水合氯醛口服复合右美托咪定滴鼻用于小儿核磁共振检查镇静的疗效及安全性评估

The evaluation of the efficacy and safety of sedation of oral chloral hydrate combination with intranasal dexmedetomidine for magnetic resonance imaging in pediatric patients

目的分析水合氯醛口服复合不同剂量右美托咪定滴鼻用于小儿核磁共振成像（magnetic resonance image，MRI）检查镇静的有效性及安全性。方法前瞻性、完全随机、单盲、队列研究。我院2014年9月1日～11月31日行MRI检查的患儿247例，50mg／kg水合氯醛口服分别复合2．0（A组）、1．5（B组）、1．0ug／kg（C组）右美托咪定滴鼻用于小儿MRI镇静检查的成功率及副作用。比较起效时间、苏醒时间及总镇静时间，分层分析年龄及发育状况对镇静成功率的影响。结果MRI检查总体镇静成功率为89．1％。C组苏醒时间及总镇静时间分别为（52±27）min和（87±27）min，其与A组、B组比较明显缩短（P〈0．05）。3组镇静成功率分别为91．5％、91．7％和84％，副作用发生率分别为6．1％、8．3％和4．9％，差异均无统计学意义（P〉0．05）。年龄及发育状况不影响镇静成功率。结论水合氯醛复合右美托咪定可有效、安全地用于小儿MRI检查的镇静。50mg／kg水合氯醛口服复合1．0ug／kg右美托咪定滴鼻可满足日常MRI检查的镇静需求。

Objective To evaluate the efficacy and safety of sedation of oral chloral hydrate combination with intranasal dexmedetomidine for magnetic resonance image （MRI） in pediatric patients. Methods In a prospective single-blinded randomized clinical trial, a total 247 children for MRI were randomly assigned to oral chloral hydrate of 50 mg/kg combination with different intranasal dexmedetomidine doses of 2.0 （group A）, 1.5 ug/kg （group B） and 1.0 ug/kg （group C）, respectively. The efficacy and safety of sedative regimens were evaluated based on the sedation onset time, wake-up time, total sedation time and clinical sideeffects. A stratified analysis was used to explore the effects of age and developmental status on the success rate of sedation in pediatric patients. Results The total success rate of sedation for MRI was 89.1%. The wake-up time was（52＋27） min and the total sedation time was（ 87±27 ） min in group C, which were shorter significantly compared with group A and group B （P〈0.05）. However, The success rate of sedation among three groups was 91.5%, 91.7% and 84% and the incidence of side-effects was 6.1%, 8.3% and 4.9% separately with no significantly differences （P〉0.05）. Age and developmental status were not independent factors of the success rate of sedation. Conclusions Oral chloral hydrate combined with intranasal dexmedetomidine could be used effectively and safely for pediatric sedation in MRI. A dosage of intranasal dexmedetomidine 1 ug/kg with oral chloral hydrate 50 mg/kg was appropriate for routine sedation of MRI scan in pediatric patients.