1234: Questioning the FDA warning: Propofol use in the pediatric population

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Critical Care Medicine


Introduction/Hypothesis: The FDA published a warning in 2016 against lengthy use of anesthetics or sedation in children younger than three years old. Addressing uncertainties about anesthetic use in pediatrics is vital; the warning may cause parents to postpone necessary procedures in children. Pediatric Intensive Care Unit (PICU) physicians at our institution have been using propofol sedations and sought to collect data to analyze the safety of propofol use in the at- risk population by evaluating the frequency and severity of adverse outcomes, and identifying associated patient variables.Methods: Retrospective chart review of patients younger than age 3 who underwent procedures in the PICU using propofol between June 2008-July 2016. Primary outcome was frequency and severity of adverse events associated with propofol administration. Adverse event was defined as unplanned intubation, unplanned admission, or hemodynamic instability requiring vasopressors. After obtaining patient demographics and clinical outcomes, descriptive analyses was conducted.Results: A total of 1,587 patients met the criteria of inclusion in the study. 59% were male and 41% were female, with a mean age of 23.53 months (SD = 13.05 months) and a mean weight of 11.57 kg (SD = 3.73 kg). The most common primary procedure performed was EGD, comprising 45%. 90% of patients had an ASA score of II, and 7% had a known egg allergy. The mean total dose of propofol was 7.32 mg/kg (SD = 3.51 mg/kg). There were eight adverse outcomes, yielding an adverse event percentage of 0.50%. In one patient undergoing EGD, the patient aspirated, resulting in unplanned admission; in the constellation of inadequate NPO status combined with reflux esophagitis. Additional complications noted were unplanned intubations, due to laryngospasm, elective intubation, laryngomalacia, and decreased oxygen saturation.Conclusions: Propofol has a pivotal role in allowing safe procedures for pediatric patients. Making informed decisions to prevent delay of treatment is crucial for patient safety. Unlike the FDA, an assessment of our data shows that only 0.50% of patients experienced an adverse outcome which supports our hypothesis that using propofol for sedation in patients age less than 3 is indeed safe to use.




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