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PEDIATRICS Vol. 105 No. 4 April 2000, pp. 805-814

Adverse Sedation Events in Pediatrics: A Critical Incident Analysis of Contributing Factors

Received Jul 12, 1999; accepted Oct 7, 1999.

Charles J. Coté*, Daniel A. NottermanDagger , Helen W. Karl§, Joseph A. Weinbergparallel , and Carolyn McCloskey

From the * Department of Pediatric Anesthesiology, Children's Memorial Hospital, Northwestern University School of Medicine, Chicago, Illinois; the Dagger  Department of Molecular Biology, Princeton University, Princeton, New Jersey and the Division of Critical Care Medicine, New York Presbyterian Hospital, New York, New York; the § Department of Pediatric Anesthesiology, Children's Hospital, University of Washington School of Medicine, Seattle, Washington; the parallel  Department of Emergency Services, LeBonheur Children's Medical Center, Department of Pediatrics, University of Tennessee College of Medicine, Memphis, Tennessee; and  the Food and Drug Administration Center for Drug Evaluation and Research, Office of Post-Marketing Drug Risk Assessment, Division of Drug Risk Evaluation II, Washington, DC.

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, ~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.  Key words:  sedation, adverse events, critical incident, medication errors, monitoring, guidelines.




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