November 2000

Adverse sedation events in pediatrics: Analysis of medications used for sedation.
Coté CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Pediatrics. 2000; In press

Adverse sedation events in pediatrics: A critical incident analysis of contributory factors.
Coté CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Pediatrics 2000; 105: 805-14

Commentary by Charles J. Coté, M.D.

[see abstract below]

1. Cases were distributed among a wide variety of practitioners and venues (dental, radiology, cardiology, oncology, emergency medicine, gastroenterology, audiology, gynecology, surgeon, pediatrician office).
2. As expected, 80 percent of the children presented with some compromise of respiration as the first event, e.g. apnea, respiratory arrest, desaturation.
3. Seventy-one cases had sufficient information as to identify whether the case was in a hospital-based facility (hospital, surgi-center, emergency department) or non-hospital-based facility (office, free standing imaging facility).
4. Outcomes of death and permanent neurologic injury were more frequent in patients cared for in non-hospital-based facilities even though these patients were generally older, weighed more, and were healthier (ie. had a lower ASA physical status).
5. Significantly more patients suffered cardiac arrest as the second or third event in non-hospital based venues suggesting that, in these venues, the individuals involved lacked the skills to correct the compromise in respirations caused by the sedating medications. THERE WAS A FAILURE TO RESCUE.
6. Inadequate monitoring was a major contributory factor. There was a strong positive relationship between successful outcome (no harm or prolonged hospital stay) in patients monitored with pulse oximetry and unsuccessful outcome (death or neurologic injury) in patients whose reports specifically stated that no monitoring was used.
7. The class of medication did not influence outcome. There was no statistical difference between opioids, benzodiazepines, barbiturates, or sedatives (phenothiazines, chloral hydrate).
8. The adverse outcomes were associated with all routes of administration (oral, nasal, rectal, intramuscular, inhalation, or intravenous).
9. Several events took place at home or in an automobile when drugs were administered at home without the safety net of skilled medical supervision. At least two cases involved doses of drugs generally considered safe (chloral hydrate 60 mg/kg), oral midazolam 0.5 mg/kg). It is likely that these children became sedated while in car seats, at which point their head flexed forward and obstructed the airway. THESE CASES EMPHASIZE THAT NO SEDATING MEDICATIONS SHOULD BE ADMINISTERED AT HOME.
10. Several events occurred following sedation by a technician, not a nurse, physician or dentist. THESE CASES EMPHASIZE THAT SKILLED MEDICAL SUPERVISION IS REQUIRED AND THAT NON-MEDICAL PERSONNEL SHOULD NOT ADMINISTER SEDATING MEDICATIONS.
11. Several deaths took place after discharge, and all were associated with medications that have long half-lives (chloral hydrate, phenothiazines, and IM barbiturates).
12. Drug overdose, drug-drug interactions (e.g. benzodiazepines and opioids) and dispensing errors were common. Lack of understanding of the pharmacology of a medication was also a contributing factor (e.g. not understanding that chest wall and glottic rigidity following opioid can be reversed with an antagonist or muscle relaxant or attempting "reversal" of chloral hydrate with naloxone).
13. Adverse outcomes were associated with the administration of three or more sedating medications.
14. Dental practitioners (including oral surgeons, pediatric dentists and dentists with unspecified training) were disproportionately represented; 29/32 dental cases had death or neurologic injury as the outcome.

The reason for bringing these papers to the attention of anesthesiologists is that we are often asked to help develop hospital sedation guidelines[3,4]. It would be unrealistic to expect an anesthesiologist to be present for every sedation in the hospital, and there is no reason for us to be there, but we should be consulted on the difficult cases and we need to advocate for proper training of other practitioners.

It is obvious that adverse outcomes relate less to the class of drug and more to the person using these drugs. Even a drug such as chloral hydrate, which is considered by most to be a very safe medication, can cause sufficient airway compromise as to result in injury. I have been asked many times if chloral hydrate sedation is considered so safe that these patients may be excluded from monitoring! Our data clearly demonstrate that no exceptions can be made. Now when you are asked to consult on guidelines, you have some science to show why we need guidelines. Now you can say, with scientific backup, why, regardless of who is administering the drug or in what venue, the physician, nurse, dentist needs to have the skills and training to manage the airway so as to rescue the patient. The other comment often stated when something goes wrong is to blame the patient, e.g., "I've been doing it this way for 10 years and this is the first time this has happened." Since adverse outcomes are rare and children are very resilient, one could have a lifetime of bad practice and "get away with it". That is why guidelines are important and why proper training should be mandatory [5,6].

Our papers did not mean to pick on dental specialists, although some have felt that this was the case. Rather, the data reflect what was reported. We collected the data without any prediction as to where it would take us and reported as objectively as possible what we observed and could all agree to. We do not know the numerator or denominator, so no incidence data can be interpreted. However, it is clear that no child should die from sedation for any procedure, especially such non-invasive procedures as radiologic or dental care.

One thing the each of us as independent practitioners can do is to be advocates for safety within our institutions and within our state governments. We need to push our states to require that dental practice and surgical/medical office practice standards be the same as practice standards for hospitals. Much as we often complain about the Joint Commission of Accreditation of Healthcare Organizations (JCAHO) inspections and review, the JCAHO has done a wonderful job of forcing hospitals to develop institutional monitoring guidelines. Initially the chief of anesthesia was made responsible, but more recent versions have made the anesthesiologist the consultant, as it should be. Unfortunately, the JCAHO does not have any authority in office practice, which therefore allows surgeons, medical practitioners, dental practitioners, etc a wide latitude of care. Many individual state dental, medical, and surgical practice laws are very lax in the requirements for office practice and inspection of these offices. We need to change this!

One further system issue that likely has contributed to this carnage is that most insurance companies are reluctant to reimburse for anesthesia services for radiologic or dental procedures for healthy children yet these papers clearly demonstrate that the majority of adverse outcomes occurred in ASA 1 and 2 patients. This lack of insurance coverage then forces these practitioners to become the anesthesiologist. My guess is that if the same insurance industry that paid for malpractice coverage also paid for healthcare reimbursement, i.e. it all came out of the same pot of gold, then the value of anesthesiology services would be recognized and properly compensated.

References:

1. Coté CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: Analysis of medications used for sedation. Pediatrics. 2000; In press
2. Coté CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C: Adverse sedation events in pediatrics: A critical incident analysis of contributory factors. Pediatrics M<2000; 105: 805-14 (see abstract below)
3. Committee on Drugs American Academy of Pediatrics: Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics 1992; 89: 1110-5 4.
4. Gross JB, Bailey PL, Caplan RA, Connis RT, Coté CJ, Davis FG, Epstein BS, Kapur PA, Zerwas JM, Zuccaro J, Jr.: Practice guidelines for sedation and analgesia by non- anesthesiologists: A report by the American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non- anesthesiologists. Anesthesiology 1996; 84: 459-71 5.
5. Coté CJ: Sedation protocols—why so many variations? Pediatrics 1994; 94: 281-3 6.
6. Coté CJ: Monitoring guidelines: do they make a difference? Am J Roentgenol. 1995; 165: 910-2

ABSTRACTS Adverse sedation events in pediatrics: Analysis of medications used for sedation AUTHORS: Coté CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. SOURCE: Pediatrics. 2000; In press ABSTRACT: Abstract not yet available Adverse sedation events in pediatrics: A critical incident analysis of contributory factors AUTHORS: Coté CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. SOURCE: Pediatrics 2000; 105: 805-14 ABSTRACT: OBJECTIVE: Factors that contribute to adverse sedation events in children undergoing procedures were examined using the technique of critical incident analysis. METHODOLOGY: We developed a database that consists of descriptions of adverse sedation events derived from the Food and Drug Administration's adverse drug event reporting system, from the US Pharmacopeia, and from a survey of pediatric specialists. One hundred eighteen reports were reviewed for factors that may have contributed to the adverse sedation event. The outcome, ranging in severity from death to no harm, was noted. Individual reports were first examined separately by 4 physicians trained in pediatric anesthesiology, pediatric critical care medicine, or pediatric emergency medicine. Only reports for which all 4 reviewers agreed on the contributing factors and outcome were included in the final analysis. RESULTS: Of the 95 incidents with consensus agreement on the contributing factors, 51 resulted in death, 9 in permanent neurologic injury, 21 in prolonged hospitalization without injury, and in 14 there was no harm. Patients receiving sedation in nonhospital-based settings compared with hospital-based settings were older and healthier. The venue of sedation was not associated with the incidence of presenting respiratory events (eg, desaturation, apnea, laryngospasm, approximately 80% in each venue) but more cardiac arrests occurred as the second (53.6% vs 14%) and third events (25% vs 7%) in nonhospital-based facilities. Inadequate resuscitation was rated as being a determinant of adverse outcome more frequently in nonhospital-based events (57.1% vs 2.3%). Death and permanent neurologic injury occurred more frequently in nonhospital-based facilities (92.8% vs 37.2%). Successful outcome (prolonged hospitalization without injury or no harm) was associated with the use of pulse oximetry compared with a lack of any documented monitoring that was associated with unsuccessful outcome (death or permanent neurologic injury). In addition, pulse oximetry monitoring of patients sedated in hospitals was uniformly associated with successful outcomes whereas in the nonhospital-based venue, 4 out of 5 suffered adverse outcomes. Adverse outcomes despite the benefit of an early warning regarding oxygenation likely reflect lack of skill in assessment and in the use of appropriate interventions, ie, a failure to rescue the patient. CONCLUSIONS: This study-a critical incident analysis-identifies several features associated with adverse sedation events and poor outcome. There were differences in outcomes for venue: adverse outcomes (permanent neurologic injury or death) occurred more frequently in a nonhospital-based facility, whereas successful outcomes (prolonged hospitalization or no harm) occurred more frequently in a hospital-based setting. Inadequate resuscitation was more often associated with a nonhospital-based setting. Inadequate and inconsistent physiologic monitoring (particularly failure to use or respond appropriately to pulse oximetry) was another major factor contributing to poor outcome in all venues. Other issues rated by the reviewers were: inadequate presedation medical evaluation, lack of an independent observer, medication errors, and inadequate recovery procedures. Uniform, specialty-independent guidelines for monitoring children during and after sedation are essential. Age and size-appropriate equipment and medications for resuscitation should be immediately available regardless of the location where the child is sedated. All health care providers who sedate children, regardless of practice venue, should have advanced airway assessment and management training and be skilled in the resuscitation of infants and children so that they can successfully rescue their patient should an adverse sedation event occur.