跳至主要内容
临床试验/CTRI/2025/03/081696
CTRI/2025/03/081696尚未招募不适用

Comparison between effectiveness of Dexmedetomidine and Dexmedetomidine-ketamine combination as an intranasal premedication in paediatric infraumbilical surgeries

Dr Fehima Haris1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2025年1月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
144
试验地点
1
主要终点
To compare the effectiveness of intranasal dexmedetomidine versus intranasal dexmedetomidine-ketamine combination as a premedication in terms of mask acceptance score in paediatric patients undergoing general anaesthesia for infraumbilical surgeries

研究概览

简要总结

This is a comparative observation study comparing effectiveness of intranasal dexmedetomidine 3mcg/kg with intranasal dexmedetomidine(2mcg/kg)-ketamine(2mg/kg) combination as a premedication in paediatric infraumbilical surgeries . While there has been much research on the individual effectiveness of dexmedetomidine and ketamine as paediatric premedication,  there has been limited evidence on their combined efficacy . Our primary objective is to compare effectiveness of intranasal dexmedetomidine versus dexmedetomidine-ketamine combination as a premedication in terms of mask acceptance score in paediatric patients undergoing general anaesthesia for infraumbilical surgeries.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

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

入选标准

  • Paediatric patients of age 1-6 years of either sex undergoing elective infraumbilical surgeries of ASA physical status I or II.

排除标准

  • Known allergy to study drugs Cardiac arrhythmia or congenital heart disease Raised intracranial tension Children with mental retardation Intranasal mass or nasal bleeding.

结局指标

主要结局

To compare the effectiveness of intranasal dexmedetomidine versus intranasal dexmedetomidine-ketamine combination as a premedication in terms of mask acceptance score in paediatric patients undergoing general anaesthesia for infraumbilical surgeries

时间窗: Mask acceptance score will be assessed at the time of induction that is 30 minutes after giving premedication

次要结局

  • To assess level of sedation using Ramsay sedation score(To determine Child-parent separation score)

研究者

发起方
Dr Fehima Haris
申办方类型
Other [Principal investigator]

研究点 (1)

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