ONE of the dilemmas faced by any caregiver providing sedation or anesthesia is the question, When is it safe to send the child home? Most sedation guidelines suggest that the patient should be returned to their baseline status before discharge. In this issue of the Journal, Malviya et al. describe a simple but elegant means for assessing the street readiness of infants sedated with chloral hydrate. 1
One of the reasons that it has been so difficult to make sedation safe is the long-standing battle between specialties regarding definitions, drugs, monitoring, and qualifications. Organizations have modified definitions *or developed guidelines to fit the needs of their specialty. 2The first guideline for monitoring children sedated for diagnostic procedures was published by the American Academy of Pediatrics (AAP). 3Unfortunately, we adopted language from the National Institutes of Health regarding dental sedation, especially the misnomer “conscious sedation,” an oxymoron in the pediatric population. The AAP later revised the guideline. Pulse oximetry was required for all sedated children and a systematic approach similar to that used by anesthesiologists was developed, i.e. , proper fasting, informed consent, focused airway examination, medical and/or surgical history, family history, previous sedation experiences, recommended equipment and medications, proper monitoring and documentation during and after the procedure, and strict discharge criteria. 4During the following years, the American Society of Anesthesiologists (ASA) became involved with sedation safety, in part because the Joint Commission of Accreditation of Healthcare Organizations (JCAHO) modified their regulations in such a way that made departments of anesthesiology responsible for developing “within institution” sedation guidelines. In response to the JCAHO requirements, and with a strong emphasis on improving safety, the ASA established a task force that developed the guideline for sedation by nonanesthesiologists. 5The first ASA iteration succeeded in changing the terminology from the oxymoron “conscious sedation” to the more appropriate term “sedation/analgesia,” but it did not address deep sedation. In 2002, the ASA published revised sedation guidelines that address all depths of sedation. 6The ASA, working closely with JCAHO, also developed new language to describe the sedation process, †which was later incorporated by the JCAHO. ‡Now, three stages of sedation are described: minimal, moderate, and deep. Recently, the AAP adopted the ASA definitions for their sedation guidelines 7; now the AAP, ASA, and JCAHO are speaking the same language. In addition, the JCAHO introduced the essential concept of rescue, i.e. , the practitioner must have the skills to rescue should the patient progress to a deeper level of sedation than intended. The JCAHO has been our friend by forcing conformity in the sedation process and the required airway management skills throughout many institutions. Unfortunately, these regulations do not yet apply to private practitioners’ offices.
This Editorial View accompanies the following article: Malviya S, Voepel-Lewis T, Ludomirsky A, Marshall J, Tait AR: Can we improve the assessment of discharge readiness? A comparative study of observational and objective measures of depth of sedation in children. Anesthesiology 2004; 100:218–24.
Our specialty is uniquely positioned to improve the sedation process. Now that the language is uniform and the definitions are clear, it is time to examine safety concerns and to explore issues not addressed in any guidelines. What qualifications are needed to administer sedation? How do individuals gain credentials to administer sedation? What drugs have the best efficacy and safety profile? Several years ago, I had the good fortune to be granted access to the adverse medication reports associated with pediatric sedation accidents collected by the Food and Drug Administration. 8Sixty of 95 cases were associated with death or neurologic injury. Contributory factors included drug overdose, drug interactions (e.g. , opioid and benzodiazepine), inadequate monitoring, inadequate medical evaluation, premature discharge, inadequate resuscitation skills, and others. Barbiturates, opioids, benzodiazepines, and sedatives were equally represented, suggesting that one class of drugs did not seem to offer advantage over another. 9Adverse events were associated with intravenous, intramuscular, oral, rectal, nasal, and inhalational routes of administration. There was a significant association with death and neurologic injury when three or more sedating medications were administered. The majority of events presented with an adverse effect on respiration or oxygenation; however, a large fraction progressed to cardiac arrest, indicating the lack of skills to rescue the patient once a problem developed. Compared with a hospital-like setting, the incidence of death or neurologic injury was threefold higher in an office venue. Two children died in car seats before arriving at the healthcare facility. Ten others (nine who died or had neurologic injury) suffered the event in the automobile or at home after discharge. These patients had each received medications with long half-lives: chloral hydrate (the drug used in the Malviya et al. study), promethazine, chlorpromazine, and intramuscular pentobarbital. The majority of these adverse outcomes were clearly preventable, and it was not the drug or the route of administration, but rather the practitioner’s lack of rescue skills and inadequate recovery.
The current study has scientifically examined the important safety issue of discharge readiness after sedation with a long-acting drug. They compared their current hospital discharge criteria with a new sedation score (the University of Michigan Sedation Score), combined with a simple Modified Maintenance of Wakefulness score (infants had to be able to stay awake for at least 20 min while observed in a soporific environment). They showed that the use of discharge criteria based on these new scores of alertness ensured that more than 90% of children had returned to baseline, compared with only 55% of children assessed as street-ready according to their current hospital criteria. Malviya et al. show very clearly that chloral hydrate can result in prolonged sedation, even after the children reach currently used discharge criteria. In our outcomes study, some of the children died from falling asleep in a car seat with their head falling forward; because of the residual sedating medications, they were unable to spontaneously unobstruct their airway. 8The current study may represent a turning point in our specialty—a maturing process from looking beyond guidelines and regulations to placing scientific validity on processes that we previously could only assume to be the right thing to do.
The results of this study suggest that the population at greatest risk for prolonged sedation is infants and toddlers (those most likely to return home in a car seat). 1,8,9It would make sense to implement these new discharge criteria now . Because anesthesiologists are central to the development of “within institution” sedation policies, our specialty is in the perfect position to make this happen. Implementation will increase costs, which is why the target population should be focused. The period of observation will be longer (more nursing time [∼ $7.50/patient hour based on ∼ $30/h nurse salary, observing four patients simultaneously]), and the facility charge will be greater (∼ $150/h in my institution for phase II recovery observation). Also, finding a quiet venue for this soporific observation period requires more hospital space dedicated to sedation (renovation costs or, alternatively, use of intake areas for both intake and stepdown observation). We all must be proactive and very creative to find the space and resources to sedate children safely. Because a parent’s single greatest concern is his or her child’s safety, parent participation may be central to rapidly implementing this extended period of observation at a lower cost, provided the reason for “quiet time observation” is explained. It is very likely that such careful assessments of wakefulness will prevent adverse outcomes.
The medical profession, along with the insurance industry and hospital administrators, must progress to the next level to truly make sedation safe. The insurance industry must recognize that some children can be safely cared for only in the hospital setting and by anesthesiologists; they also must compensate us fairly for this service. Hospitals must recognize that developing the proper safety net is expensive in terms of personnel (extra nurses) and facilities (properly equipped sedation and recovery areas). In some hospitals, the administration may need to supplement the income of those in the anesthesiology department to facilitate coverage. Anesthesiologists in turn must recognize that we cannot be present for every patient who requires sedation, and that this process must be provided and supervised by other physicians, e.g. , emergency medicine or intensive care specialists who have advanced airway training. In other situations, trained advanced-practice nurses supervised by nonanesthesiologists may provide the sedation. Hospitals must support anesthesiologists’ efforts to educate and train these practitioners to do this safely. The current study has addressed one issue, but a number of questions remain to be investigated and clarified. When is it safe to discharge patients sedated with different classes of drugs? What are the safety implications when, as my postanesthesia care nurses describe, it often takes 2 to 4 h longer for the children sedated for magnetic resonance imaging to recover from sedation administered by sedation nurses compared with children anesthetized for the same procedure? What drugs are best for specific procedures? Should the use of certain drugs be restricted to anesthesiologists? Should nonanesthesiologists be taught how to safely use drugs traditionally used as general anesthetics (e.g. , propofol)? In times of economic restraint, should nonanesthesiologists with advanced airway training be allowed to bill for anesthesia services? How does the healthcare industry finance the costs of safe sedation? The problem is that far more procedures require sedation than anesthesiologists have the time or desire to cover. How do we as a specialty maintain our vital role in this process without strangling ourselves with so many sedations that we cannot possibly cover them all?
Our specialty has an amazing track record of examining process and improving safety. We have reduced anesthetic mortality tenfold, we have reduced medication errors, and we have been essential in developing the specialties of Intensive Care and Pain Medicine. Now it is time for our specialty to go beyond the turf battles described above and help develop the best practices for non-anesthesiologists who administer sedation. Through the JCAHO mandate, our specialty can help establish sedation committees that examine quality assurance issues, similar to a code committee. Anesthesiologists do not need to be the “sedation police,” but through the committee process (and with the imprimatur of the JCAHO regulations), we can help each hospital develop a commitment to evaluate and change the best practices for sedation. The current study has addressed one issue that could be pivotal in improving the safety of discharging infants sedated with long-acting medications. The simple use of the University of Michigan Sedation Scale and meeting the criteria of “Can the child stay awake for 20 min when undisturbed?” would be wonderfully easy assessments to perform. I applaud Malviya et al. for taking an interest in developing better and simple discharge criteria in an area of practice generally avoided by anesthesiologists. I challenge my anesthesiology colleagues to answer the many questions that remain.