Fallah Razieh, Fadavi Nafiseh, Behdad Shekofah, Fallah Tafti Mahmoud
Growth Disorders of Children Research Center, Shahid Sadoughi University of Medical Sciences,Yazd, Iran ; Department of Pediatrics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Department of Pediatrics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Iran J Child Neurol. 2014 Spring;8(2):11-7.
Magnetic resonance imaging (MRI) is a useful diagnostic tool for the evaluation of congenital or acquired brain lesions. But, in all of less than 8-year-old children, pharmacological agents and procedural sedation should be used to induce motionless conditions for imaging studies. The purpose of this study was to compare the efficacy and safety of combination of chloral hydrate-hydroxyzine (CH+H) and chloral hydrate-midazolam (CH+M) in pediatric MRI sedation.
MATERIALS & METHODS: In a parallel single-blinded randomized clinical trial, sixty 1-7-year-old children who underwent brain MRI, were randomly assigned to receive chloral hydrate in a minimum dosage of 40 mg/kg in combination with either 2 mg/kg of hydroxyzine or 0.5 mg/kg of midazolam. The primary outcomes were efficacy of adequate sedation (Ramsay sedation score of five) and completion of MRI examination. The secondary outcome was clinical side-effects.
Twenty-eight girls (46.7%) and 32 boys (53.3%) with the mean age of 2.72±1.58 years were studied. Adequate sedation and completion of MRI were achieved in 76.7% of CH+H group. Mild and transient clinical side-effects, such as vomiting of one child in each group and agitation in 2 (6.6 %) children of CH+M group, were also seen. The adverse events were more frequent in CH+M group.
Combinations of chloral hydrate-hydroxyzine and chloral hydrate-midazolam were effective in pediatric MRI sedation; however, chloral hydrate-hydroxyzine was safer.
磁共振成像(MRI)是评估先天性或后天性脑损伤的一种有用的诊断工具。但是,对于所有8岁以下儿童,在进行影像学检查时应使用药物和程序镇静来诱导静止状态。本研究的目的是比较水合氯醛-羟嗪(CH+H)和水合氯醛-咪达唑仑(CH+M)联合用于小儿MRI镇静的有效性和安全性。
在一项平行单盲随机临床试验中,60名1-7岁接受脑部MRI检查的儿童被随机分配接受最低剂量为40mg/kg的水合氯醛,并联合2mg/kg的羟嗪或0.5mg/kg的咪达唑仑。主要结局是充分镇静的有效性(Ramsay镇静评分达到5分)和MRI检查的完成情况。次要结局是临床副作用。
共研究了28名女孩(46.7%)和32名男孩(53.3%),平均年龄为2.72±1.58岁。CH+H组76.7%的患儿实现了充分镇静并完成了MRI检查。还观察到了轻度和短暂的临床副作用,如每组各有1名儿童呕吐,CH+M组有2名儿童(6.6%)出现躁动。CH+M组的不良事件更频繁。
水合氯醛-羟嗪和水合氯醛-咪达唑仑联合用于小儿MRI镇静均有效;然而,水合氯醛-羟嗪更安全。