一项比较鼻内用右美托咪定与鼻内用依托咪酯用于小儿镇静镇痛的随机双盲试验。
A randomized double-blind trial of intranasal dexmedetomidine versus intranasal esketamine for procedural sedation and analgesia in young children.
机构信息
Department of Emergency Medicine and Services, Helsinki University, P.O. Box 4, 00014, Helsinki, Finland.
Department of Pediatric Anesthesia and Intensive Care, Astrid Lindgren Children's Hospital, Karolinska University Hospital, 171 76, Stockholm, Sweden.
出版信息
Scand J Trauma Resusc Emerg Med. 2024 Mar 4;32(1):16. doi: 10.1186/s13049-024-01190-5.
BACKGROUND
Procedural sedation and analgesia are commonly used in the Emergency Departments. Despite this common need, there is still a lack of options for adequate and safe analgesia and sedation in children. The objective of this study was to evaluate whether intranasal dexmedetomidine could provide more effective analgesia and sedation during a procedure than intranasal esketamine.
METHODS
This was a double-blind equally randomized (1:1) superiority trial of 30 children aged 1-3 years presenting to the Emergency Department with a laceration or a burn and requiring procedural sedation and analgesia. Patients were randomized to receive 2.0 mcg/kg intranasal dexmedetomidine or 1.0 mg/kg intranasal esketamine. The primary outcome measure was highest pain (assessed using Face, Legs, Activity, Cry, Consolability scale (FLACC)) during the procedure. Secondary outcomes were sedation depth, parents' satisfaction, and physician's assessment. Comparisons were done using Mann-Whitney U test (continuous variables) and Fisher's test (categorical variables).
RESULTS
Adequate analgesia and sedation were reached in 28/30 patients. The estimated sample size was not reached due to changes in treatment of minor injuries and logistical reasons. The median (IQR) of highest FLACC was 1 (0-3) with intranasal dexmedetomidine and 5 (2-6.75) with intranasal esketamine, (p-value 0.09). 85.7% of the parents with children treated with intranasal dexmedetomidine were "very satisfied" with the procedure and sedation compared to the 46.2% of those with intranasal esketamine, (p-value 0.1). No severe adverse events were reported during this trial.
CONCLUSIONS
This study was underpowered and did not show any difference between intranasal dexmedetomidine and intranasal esketamine for procedural sedation and analgesia in young children. However, the results support that intranasal dexmedetomidine could provide effective analgesia and sedation during procedures in young children aged 1-3 years with minor injuries.
TRIAL REGISTRATION
Eudra-CT 2017-00057-40, April 20, 2017. https://eudract.ema.europa.eu/.
背景
程序镇静和镇痛在急诊科中经常使用。尽管有这种普遍的需求，但儿童仍缺乏足够和安全的镇痛和镇静选择。本研究的目的是评估在进行程序时，鼻内给予右美托咪定是否比鼻内给予依托咪酯能提供更有效的镇痛和镇静。
方法
这是一项双盲、均衡随机（1:1）优效性试验，共纳入 30 名年龄在 1-3 岁的因撕裂伤或烧伤就诊于急诊科且需要进行程序镇静和镇痛的儿童。患者随机接受 2.0 mcg/kg 鼻内右美托咪定或 1.0 mg/kg 鼻内依托咪酯。主要结局测量指标是在操作过程中最高的疼痛（使用面部、腿部、活动、哭声、安慰性量表（FLACC）评估）。次要结局指标为镇静深度、家长满意度和医生评估。采用 Mann-Whitney U 检验（连续变量）和 Fisher 检验（分类变量）进行比较。
结果
28/30 例患者达到了足够的镇痛和镇静效果。由于治疗小创伤的变化和后勤原因，估计的样本量未达到。鼻内右美托咪定的中位数（IQR）为 1（0-3），鼻内依托咪酯为 5（2-6.75），（p 值为 0.09）。接受鼻内右美托咪定治疗的患儿的父母中，有 85.7%对手术和镇静非常满意，而接受鼻内依托咪酯治疗的患儿中，只有 46.2%的父母非常满意，（p 值为 0.1）。在这项试验中，没有报告严重的不良事件。
结论
本研究的效力不足，没有显示在 1-3 岁儿童的程序镇静和镇痛中，鼻内右美托咪定与鼻内依托咪酯之间有任何差异。然而，结果支持鼻内右美托咪定可在 1-3 岁有小创伤的儿童进行操作时提供有效镇痛和镇静。
试验注册
Eudra-CT 2017-00057-40，2017 年 4 月 20 日。https://eudract.ema.europa.eu/。
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