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右美托咪定用于小婴儿行放射学检查补救镇静的疗效及安全性评估
The evaluation of the efficacy and safety of rescue sedation of intranasal dexmedetomidine vs traditional rescue techniques for radiological scans in infants less than 12 months

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DOI:
作者:
卞勇
Bian Yong
作者单位:
上海儿童医学中心麻醉科
Department of Anesthesiology, Shanghai Children’s Medical Center, Shanghai Jiao Tong University School of Medicine
关键词:
放射学检查；补救镇静；右美托咪定；婴儿
Radiological scans；Rescue sedation；Dexmedetomidine；Infants
摘要:
目的 与传统镇静药物对比分析小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及安全性。方法 根据治疗意向性原则，前瞻性、随机、单盲临床随机对照试验分析我院2016年1月1日-3月28日与我院行放射学检查且需镇静的小婴儿300例，比较首剂口服水合氯醛失败后5mg/kg肌肉注射苯巴比妥（A组）、25mg/kg口服水合氯醛（B组）、1g/kg右美托咪定滴鼻补救镇静的成功率及不良反应；比较起效时间、苏醒时间及总镇静时间；评估血流动力学参数，包括血氧饱和度及心率的变化。结果 A组、B组及C组放射学检查补救镇痛成功率为分别为83%、79%、90%。不良反应率分别为7%、12%、8%，无显著性差异。C组起效时间、苏醒时间及总镇静时间分别为8（7）、67.5（40）、115（40），与A组与B组比较有显著性差异。三组血流动力学参数比较，包括心率及血氧饱和度变化无显著性差异。三组心率随时间变化都有下降趋势。而血氧饱和度则都有上升趋势。结论 右美托咪定滴鼻可以有效的作为小婴儿放射学检查的补救镇静药物。1g/kg右美托咪定滴鼻并不增加不良反应及血流动力学变化。
Objective The purpose of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine compared with traditional rescue techniques for rescue sedation during radiological scans in infants less than 12 months Methods On an intention to treat protocol, of this prospective single-blinded randomized clinical trial, a total 300 children who were not adequately sedated after initial oral dose of 50 mg/kg chloral hydrate were randomly divided into three groups. Group A received intramuscular Phenobarbital of 5mg/kg. Group B received second oral dose chloral hydrate 25 mg/kg. Group C received intranasal dexmedetomidine 1g/kg. The efficacy and safety of sedative regimens were evaluated based on the sedation onset time, wake-up time, total sedation time and clinical side-effects. The hemodynamic changes of oxygen saturation and heart rate were recorded. Results The success rate of rescue sedation among three groups was 83%, 79% and 90% and the incidence of side-effects were 7%, 12% and 8% separately with no significantly differences (P ≥ 0.05). The sedation induced time, wake-up time and the total sedation time in group C were 8(7)min, 67.5(40)min, 115(40)min respectively which had statistically differences with group A and group B. There were no significant differences in hemodynamic changes among three groups. HR decreased significantly with time among groups. And oxygen saturation of three groups was improved. Conclusions Intranasal dexmedetomidine could be used effectively and safely in infants less than 12 months during radiological scans as a rescue sedative. A dosage of intranasal dexmedetomidine 1g/kg did not increase the incidence of side effects and hemodynamic changes.

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