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临床试验/CTRI/2018/04/013062
CTRI/2018/04/013062已完成4 期

Comparison between oral dexmedetomidine and oral midazolam as premedicant in children undergoing herniotomy

Government Medical College Kozhikode1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年3月28日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Level of sedation, parental separation anxiety, IV acceptability

研究概览

简要总结

Background and Aims: Midazolam has been the most popular premedicant in children despite its side effects. Dexmedetomidine with its favourable clinical profile is a suitable alternative, but with limited research. The aim of this study was to compare the effectiveness of dexmedetomidine and midazolam as oral premedicants in children

Materials and methods: 80 children of ASA PS I scheduled for elective herniotomy were included in this prospective randomized observational study. Patients were randomly assigned to receive either dexmedetomidine 4microgram/ kg or midazolam 0.5mg/kg orally 40min prior to induction. Preoperative sedation, response to parental separation and venepuncture, emergence agitation, recovery nurse satisfaction and side effects were compared between the two groups. quantitative data were compared using the unpaired Student"s t- test and categorical variables with Chi-square test

Results: Pre-operative sedation, response to parental separation and venepuncture were similar among the two groups. The dexmedetomidine grouo had a significantly lower incidence and severity of emergence agitation. Recovery nurse satisfaction was also higher in the dexmedetomidine group. However, incidence of bradycardia and hypotension was more.

Conclusion: Premedication with oral dexmedetomidine is as effective as oral midazolam and produces lesser emergence agitation, though side effects like hypotension and bradycardia may occur

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
1.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Belonging to the American Society of Anesthesiologist physical status Ι Posted for elective herniotomy under general anesthesia.

排除标准

  • Patients with a known allergy to the study drugs Mental retardation Neurobehavioral problems.

结局指标

主要结局

Level of sedation, parental separation anxiety, IV acceptability

时间窗: Before induction of anaesthesia

次要结局

  • Nurse satisfaction, emergence delirium(After surgery)

研究者

申办方类型
Government medical college

研究点 (1)

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