Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia.
Ann Emerg Med. 2020 Jun;75(6):735-743. doi: 10.1016/j.annemergmed.2019.11.019. Epub 2020 Jan 24.
Intranasal fentanyl and inhaled nitrous oxide are increasingly combined to provide procedural sedation and analgesia in the pediatric emergency setting. This regimen is attractive because of its nonparenteral administration, but is associated with a higher incidence of vomiting than nitrous oxide alone. We seek to assess whether prophylactic oral ondansetron use could reduce the incidence of vomiting associated with intranasal fentanyl and nitrous oxide for procedural sedation compared with placebo.
This was a double-blind, randomized controlled trial of oral ondansetron versus placebo conducted at a single tertiary care pediatric emergency department. Children aged 3 to 18 years with planned sedation with intranasal fentanyl and nitrous oxide were randomized to receive oral ondansetron or placebo 30 to 60 minutes before nitrous oxide administration. The primary outcome was early vomiting associated with procedural sedation, defined as occurring during or up to 1 hour after nitrous oxide administration. Secondary outcomes included vomiting 1 to 24 hours after procedural sedation, procedural sedation duration, adverse events, and quality of sedation across the 2 groups.
We recruited 442 participants and 436 were included for analysis. There was no significant difference in the primary outcome, early vomiting associated with procedural sedation, between the groups: ondansetron 12% versus placebo 16%, with a difference in proportions of -4.6% (95% confidence interval -11% to 2.0%; P=.18). Most sedations were reported as optimal by treating clinicians (91%). Only 2 minor adverse events occurred, both in the placebo group.
Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.
鼻内芬太尼和吸入一氧化二氮越来越多地联合用于儿科急诊环境中的镇静和镇痛。这种方案具有非肠道给药的优势，但与单独使用一氧化二氮相比，其呕吐发生率更高。我们旨在评估与安慰剂相比，预防性口服昂丹司琼是否能降低鼻内芬太尼和一氧化二氮联合用于程序镇静时与呕吐相关的发生率。
这是一项在一家三级儿科急诊中心进行的、针对鼻内芬太尼和一氧化二氮的双盲、随机对照试验。纳入计划接受鼻内芬太尼和一氧化二氮镇静的 3 至 18 岁儿童，在给予一氧化二氮前 30 至 60 分钟随机接受口服昂丹司琼或安慰剂。主要结局是与程序镇静相关的早期呕吐，定义为发生在给予一氧化二氮期间或之后 1 小时内。次要结局包括程序镇静后 1 至 24 小时呕吐、程序镇静持续时间、两组的不良事件和镇静质量。
我们招募了 442 名参与者，其中 436 名被纳入分析。两组之间主要结局，即与程序镇静相关的早期呕吐，无显著差异：昂丹司琼组 12%，安慰剂组 16%，两组之间的比例差异为-4.6%（95%置信区间-11%至 2.0%；P=.18）。大多数镇静治疗临床医生认为是最佳的（91%）。只有 2 例轻微不良事件发生，均在安慰剂组。
口服昂丹司琼并不能显著减少鼻内芬太尼和吸入一氧化二氮联合使用时在程序镇静期间或之后不久的呕吐。
