Razieh Fallah, Sharam Jalili, Motahhareh Golestan, Sedighah Akhavan Karbasi, Mohammad-Hosein Jarahzadeh
Department of Pediatrics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Iran J Pediatr. 2013 Feb;23(1):27-31.
The purpose of this study was to compare efficacy and safety of oral chloral hydrate (CH) and promethazine (PZ) for sedation during electroencephalography (EEG) in children.
In a parallel single-blinded randomized clinical trial, sixty 1-10 year old children referred to EEG Unit of Shahid Sadoughi Hospital from January 2010 to February 2011 in Yazd, Iran, were evaluated. They were randomized to receive orally 70 mg/kg chloral hydrate or promethazine 1 mg/kg. The primary outcome was efficacy in adequate sedation and successful recording of EEG. Secondary outcome included clinical side effects, time from administration of the drug to adequate sedation, caregiver's satisfaction on a Likert scale, and total stay time in EEG Unit.
Twenty four cases with mean age 2.9±1.9 years were evaluated. Adequate sedation (Ramsay sedation score of four) was obtained in 43.3% of PZ and 100% of CH group (P=0.00001). Also in 70% of PZ and 96.7% of CH group, EEG was successfully recorded (P=0.006). So, CH was a more effective drug. In CH group, EEG was performed in shorter time after taking the drug (32.82±9.6 vs 52.14±22.88 minutes, P<0.001) and the parents waited less in the EEG unit (1.29±0.54 vs 2.6±0.59 hours, P<0.001). They were also more satisfied (4.6±0.6 scores vs 3.1±1.4 scores, P=0.001). Mild side effects such as vomiting in 20% of CH (n = 6) and agitation in 6.6% of PZ group (n = 2) were seen. No significant difference was seen from viewpoint of side effects frequency between the two drugs.
The results of the present study showed that chloral hydrate can be considered as a safe and more effective drug in sedation induction for sleep EEG in children.
本研究旨在比较口服水合氯醛（CH）和异丙嗪（PZ）在儿童脑电图（EEG）检查期间镇静的疗效和安全性。
在一项平行单盲随机临床试验中，对2010年1月至2011年2月期间转诊至伊朗亚兹德沙希德萨杜基医院脑电图室的60名1 - 10岁儿童进行了评估。他们被随机分为口服70mg/kg水合氯醛组或1mg/kg异丙嗪组。主要结局是充分镇静的疗效以及脑电图的成功记录。次要结局包括临床副作用、从给药到充分镇静的时间、照顾者在李克特量表上的满意度以及在脑电图室的总停留时间。
对平均年龄为2.9±1.9岁的24例病例进行了评估。异丙嗪组43.3%和水合氯醛组100%获得了充分镇静（ Ramsay镇静评分4分）（P = 0.00001）。同样，异丙嗪组70%和水合氯醛组96.7%成功记录了脑电图（P = 0.006）。因此，水合氯醛是一种更有效的药物。在水合氯醛组，服药后进行脑电图检查的时间更短（32.82±9.6 vs 52.14±22.88分钟，P<0.001），父母在脑电图室等待的时间更少（1.29±0.54 vs 2.6±0.59小时，P<0.001）。他们也更满意（4.6±0.6分 vs 3.1±1.4分，P = 0.001）。观察到轻微副作用，如20%的水合氯醛组（n = 6）出现呕吐，6.6%的异丙嗪组（n = 2）出现躁动。从两种药物副作用频率的角度来看，没有观察到显著差异。
本研究结果表明，水合氯醛可被视为儿童睡眠脑电图镇静诱导中一种安全且更有效的药物。
