Sedating children for diagnostic and therapeutic procedures has engendered debate both within and between the myriad of pediatric specialists who provide this service. In hospitals across the United States, there is little agreement as to which medications, techniques, practice settings, or even personnel should be involved in its delivery. Confounding any discussion of solutions to this quandary is the fact that there has been scant discussion as to what defines success (or best practice) in sedating children. Furthermore, few aspects of anesthesia practice lead to as much confusion over the exact role of the pediatric anesthesiologist. (It is interesting to note that when the New England Journal of Medicine published a review article on pediatric sedation, it was written by two emergency medicine physicians (1).) Perhaps now more than ever, reflection is required on the state of the art of pediatric sedation and the key areas where anesthesiologists can function to help optimize its safety and efficacy. In this review, we will seek to examine the past role of anesthesiologists in shaping the field of pediatric sedation, the current status of pediatric sedation as reflected by the literature, and goals for improving future practice.
The Historical Role of Anesthesiologists
Reports relating to specific involvement by anesthesiologists in pediatric sedation are rare before the early 1980s. Arguably, the most significant contribution of our specialty has been in the development of sedation guidelines, which subsequently became international standards. The first monitoring guideline for sedation was written by Dr. Charles Coté and Dr. Theodore Striker in 1983 (published in 1985) while working on behalf of the American Academy of Pediatrics (AAP) Section on Anesthesiology. This guideline was written in response to reports of three deaths in a single dental office and other concerns primarily involving dental sedation (2). Written with the cooperation of the American Academy of Pediatric Dentistry and the American Society of Anesthesiologists (ASA), the purpose of the guidelines was to develop a framework from which improved safety could be developed for children requiring sedation to perform a required procedure (3,4). The guideline emphasized systems issues, such as the need for informed consent, appropriate fasting before sedation, frequent measurement and charting of vital signs, the availability of age and size appropriate equipment, the use of physiologic monitoring, the need for basic life support skills, and proper recovery and discharge procedures. The concept of an independent observer whose only responsibility was to monitor the patient was introduced for deeply sedated pediatric patients. Advanced airway and resuscitation skills were encouraged but not required. Finally, these original guidelines defined three terms for depth of sedation: conscious sedation, deep sedation, and general anesthesia. The descriptive term conscious sedation was defined as, “A medically controlled state of depressed consciousness that allows the protective reflexes to be maintained; retains the patient’s ability to maintain a patent airway independently and continuously; and permits an appropriate response by the patient to physical stimulation or verbal command, e.g., ‘open your eyes’.” In retrospect, the choice of this terminology was unfortunate, because this condition is rarely attained in sedated children, and its use led to confusion and promoted practices that were not intended by the original guideline.
In 1992, the Committee on Drugs of the AAP (primary author Dr. Coté) revised the 1985 guideline (5). This new iteration clearly stated that a patient could readily progress from one level of sedation to another and that the practitioner should be prepared to increase vigilance and monitoring as indicated. Pulse oximetry was recommended for all patients undergoing sedation. This new guideline also discouraged the practice of administering sedation at home by parents—a practice that was not infrequent in dental and radiologic sedation at that time. An amendment to this guideline was produced by the same Committee on Drugs of the AAP 2002 (6). It eliminated the use of the term “conscious sedation” and clarified the fact that these guidelines apply to any location where children are sedated, including in or out of the hospital. The current guidelines use the terminology of minimal sedation, moderate sedation, deep sedation, and anesthesia. This language is consistent with that used by the ASA and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (7).
Contemporaneous with the guideline development described above, other organizations including the American Academy of Pediatric Dentistry and the American College of Emergency Physicians wrote their own guidelines for sedation (8,9). These guidelines were at odds with the AAP/ASA guidelines in some respects, perhaps most importantly in their definition of sedation levels themselves. The result has been considerable confusion when practitioners or regulatory requirements overlap. Whereas the situation will not be resolved quickly, the AAP guidelines are once again being revised, and dialogue with these organizations has been initiated toward the goal of a unified nomenclature and consistent recommendations for pediatric sedation.
Current Status Evaluation
It is difficult to fully comprehend the current status of pediatric sedation because the reports concerning this practice are published in such a wide range of journals, and the outcome measures used vary so greatly. What we do know is that each year, millions of infants and children require sedation and pain control for medical procedures. Hospitals and offices struggle with the logistical and medical difficulties associated with providing this service. There is often heavy demand for pediatric sedation services throughout the usual work day as well as off hours, and these cases must be performed in a wide variety of locations involving many different services, including radiology, dentistry, pediatric inpatient service, emergency department, and nuclear medicine. The difficulty in meeting these demands was pointed out in a study that found centers in the United States were much less likely to offer sedation for painful procedures than similar centers in Europe (10). Thirty percent of US respondents to this mail survey reported performing bone marrow biopsies in children without significant sedation more than 50% of the time as compared with 0% of European centers.
Attempts to accommodate the need for pediatric sedation have led to the formulation of a wide variety of possible solutions. Some sedation services have opted for direct physician involvement, whereas others are directed by trained nursing personnel (11–13). Still, others have developed the concept of a sedation room or a sedation team combining provider types (14–18).
When sedation is attempted for pediatric procedures, the reported efficacy of the various sedation system options differs considerably. The major goals of pediatric procedural sedation may vary with the specific procedure, but generally encompass anxiety relief, pain control, and control of excessive movement. The rate of failure to achieve these goals has been reported by various investigators to be as infrequent as 1%–3% (19–22) and by others to be as frequent as 10%–20% (23–28). Success rates not only depend on the setting (including the provider) and the type of procedure that is being performed, but also on the definition used for adequate or successful sedation. In most published studies, any sedation regimen that allows a procedure to be completed is counted as successful (29). We are rarely informed of the condition of the patient during the procedure or during the recovery period. In this way, a child who is given a dose of oral midazolam and cries or screams during a lumbar puncture and then sleeps for 2 h is considered an equal success as the patient who lies perfectly still under brief propofol sedation, although objective observers would clearly count one strategy a success and the other a failure.
When sedation fails, procedures are performed on children who are crying, struggling, and requiring significant restraint. This situation leads to unwanted stress in the child and family, adverse procedure outcomes, and care that is generally less effective (30).
Theroux et al. (27) described the common practice of suturing children who have lacerations without sedation using only local anesthesia and papoose boards to restrain noncompliant patients. As expected, adding sedation dramatically reduced crying and struggling and increased parental satisfaction. Similarly, Stokland et al. (31) documented decreased stress (and increased satisfaction) in a cohort of patients undergoing voiding cystourethrogram studies. Kain et al. (32) found inadequate preoperative sedation was clearly linked to anxiety in children and their families surrounding surgical procedures. Even more concerning, these investigators documented that 54% of children undergoing stressful anesthesia induction have postoperative maladaptive behaviors. Furthermore, they found that the incidence of these behaviors could be decreased through the use of appropriate sedation. Similar findings of post-traumatic stress syndrome have been documented in a population of children after hospitalization with repeated invasive procedures (33).
Diagnostic procedure quality suffers when suboptimal sedation leaves movement uncontrolled, particularly in radiology practice. Malviya et al. (34) have reported clear improvement in the quality of magnetic resonance imaging (MRI) scans performed using anesthesia as compared with moderate sedation. In addition, when movement is grossly excessive, procedures must often be rescheduled with an expert sedation service providing the sedation. This logically leads to significant increases in cost of the procedure because of lost time in the scanner and lost work time for care providers. Multiple centers report cancellation rates as much as 15% for radiological procedures (MRIs, CT scans, etc.) in children because of excessive movement (23,24,35). Rates of failure in this setting decrease dramatically when sedation is provided by a dedicated team, by implementing clear protocols (28,36), or when anesthesiologists provide sedation (37).
The manner in which length of duration of sedation matches the requirements for a procedure must also be considered in evaluating the success of a sedation technique. A case in point is the (still very) common use of chloral hydrate for CT scans or other brief procedures (26,38–40). Whereas many reports catalog successful completion of studies without injury to patients, one must ask whether 60–150 min of sedation is appropriate for a 5-min study. Perhaps even more important are the delayed side effects described by Malviya et al (41). These investigators found restlessness and agitation lasting more than 6 h in one-third of children undergoing neuroimaging with chloral hydrate sedation, 5% of whom did not return to their baseline activity for 2 days after their procedure. The financial implications of lost workdays for parents and return visits to emergency departments have never been fully considered in studies of long-acting sedatives used for brief procedures.
Pediatric sedation practice extends over a diverse group of medical specialties (anesthesiology, intensive care medicine, emergency medicine, and radiology) and provider types (registered nurse [RN], advanced registered nurse practitioner, certified registered nurse practitioner, physician assistant, and MD). Whereas this makes definitive statements about the direction of current practice difficult, we believe several trends are evident:
1. Propofol sedation delivered by nonanesthesiologists is a growing practice across the country. This is particularly true in the intensive care environment and the emergency department. Most of the literature regarding this practice is found in the intensive care literature, where the virtues of propofol’s rapid onset and recovery are extolled. A common model that is being promoted is that of the intensive care unit (ICU) sedation team headed by an intensivist using some portion of the pediatric ICU to run a pediatric sedation service (17,42–44). This practice is made more attractive by the fact that many of these practitioners can be credentialed in the hospital to deliver this care and will bill under anesthesia codes (45). Other models, such as the initiation of propofol sedation in the ICU and sending patients with RN monitors to other locations in the hospital have also been reported (14). Use in dentistry, oral surgery, endoscopy, and radiology has also been advocated by nonanesthesiologists (25,35,46–51). Two new studies describe the use of propofol for procedural sedation by emergency physicians (52,53). All of these reports are notable for the fact that they represent nonanesthesiologists informing other nonanesthesiologists on the proper technique for administering propofol. Their recommendations for use and treatment of minor side effects are not always in line with those of anesthesiologists (54).
2. Although it is certainly not a new drug, ketamine sedation has experienced a resurgence in popularity, particularly in the emergency department—if published studies and reports are any indication of practice. IM and IV ketamine (with and without midazolam) are favorite strategies for accomplishing closed fracture reductions and other painful minor procedures in this setting (19,55–63). Authors site the lack of respiratory depression and the maintenance of airway reflexes as great advantages for ketamine over other sedation options. Its effectiveness in producing adequate sedation for painful procedures is excellent. However, postsedation nausea and vomiting, emergence reactions, and infrequent episodes of laryngospasm continue to be cited (64–66) with its use. Leading proponents of the use of ketamine suggest that it should be considered in its own separate category of sedation—dissociative sedation—and that guidelines concerning its use should reflect this unique nature (67).
3. Led by emergency physicians, the applicability of nil per os (NPO) guidelines, which have been propagated for pediatric sedation as an extension of anesthesia practice, have been called into question (68–70). Although the largest prospective or retrospective studies involving this practice are still relatively small (1500 patients), the authors point out that there seems to be little evidence for patient harm. In addition, these investigators point out that there are no case reports of aspiration during pediatric sedation in the emergency department, regardless of NPO status. These studies drive home the fact that sedation of nonfasted children is commonplace in the emergency department setting, and publication of prospective data on the outcomes of this practice may ultimately impact thinking on this issue for elective sedation.
4. Finally, a review of the current literature reveals that specialists outside of anesthesiology continue to expand their repertoire of medications used for pediatric sedation to include those normally associated with general anesthesia, attaining depths of sedation that undoubtedly reach this level. The published literature outside of anesthesiology is replete with descriptive or randomized studies of small numbers of patients undergoing procedures with one deep sedation regimen or another (17,43,46,52,71,72). At the same time, reports of sedation experience and innovation are relatively rare in the anesthesia literature, probably because this work is considered so routine as to not be worthy of reporting. The result is the perception by other medical specialists that pediatric sedation is evolving into the domain of intensivists and emergency medicine specialists, where anesthesiologists are experts in the operating room domain.
Current Sedation Strategies
Pediatric sedation technique should ideally be customized for the patient and the procedure to be performed. For example, a distinction should be made as to whether the procedure will involve significant discomfort. Nonpainful procedures, such as MRI scans or nuclear scans, are best accomplished with a rapid acting pure sedative such as propofol. The effectiveness and smooth recovery characteristics of this drug are familiar to anesthesiologists and without peer for this application. Indeed it is the clear advantages of propofol that have caused nonanesthesiologists to gravitate toward its use, despite concerns about monitoring and airway management skills.
Alternatively, for painful procedures such as a bone marrow biopsy, procedural conditions are improved by the addition of an analgesic component such as a small dose of fentanyl, infusion of remifentanil, or the use of ketamine as a sedation adjunct. Additionally, patient factors, such as hemodynamic instability because of cardiomyopathy, make the choice of a drug such as etomidate preferable to propofol in some instances.
Finally, the personnel involved in monitoring and delivering pediatric sedation will influence the choice of sedation drug. When anesthesiologists are delivering sedation, any of the currently available sedative hypnotics and analgesics can be brought to bear on a given case. When a sedation system is configured with nurse providers, drugs with a very wide safety margin, such as chloral hydrate and pentobarbital, are usually selected. As mentioned above, the willingness and ability of nonanesthesiologist MDs to use potent sedative hypnotics is an area of evolution at this time, but the published trend is clearly toward expansion of the use of these drugs outside of anesthesiology (17,43,46,52,71,72).
With these caveats in mind, we have constructed Table 1(73–88) to represent some of the most common current strategies for sedation of children. This is not meant to be an all-inclusive listing, but rather it is a catalog of the most common medications for sedation based on literature review, discussion with colleagues, and personal experience.
Of course, any of the painful procedures mentioned could be accomplished through the use of potent inhaled anesthetics. There is one recent study (30) that showed improved satisfaction and procedural conditions when general anesthesia was used instead of midazolam for moderate sedation for painful oncology procedures. Whereas this is always an option, inhaled anesthesia, which requires the use of an anesthesia machine and appropriate scavenging equipment, can lead to undesired emergence phenomena (89). For the purposes of this review, we will focus on sedation delivered by other routes and include only nitrous oxide for inhalation.
Note: We have not included a discussion of local anesthetics; their use is very important for any procedural sedation provider. Appropriate application of local anesthesia may allow pure sedative use for an otherwise painful procedure because it may constitute the analgesic component of the sedation plan. Large doses of local anesthetics may have their own sedating effects and add to the sedation that is produced by other drugs and deepen the sedation level achieved.
Safety Issues in Pediatric Sedation
The safety of pediatric sedation practice has proven difficult, if not impossible, to assess with prospective studies. There are simply no large, sufficiently powered, multicentered trials to evaluate safety in this context. Instead, the literature is replete with descriptions of how sedative medications can be used in a variety of settings on a series of patients (usually less that 200 in a cohort) without a fatality (38,51,55,76,79,90). Given that the expected incidence of a sedation-induced crisis should be on the order of 1 in tens of thousands, it is not surprising that these studies rarely uncover a critical event. In fact, if a study were designed to detect a difference between one sedation method with a fatality rate of one in 5000 compared to another method with a fatality rate of one in 20,000, the study would require more than 50,000 patients in each group.
Efforts to detect safe or unsafe practice from epidemiological studies will require large cooperative databases that have the power to detect (what should be) rare events. Alternatively, techniques are required that will reveal much more detail of our current practice and investigate the potential impact (or lack of importance) of desaturation events or other minor complications.
Defining Safety in the Context of Pediatric Sedation
In addition to these statistical difficulties, we must define the nature of safety and what constitutes complications. Science has taught us that error and failure in complex systems can be thought of in terms of accomplishing the work goal and avoiding or managing side effects. The focus on sedation safety tends to be directed towards how often a sedative drug produces an unwanted side effect or toxicity. In this context, the most serious complication of pediatric procedural sedation, death, is most often caused by the unmanaged respiratory depressant side effect of sedative medications. Although an incidence of death or permanent neurological injury during pediatric sedation is impossible to calculate because of a lack of data, evaluation of the published literature on pediatric sedation indicates that these events are rare (29). However, sedation is a prevalent situation (millions of children receive sedation annually) (91). In their often-cited retrospective studies, Dr. Charles Coté et al. reviewed 95 cases of sedation-related deaths and critical incidents derived from the Food and Drug Administration’s adverse drug event reporting system from the US Pharmacopeia and from a survey of pediatric specialists (92,93). Their analysis revealed that (rather than being related to a specific medication) the overwhelming majority of critical events were preventable and caused by operator error or lack of robust rescue systems when incidents occurred. Whereas many of the incidents cited in this study occurred over 20 years ago, and therefore predated the implementation of AAP sedation guidelines, the findings in this study were similar to those in all high-risk fields and are likely applicable today. In fact, even when clinicians adhere to current practice guidelines for pediatric procedural sedation, there is risk of iatrogenic injury. One study prospectively followed 1140 children (age, 2.96 ± 3.7 yr) sedated for procedures by nonanesthesiologists following AAP guidelines and using a quality assurance tool. Approximately 13% of the children received inadequate sedation. They also reported a 5.3% incidence of respiratory events, including one in which a child stopped breathing (23).
Most prospective studies of sedation practice available at this time do little to clarify what is meant by safety in pediatric sedation. Authors will invariably cite the incidences of hypotension, hypoxia, and airway obstruction (and interventions required to reestablish normoxia or normotension). However, as long as no child is critically injured (or dies) during the study, the conclusions are that their technique is safe and effective (42,51,65,78,94). Despite the lack of patient injury or death, a detailed examination of the data from some of these studies calls these conclusions into question. Is the requirement to bag-mask 10% of patients and intubate 1% of patients consistent with a safe technique, or does this indicate that rescue systems in that institution are particularly robust? (43) Safety can only be implied for the setting in which these studies have taken place. In most cases, these are large teaching hospitals with copious and readily available assistance. In different settings with less robust rescue systems, the outcomes from these events could be much more concerning.
Sedation is not a primary therapy but rather a treatment of procedural side effects, such as pain, anxiety, and dangerous movement. Failure to treat these side effects with adequate sedation may help the provider avoid respiratory depression but results in accomplishing the procedure through physical restraint. As reviewed in the Outcomes section of this paper, whereas no child may die of their pain or stress during a procedure, the psychological injury that accompanies this type of error remains an unwanted (unsafe) outcome of the care provided. We remember the historical record of when surgery was performed before the invention of adequate anesthesia. In many instances, the psychological trauma was severe, and in many cases, patients refused required surgery. Whereas the psychological trauma associated with unsedated bone marrow aspiration, lumbar puncture, and urinary catheter placement on children has not been quantified, post-traumatic stress disorder has been well documented in children experiencing trauma in the hospital setting (95,96). In addition, it is logical that the safety of a given procedure may be compromised when the operative conditions are poor. For example, a thrashing, crying child receiving intrathecal chemotherapy is at increased risk for extradural injection. In this safety framework, we strongly advocate that sedation providers define as inadequate or failure any sedation that results in patients who are in severe distress during a procedure.
Human simulation offers an extremely promising technology in the promotion of pediatric sedation safety. As with other industries that face high-risk, infrequent events, simulators can be extremely helpful in recreating rare clinical situations and testing the response of individuals and systems to rescue patients who are in respiratory or cardiovascular arrest (97–99). At Dartmouth Hitchcock Medical Center, we have piloted the use of the pediatric simulator to test the response of sedation care providers to sedation emergencies in three different areas of our hospital. The resulting data revealed significant differences in the time it took for different care teams to recognize and rescue patients from apnea and hypoxia, varying from <2 min to more than 6 min (100).
In a more widespread application, human simulation is rapidly gaining popularity as a training tool for care providers in anesthesiology and other specialties (98,101,102). The use of this technology to train sedation providers to recognize critical airway emergencies and initiate resuscitation is already in place in several institutions (103). Future work will need to establish the validity of this type of training for pediatric sedation and refine realistic scenarios.
Future Direction for Pediatric Sedation
In considering the current status of pediatric sedation and the safety issues involved, the future can either be viewed as murky and disturbing or an opportunity to provide clarity through collaborative research and clinical program development. To begin, there is a need to better define the effectiveness and risks associated with the various pediatric sedation protocols that have been proposed in the last several years and will be proposed in the future. As is the case with anesthesia, large clinical trials or databases are required to sort out the frequency of critical events. Information collected from the various institutions and including providers from a multitude of pediatric specialties and practice settings would allow meaningful data analysis on which drugs are being used, how they are delivered, by whom, and with what kinds of outcomes.
Sedation vs. Anesthesia
The proliferation of the use of drug combinations including propofol with potent opiates by nonanesthesiologists in the future will continue to force us to examine the question as to where deep sedation ends and general anesthesia begins. According to the ASA/JCAHO/AAP criteria, the distinguishing characteristic between these two entities is the presence or absence of a response to repeated painful stimuli. Whereas most studies involving sedation do not describe the condition of sedated patients adequately enough to determine the sedation level of the patient, there is no doubt that many of the regimens used in emergency departments and ICUs around the country are evolving into recipes for brief general anesthesia rather than sedation. In light of the fact that the difference between these two states can be subtle (patients can go in and out of a given state quite rapidly) and that there is no practical way to police this practice, any effort to limit anesthesia by nonanesthesiologists for brief procedures in children is doomed to failure.
In terms of promoting safety and generally good sedation delivery, pediatric patients will be better served by advocating for standards anesthesiologists have successfully used to improve the safety of anesthesia care by 10-fold over the last 20 yr (104). Specifically, all providers of deep sedation (that is, everyone who sedates children for painful procedures) should be able to rescue patients from side effects of general anesthesia, as mandated by the JCAHO. To do this, anesthesiologists need to demand that high standards are met by these individuals. These should include, but not be limited to, the following: (a) There should be defined competencies in terms of airway management (i.e., effective bag-mask ventilation), and these skills should be demonstrated in clinical practice or simulation setting; (b) Knowledge of disease entities that impact sedation and anesthesia should be documented; (c) Familiarity with sedation drugs (doses, side effects, and contraindications), reversal drugs, and rescue medications should be documented; (d) Intraprocedural monitoring should mirror those for anesthesia, including optimal methods for monitoring ventilation (capnography) as well as oxygenation; (e) All equipment required for emergency interventions such as masks, airways, suction, and ventilation bags must be present for each sedation, and they must be regularly checked and accounted for; and (f) Sedation systems must have a quality improvement program that examines its own outcomes on a continuing basis.
The continued improvement of pediatric sedation practice depends on the involvement of qualified professionals. This involvement can only be guaranteed through proper reimbursement. Unfortunately, reimbursement depends on payer mix, private insurer commitment to sedation, and state medicaid reimbursement schedules. As such, there is no blanket answer to the problem of making pediatric sedation an attractive or practical pursuit. To assure reimbursement is appropriate, anesthesiologists need to lobby insurance companies and state agencies to assure that payment is appropriate for this critical service.
Providing sedation to children is an area of rapid change marked by evolving standards. Whereas anesthesiologists have played a critical role in establishing guidelines for safe sedation, considerable work remains in defining what represents effective and safe practice. The overwhelming demographic demand for pediatric sedation services has mandated that other pediatric specialists and nurses deliver a wide range of sedation outside the operating room. It is critical at this time that anesthesiologists use their established identity as the ultimate experts in this field with a proven track record of practice improvement to assure that clinical practice, training, and safety in this field is optimized.
The authors would like to thank Charles Coté, MD, for his help in compiling this review.
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