Objectives: To determine the characteristics of children who met the risk criteria for potential neurotoxicity defined by the US Food and Drug Administration (FDA; 2016 warning) in a procedural sedation (PS) service. Study design: A single-center retrospective review of all infants and children aged <3 years receiving PS outside the operating room from 2014 to 2016. Demographics, duration of, and the reason for PS were analyzed. Results: A total of 2950 patients with 3653 sedation encounters were included. Median age was 19 (range, 11–26) months. Most PS (86.4%) were for magnetic resonance imaging (MRI). The median number of sedation procedures per patient was 1 (25th–75th: 1–7), and median duration of sedation was 72 minutes (25th–75th: 55–98 minutes). Forty patients (1.4%) required prolonged sedations >3 hours, in a single encounter (median, [25th–75th] of 196 minutes [185–214 minutes]), and 298 patients (10.1%) had multiple sedation exposures during the study period. Overall, 327 patients, 11.1% (95% confidence interval, 10.0%–12.3%) required repeated and/or prolonged sedation. The most common reasons for repeated or prolonged sedation were MRI of the brain and neurologic concerns. Conclusions: Multiple and prolonged PS commonly occurs outside the operating room in this young and potentially vulnerable population. Although certain imaging cannot be avoided, other cases may have the potential to be delayed until the child is >3 years old or to have alternate imaging that may not require prolonged PS. Family and provider awareness of the FDA warnings regarding potential neurotoxicity of sedation in all settings, both inside and outside the operating room, is critical.
- drug safety
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health