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

Department of Molecular Biology, Princeton University, Princeton, New Jersey, United States
Pediatrics (Impact Factor: 5.47). 05/2000; 105(4 Pt 1):805-14. DOI: 10.1542/peds.105.4.805
Source: PubMed


Factors that contribute to adverse sedation events in children undergoing procedures were examined using the technique of critical incident analysis.
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.
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.
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.

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    • "It should also be safe with few adverse events. Respiratory depression is the most important risk and predictor of sedation-related morbidity and mortality.[21] "
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    • "The greater the PK/PD (pharmacokinetic and pharmacodynamic) differences between the applied drugs are, the sooner these disorders occur. Procedural sedation applied to children became initially widespread in emergency departments [7, 8]. A large number of complications and adverse events was observed in this group of patients (17.8% of cases) [9]. "
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    Przegląd Gastroenterologiczny 05/2014; 9(2):77-81. DOI:10.5114/pg.2014.42501 · 0.38 Impact Factor
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    • "Notably, 5% of all children did not return to baseline activity levels until the second day after the procedure. The adverse effects reported after discharge include motor imbalance (31%), gastrointestinal effects (23%), agitation (19%), and restlessness (14%) [18,19]. Accordingly, prolonged recovery and the high incidence of post-discharge adverse effects support the administration of as low a dose of CH as possible. "
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    ABSTRACT: Chloral hydrate (CH) is the primary agent most commonly used for pediatric sedation prior to diagnostic, therapeutic procedures. In the management of pediatric facial laceration, the initial dose of CH has to balance the need for adequate sedation against the need to minimize sedative complications. A retrospective review of medical records of 834 children who visited our emergency room for facial lacerations from August 2010 to September 2012 was conducted. They were divided into six groups on the basis of the initial dose of CH administered. Further, each group was compared with the standard group (70 to ≤80 mg/kg) with respect to sedation success, augmentation dose, failed sedation, time to procedure, and time of stay. With respect to the complication rate, only group 1 (range, 40 to ≤50 mg/kg) showed a significantly lower complication rate. In the case of all the other variables considered, there were no significant differences among any of the groups. An initial CH dose of 48±2 mg/kg does not negatively affect the success rate of sedation or the need for additional sedative during the primary closure of facial lacerations in pediatric patients. Further, lower doses reduce the incidences of adverse effects and do not delay procedure readiness. Therefore, 48±2 mg/kg of CH can be considered the optimal initial dose for pediatric sedation.
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