Adverse sedation events in pediatrics: A critical incident analysis of contributing factors

Objective. Factors that contribute to adverse sedation events in children u ndergoing procedures were examined using the technique of critical incident analysis. Methodology. We developed a database that consists of descriptions of adver se 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 fact ors that may have contributed to the adverse sedation event. The outcome, r anging in severity from death to no harm, was noted. Individual reports wer e first examined separately by 4 physicians trained in pediatric anesthesio logy, pediatric critical care medicine, or pediatric emergency medicine. On ly 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 f actors, 51 resulted in death, 9 in permanent neurologic injury, 21 in prolo nged hospitalization without injury, and in 14 there was no harm. Patients receiving sedation in nonhospital-based settings compared with hospital-bas ed settings were older and healthier. The venue of sedation was not associa ted with the incidence of presenting respiratory events leg, desaturation, apnea, laryngospasm, similar to 80% in each venue) but more cardiac arrests occurred as the second (53.6% vs 14%) and third events (25% vs 7%) in nonh ospital-based facilities. Inadequate resuscitation was rated as being a det erminant of adverse outcome more frequently in nonhospital-based events (57 .1% vs 2.3%). Death and permanent neurologic injury occurred more frequentl y in nonhospital-based facilities (92.8% vs 37.2%). Successful outcome (pro longed hospitalization without injury or no harm) was associated with the u se of pulse oximetry compared with a lack of any documented monitoring that was associated with unsuccessful outcome (death or permanent neurologic in jury). In addition, pulse oximetry monitoring of patients sedated in hospit als was uniformly associated with successful outcomes whereas in the nonhos pital-based venue, 4 out of 5 suffered adverse outcomes. Adverse outcomes d espite the benefit of an early warning regarding oxygenation likely reflect lack of skill in assessment and in the use of appropriate interventions, i e, a failure to rescue the patient. Conclusions. This study-a critical incident analysis-identifies several fea tures associated with adverse sedation events and poor outcome. There were differences in outcomes for venue: adverse outcomes (permanent neurologic i njury or death) occurred more frequently in a nonhospital-based facility, w hereas successful outcomes (prolonged hospitalization or no harm) occurred more frequently in a hospital-based setting. Inadequate resuscitation was m ore often associated with a nonhospital-based setting. Inadequate and incon sistent physiologic monitoring (particularly failure to use or respond appr opriately 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, medicatio n errors, and inadequate recovery procedures. Uniform, specialty-independen t guidelines for monitoring children during and after sedation are essentia l. Age and size-appropriate equipment and medications for resuscitation sho uld be immediately available regardless of the location where the child is sedated. All health care providers who sedate children, regardless of pract ice venue, should have advanced airway assessment and management training a nd be skilled in the resuscitation of infants and children so that they can successfully rescue their patient should an adverse sedation event occur.