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口服水合氯醛与鼻内右美托咪定加颊部咪达唑仑用于儿童听觉脑干反应测试的随机对照试验

A randomized controlled trial of oral chloral hydrate vs intranasal dexmedetomidine plus buccal midazolam for auditory brainstem response testing in children.

作者信息

Li Bi L, Yuen Vivian M, Zhou Jia L, Zhang Na, Huang Jun X, Tian Hang, Song Xing R

机构信息

Department of Anaesthesiology, Guangzhou Women and Children's Medical Centre, Guangzhou Medical University, Guangzhou, Guangdong, China.

Department of Anaesthesiology, Hong Kong Children's Hospital and Queen Mary Hospital, Hong Kong, Hong Kong.

出版信息

Paediatr Anaesth. 2018 Nov;28(11):1022-1028. doi: 10.1111/pan.13498. Epub 2018 Oct 3.

DOI:10.1111/pan.13498
PMID:30281180
Abstract

BACKGROUND

Moderate to deep sedation is required for an auditory brainstem response test when high-intensity stimulation is used. Chloral hydrate is the most commonly used sedative, whereas intranasal dexmedetomidine is increasingly used in pediatric non-painful procedural sedations.

OBJECTIVE

The aim of this study was to compare the sedation success rate after oral chloral hydrate at 50 mg kg and intranasal dexmedetomidine at 3 μg kg plus buccal midazolam at 0.1 mg kg for an auditory brainstem response test.

METHODS

Children who required an auditory brainstem response test were recruited and randomly assigned to receive oral chloral hydrate at 50 mg kg and intranasal placebo, or intranasal dexmedetomidine at 3 μg kg with buccal midazolam 0.1 mg kg . The primary outcome was the rate of successful sedation for auditory brainstem response tests.

RESULTS

Fifty-seven out of 82 (69.5%) were successfully sedated after chloral hydrate, while 70 out of 78 (89.7%) children were successfully sedated with dexmedetomidine plus midazolam combination, with the odd ratio (95% CI) for successful sedation between dexmedetomidine plus midazolam combination and chloral hydrate estimated to be 3.84 (1.61-9.16), P = 0.002. Dexmedetomidine plus midazolam was associated with quicker onset with median onset time 15 (IQR 11.0-19.8) for dexmedetomidine plus midazolam and 20 (IQR 15.0-27.0) for chloral hydrate respectively, with difference between median (95% CI) of 5 [3-8], P < 0.0001). The behavior observed during drug administration of intranasal dexmedetomidine and buccal midazolam was better that of the children who had oral chloral hydrate. No children required oxygen therapy or medical intervention for hemodynamic disturbances in this study and the incidence of hypotension and bradycardia was similar.

CONCLUSION

Intranasal dexmedetomidine plus buccal midazolam was associated with higher sedation success with deeper level of sedation, with similar discharge time and adverse event rate when compared to chloral hydrate.

摘要

背景

当使用高强度刺激进行听觉脑干反应测试时,需要进行中度至深度镇静。水合氯醛是最常用的镇静剂,而鼻内右美托咪定在儿科非疼痛性程序镇静中使用越来越多。

目的

本研究旨在比较口服50mg/kg水合氯醛、鼻内给予3μg/kg右美托咪定加0.1mg/kg颊部咪达唑仑用于听觉脑干反应测试后的镇静成功率。

方法

招募需要进行听觉脑干反应测试的儿童,并随机分配接受口服50mg/kg水合氯醛和鼻内安慰剂,或鼻内给予3μg/kg右美托咪定加0.1mg/kg颊部咪达唑仑。主要结局是听觉脑干反应测试的成功镇静率。

结果

水合氯醛组82例中有57例(69.5%)成功镇静,而右美托咪定加咪达唑仑联合组78例中有70例(89.7%)成功镇静,右美托咪定加咪达唑仑联合组与水合氯醛组成功镇静的比值比(95%CI)估计为3.84(1.61-9.16),P=0.002。右美托咪定加咪达唑仑起效更快,右美托咪定加咪达唑仑的中位起效时间为15(IQR 11.0-19.8),水合氯醛的中位起效时间为20(IQR 15.0-27.0),中位数(95%CI)差异为5[3-8],P<0.0001)。鼻内给予右美托咪定和颊部咪达唑仑给药期间观察到的行为比口服水合氯醛的儿童更好。本研究中没有儿童因血流动力学紊乱需要吸氧治疗或医疗干预,低血压和心动过缓的发生率相似。

结论

与水合氯醛相比,鼻内右美托咪定加颊部咪达唑仑镇静成功率更高,镇静程度更深,出院时间和不良事件发生率相似。

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