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小儿麻醉前用药中鼻内给予右美托咪定与口服咪达唑仑的比较:一项双盲随机对照试验。

A comparison of intranasal dexmedetomidine and oral midazolam for premedication in pediatric anesthesia: a double-blinded randomized controlled trial.

作者信息

Yuen Vivian M, Hui Theresa W, Irwin Michael G, Yuen Man K

机构信息

Department of Anaesthesiology, University of Hong Kong, Queen Mary Hospital, Hong Kong.

出版信息

Anesth Analg. 2008 Jun;106(6):1715-21. doi: 10.1213/ane.0b013e31816c8929.

DOI:10.1213/ane.0b013e31816c8929
PMID:18499600
Abstract

BACKGROUND

Midazolam is the most commonly used premedication in children. It has been shown to be more effective than parental presence or placebo in reducing anxiety and improving compliance at induction of anesthesia. Clonidine, an alpha(2) agonist, has been suggested as an alternative. Dexmedetomidine is a more alpha(2) selective drug with more favorable pharmacokinetic properties than clonidine. We designed this prospective, randomized, double-blind, controlled trial to evaluate whether intranasal dexmedetomidine is as effective as oral midazolam for premedication in children.

METHODS

Ninety-six children of ASA physical status I or II scheduled for elective minor surgery were randomly assigned to one of three groups. Group M received midazolam 0.5 mg/kg in acetaminophen syrup and intranasal placebo. Group D0.5 and Group D1 received intranasal dexmedetomidine 0.5 or 1 microg/kg, respectively, and acetaminophen syrup. Patients' sedation status, behavior scores, blood pressure, heart rate, and oxygen saturation were recorded by an observer until induction of anesthesia. Recovery characteristics were also recorded.

RESULTS

There were no significant differences in parental separation acceptance, behavior score at induction and wake-up behavior score. When compared with group M, patients in group D0.5 and D1 were significantly more sedated when they were separated from their parents (P < 0.001). Patients from group D1 were significantly more sedated at induction of anesthesia when compared with group M (P = 0.016).

CONCLUSIONS

Intranasal dexmedetomidine produces more sedation than oral midazolam, but with similar and acceptable cooperation.

摘要

背景

咪达唑仑是儿童最常用的术前用药。已证明在减轻焦虑和提高麻醉诱导时的依从性方面,它比家长陪伴或安慰剂更有效。可乐定,一种α2激动剂,已被建议作为替代药物。右美托咪定是一种比可乐定α2选择性更高的药物,具有更有利的药代动力学特性。我们设计了这项前瞻性、随机、双盲、对照试验,以评估鼻内给予右美托咪定在儿童术前用药中是否与口服咪达唑仑一样有效。

方法

96例计划进行择期小手术的ASA身体状况I或II级儿童被随机分配到三组中的一组。M组接受对乙酰氨基酚糖浆中的咪达唑仑0.5mg/kg和鼻内安慰剂。D0.5组和D1组分别接受鼻内右美托咪定0.5或1μg/kg以及对乙酰氨基酚糖浆。由一名观察者记录患者的镇静状态、行为评分、血压、心率和血氧饱和度,直至麻醉诱导。还记录了恢复特征。

结果

在家长分离接受度、诱导时行为评分和苏醒时行为评分方面无显著差异。与M组相比,D0.5组和D1组的患者在与父母分离时镇静程度明显更高(P<0.001)。与M组相比,D1组的患者在麻醉诱导时镇静程度明显更高(P = 0.016)。

结论

鼻内给予右美托咪定比口服咪达唑仑产生更强的镇静作用,但合作程度相似且可接受。

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