Fallah Razieh, Alaei Ali, Akhavan Karbasi Sedighah, Shajari Ahmad
Department of Pediatrics, Growth Disorders of Children Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Indian J Pediatr. 2014 Jun;81(6):541-6. doi: 10.1007/s12098-013-1298-y. Epub 2014 Jan 21.
To compare efficacy and safety of chloral hydrate (CH), chloral hydrate and promethazine (CH + P) and chloral hydrate and hydroxyzine (CH + H) in electroencephalography (EEG) sedation.
In a parallel single-blinded randomized clinical trial, ninety 1-7 y-old uncooperative kids who were referred to Pediatric Neurology Clinic of Shahid Sadoughi University, Yazd, Iran from April through August 2012, were randomly assigned to receive 40 mg/kg of chloral hydrate or 40 mg/kg of chloral hydrate and 1 mg/kg of promethazine or 40 mg/kg of chloral hydrate and 2 mg/kg of hydroxyzine. The primary endpoint was efficacy in sufficient sedation (obtaining four Ramsay sedation score) and successful completion of EEG. Secondary endpoint was clinical adverse events.
Thirty nine girls (43.3 %) and 51 boys (56.7 %) with mean age of 3.34 ± 1.47 y were assessed. Sufficient sedation and completion of EEG were achieved in 70 % (N = 21) of chloral hydrate group, in 83.3 % (N = 25) of CH + H group and in 96.7 % (N = 29) of CH + P group (p = 0.02). Mild clinical adverse events including vomiting [16.7 % (N = 5) in CH, 6.7 % (N = 2) in CH + P, 6.7 % (N = 2) in CH + H], agitation in 3.3 % of CH + P (N = 1) group and mild transient hypotension in 3.3 % of CH + H (N = 1) group occurred. Safety of these three sedation regimens was not statistically significant different (p = 0.14).
Combination of chloral hydrate-antihistamines can be used as the most effective and safe sedation regimen in drug induced sleep electroencephalography of kids.
比较水合氯醛(CH)、水合氯醛与异丙嗪(CH + P)以及水合氯醛与羟嗪(CH + H)在脑电图(EEG)镇静中的疗效和安全性。
在一项平行单盲随机临床试验中,2012年4月至8月间转诊至伊朗亚兹德沙希德萨杜基大学儿科神经科诊所的90名1至7岁不合作儿童被随机分配接受40mg/kg水合氯醛、40mg/kg水合氯醛加1mg/kg异丙嗪或40mg/kg水合氯醛加2mg/kg羟嗪。主要终点是充分镇静(获得四级拉姆齐镇静评分)和成功完成脑电图检查的疗效。次要终点是临床不良事件。
评估了39名女孩(43.3%)和51名男孩(56.7%),平均年龄为3.34±1.47岁。水合氯醛组70%(N = 21)、CH + H组83.3%(N = 25)和CH + P组96.7%(N = 29)实现了充分镇静和脑电图检查完成(p = 0.02)。发生了轻度临床不良事件,包括呕吐[水合氯醛组16.7%(N = 5),CH + P组6.7%(N = 2),CH + H组6.7%(N = 2)],CH + P组3.3%(N = 1)出现躁动,CH + H组3.3%(N = 1)出现轻度短暂性低血压。这三种镇静方案的安全性在统计学上无显著差异(p = 0.14)。
水合氯醛与抗组胺药联合可作为儿童药物诱导睡眠脑电图检查中最有效和安全的镇静方案。