右美托咪定用于婴儿行放射学检查补救镇静的疗效和安全性评估

Efficacy and safety of rescue sedation of intranasal dexmedetomidine versus traditional rescue techniques for radiological scans in infants less than 12 months

目的与传统镇静药物对比分析婴儿放射学检查中右美托咪定作为首剂口服水合氯醛镇静失败后补救用药的有效性和安全性。方法根据治疗意向性原则,采用前瞻性、单盲临床随机对照试验,选择于2016年1月1日—3月28日在上海交通大学医学院附属上海儿童医学中心行放射学检查且需镇静的婴儿300例,在首剂口服水合氯醛镇静失败后,分别给予5 mg/kg苯巴比妥肌内注射(苯巴比妥组,100例)、25mg/kg水合氯醛口服(水合氯醛组,100例)、1μg/kg右美托咪定滴鼻(右美托咪定组,100例)进行补救镇静。评估3组患儿补救镇静的有效性(药物起效时间、苏醒时间、总镇静时间、检查时间和镇静成功率)和安全性(血流动力学指标的变化和不良反应发生率),采用二分类Logistic回归分析镇静成功率的影响因素。结果右美托咪定组的药物起效时间显著短于水合氯醛组(P<0.01),苏醒时间、总镇静时间均显著长于苯巴比妥组和水合氯醛组(P值均<0.01);3组间检查时间的差异均无统计学意义(P值均>0.05)。苯巴比妥组镇静成功83例(83%),水合氯醛组镇静成功79例(79%),右美托咪定组镇静成功90例(90%),3组间镇静成功率的差异均无统计学意义(P值均>0.05)。3组自给药后5min至苏醒时的心率(HR)均显著慢于同组给药前基础值(P值均<0.01),自给药后10min至检查结束时的HR均显著慢于同组给药后5min(P值均<0.01),3组组内其他时间点间和组间各时间点HR的差异均无统计学意义(P值均>0.05)。3组自给药后5min至苏醒时的脉博血氧饱和度(SpO2)均显著高于同组给药前基础值(P值均<0.01),3组组内其他时间点间和组间各时间点SpO2的差异均无统计学意义(P值均>0.05)。3组间不良反应发生情况的差异均无统计学意义(P值均>0.05)。二分类Logistic回归分析未发现显著影响镇静成功率的因素(P值均>0.05)。结论 1μg/kg右美托咪定滴鼻作为婴儿传统首剂口服水合氯醛失败后补救镇静用药,起效更快,作用时间持久,且并不增加不良反应的发生,血流动力学也较稳定。

Objective To compare the efficacy and safety between intranasal dexmedetomidine and traditional sedative drugs for rescue sedation during radiological scans in infants less than 12 months. Methods Based on an intention to treat protocol, 300 infants who underwent radiological scans but were not adequately sedated after initial oral dose of 50 mg/kg chloral hydrate between.January 1st , 2016 and March 28th, 2016 were enrolled in this prospective single-blinded randomized clinical trial. They were randomly divided into three groups. Intramuscular phenobarbital 5 mg/kg, second oral chloral hydrate 25 mg/kg and intranasal dexmedetomidine 1 μg/kg were given in the three groups, respectively. The efficacy and safety of sedation were evaluated based on the onset time, wake-up time, total sedation time, scanning time, success rate of sedation, hemodynamic changes of oxygen saturation and clinical side-effects. Binary logistic regression analysis was used to evaluate influencing factors related to success rate of sedation. Results The sedation onset time in dexmedetomidine group was significantly shorter than that in chloral hydrate group （P〈0.01）. The wake-up time and the total sedation time in dexmedetomidine group were significantly longer than those in phenobarbital group and chloral hydrate group （both P〈0.01）. There were no significant differences in the scanning time between the groups （both P〉0.05）. The success rates of rescue sedation were 83%, 79% and 90% in phenobarbital group, chloral hydrate group and dexmedetomidine group, respectively （both P〉0. 05）. Heart rate （HR） from 5 min after administration to sedative recovery was significantly lower than those at baseline in the three groups （all P〈0.01 ）, and HR from 10 min after administration to the end of the scanning was also significantly lower than those at 5 min after administration in the three groups （all P〈0.01 ）. However, no significant differences were found in HR between groups or intra-group at each time point （all P 〉 0.05）. Saturation pulse oxygen （SpO2） from 5 min after administration to sedative recovery were significantly higher than those at baseline in the three groups （all P〈 0.01）. However, no significant differences were found in SpO2 between groups or intra-group at each time point （all P〉0.05）. Also, no significant differences were found in the incidence of adverse reactions among three groups （both P〉0.05）. No influencing factors were identified in the binary logistic regression models （all P〉 0.05）. Conclusion Intranasal dexmedetemidine can be used effectively and safely in infants less than 12 months during radiological scans as a rescue sedative. A dosage of dexmedetomidine 1 μg/kg will not increase the incidence of side effects and hemodynamic changes. （Shanghai Med J, 2016, 39： 729-734）