一项比较鼻内给予右美托咪定和吸入一氧化二氮用于儿童操作镇静和镇痛的随机临床试验。
A randomized clinical trial of intranasal dexmedetomidine versus inhaled nitrous oxide for procedural sedation and analgesia in children.
机构信息
Department of Emergency Medicine and Services, Helsinki University, University of Helsinki, P.O. Box, Helsinki, 00014, Finland.
Department of Emergency Care for Children Astrid Lindgren Children´s Hospital, Department of Women's and Children's Health Karolinska Institutet, Stockholm, 17176, Sweden.
出版信息
Scand J Trauma Resusc Emerg Med. 2024 Nov 20;32(1):117. doi: 10.1186/s13049-024-01292-0.
BACKGROUND
Procedural sedation and analgesia is an important part of pediatric emergency care, safe and clinically useful alternatives for adequate management are necessary. The objective of this clinical trial was to evaluate the non-inferiority of intranasal dexmedetomidine to nitrous oxide with respect to analgesia for a painful procedure in children 3-15 years of age.
METHODS
This prospective, equally randomized, open-label, non-inferiority trial was conducted at a Pediatric Emergency Department. Previously healthy children 3-15 years of age, with an extremity fracture or luxation or a burn and requiring procedural sedation and analgesia were eligible. Patients were randomized to receive either intranasal dexmedetomidine or inhaled nitrous oxide. The primary outcome measure was highest pain level during the procedure, assessed with Face, Legs, Activity, Cry, Consolability scale (FLACC). Mann-Whitney U test (continuous variables) and Fisher's test (categorical variables) were used for statistical analysis.
RESULTS
The highest FLACC was median 4 (IQR 3-6) with intranasal dexmedetomidine and median 4 (IQR 2-6) with nitrous oxide. The median of the difference between samples from each group for FLACC was 0 with 95%CI (0-1), thus intranasal dexmedetomidine was not inferior to nitrous oxide with respect to the level of pain during the procedure. The same method for procedural sedation and analgesia would be accepted by 52/74 (82.5%) children and 65/74 (91.5%) parents in the intranasal dexmedetomidine group respectively 59/74 (88.1%) versus 70/74 (94.6%) with nitrous oxide. No serious adverse events were reported.
CONCLUSIONS
The results of this trial support that intranasal dexmedetomidine is not inferior to 50% nitrous oxide in providing analgesia for a painful procedure in children 3-15 years of age and can be considered as an alternative to 50% nitrous oxide for procedural sedation and analgesia.
TRIAL REGISTRATION
EudraCT 201,600,377,317, April 20, 2017. https://eudract.ema.europa.eu/ .
背景
程序镇静和镇痛是儿科急救的重要组成部分，需要安全且具有临床意义的替代方法来进行充分的管理。本临床试验的目的是评估鼻内右美托咪定相对于儿童 3-15 岁疼痛性操作的镇痛效果不劣于笑气。
方法
这是一项前瞻性、随机、开放标签、非劣效性试验，在儿科急诊室进行。之前健康的 3-15 岁儿童，有四肢骨折或脱位或烧伤，需要程序镇静和镇痛，有资格参加。患者被随机分配接受鼻内右美托咪定或吸入笑气。主要结局指标是在操作过程中最高疼痛水平，采用面部、腿部、活动、哭泣、安慰评分（FLACC）进行评估。采用曼-惠特尼 U 检验（连续变量）和 Fisher 检验（分类变量）进行统计分析。
结果
鼻内右美托咪定的最高 FLACC 中位数为 4（IQR 3-6），吸入笑气的最高 FLACC 中位数为 4（IQR 2-6）。每组样本之间的差异中位数为 0，95%CI（0-1），因此，鼻内右美托咪定在操作过程中的疼痛水平上不劣于笑气。同样的方法用于程序镇静和镇痛，分别有 52/74（82.5%）的儿童和 65/74（91.5%）的父母会接受鼻内右美托咪定组，59/74（88.1%）的儿童和 70/74（94.6%）的父母会接受笑气组。没有报告严重不良事件。
结论
本试验结果支持鼻内右美托咪定在提供 3-15 岁儿童疼痛性操作的镇痛效果方面不劣于 50%笑气，可以作为 50%笑气用于程序镇静和镇痛的替代方法。
试验注册
EudraCT 201,600,377,317，2017 年 4 月 20 日，https://eudract.ema.europa.eu/。
Zotero 插件