Children's Healthcare of Atlanta at Egleston, Ga (PP Kamat, C Sulton, CE McCracken, and HK Simon); Departments of Pediatrics, Division of Critical Care Medicine (PP Kamat),.
Children's Healthcare of Atlanta at Egleston, Ga (PP Kamat, C Sulton, CE McCracken, and HK Simon); Pediatrics and Emergency Medicine (C Sulton and HK Simon).
Acad Pediatr. 2019 Nov-Dec;19(8):978-984. doi: 10.1016/j.acap.2019.02.011. Epub 2019 Mar 8.
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.
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.
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.
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.
确定符合美国食品和药物管理局(FDA;2016 年警告)定义的潜在神经毒性风险标准的儿童在程序镇静(PS)服务中的特征。
对 2014 年至 2016 年期间在手术室外接受 PS 的所有<3 岁婴儿和儿童进行的单中心回顾性研究。分析了人口统计学、PS 持续时间和 PS 原因。
共纳入 2950 例患者,3653 例镇静发作。中位年龄为 19 个月(范围,11-26 个月)。大多数 PS(86.4%)用于磁共振成像(MRI)。每位患者的平均镇静程序数为 1 次(25-75%:1-7 次),平均镇静时间为 72 分钟(25-75%:55-98 分钟)。40 例(1.4%)患者在单次就诊中需要长时间镇静>3 小时(中位数,[25-75%]为 196 分钟[185-214 分钟]),298 例患者(10.1%)在研究期间接受了多次镇静。总体而言,327 例患者(11.1%[95%置信区间,10.0%-12.3%])需要重复和/或延长镇静。重复或延长镇静的最常见原因是脑 MRI 和神经问题。
在这个年轻且易受影响的人群中,多次和长时间的 PS 通常在手术室外进行。尽管某些成像无法避免,但其他情况可能会延迟到儿童>3 岁或使用其他成像方法,而这些方法可能不需要长时间的 PS。无论在手术室内外,都必须让家属和医护人员了解 FDA 关于镇静潜在神经毒性的警告。