.
e. require the recording of heart rate and respiratory rate every five minutes.
4. In writing a sedation policy for a hospital environment, keep in mind which the following JCAHO requirement:
a. the level of care in the emergency department is identical to the operating room.
b. all patients are to receive a preanesthesia assessment.
c. the monitoring methods chosen to follow vital signs will be uniform and independent of the patient's medical condition.
d. the written policy must be approved by the Department of Anesthesia.
e. the written policy should include a credentialing process for physicians who utilize sedation techniques.
5. The American Society of Anesthesiology, the American Academy of Pediatrics and the American College of Emergency Physicians have generated guidelines for sedation which agree all of the following are requirements except:
a. blood pressure is to be recorded periodically.
b. more than one practitioner is needed.
c. close and continuous interactive monitoring is required.
d. pulse oximetry should be attached.
e. an intravenous line must be established.
6. During a JCAHO visit, site surveyors are likely to be most interested in:
a. how the medical staff documents compliance with sedation policies of the institution.
b. how the medical staff worked to develop policies on sedation.
c. how the institution's policies for sedation exceed the JCAHO requirements.
d. how the institution's policies for sedation are identical for various care areas.
e. how the Department of Anesthesia monitors sedation throughout the institution.
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