跳至主要内容
临床试验/CTRI/2021/03/032151
CTRI/2021/03/032151已完成不适用

A Comparative study of dexmedetomidine versus dexamethasone as an adjuvant to 0.2% levobupivacaine in caudal block for post operative analgesia in paediatric patients undergoing infraumbilical surgeries

Jawaharlal Nehru medical college ajmer1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年3月20日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Primary outcome of study will be assesment of Duration of analgesia (from the time of caudal injection to the time at which FLACC pain Pain score 4 or more)

研究概览

简要总结

The aim of study will be  to compare the efficacy and safety of addition of dexmedetomidine versus dexamethasone to caudal 0.2% levobupivacaine on postoperative analgesia in paediatric patients undergoing infraumbilical surgeries

Primary objective  will be to assess duration of analgesia (from the time of caudal block to the time at which FLACC Pain score 4 or more)

Secondary objective will be to assess

1.postoperative sedation

  1. Hemodynamic changes

3.Total number of doses of rescue analgesia in 24 hours

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 8.00 Year(s)(—)
性别
All

入选标准

  • 1.patients between the age group of 1year and 8year of both sexes undergoing various infraumbilical surgeries
  • Patients belonging to ASA 1 and 2 grades 3.parental consent.

排除标准

  • 1.patients with known allergy to the study drugs
  • Suspected coagulopathy
  • Infection at site of caudal block 4.History of developmental delay and neurological diseases
  • Skeletal deformities in the caudal region 6.parental refusal.

结局指标

主要结局

Primary outcome of study will be assesment of Duration of analgesia (from the time of caudal injection to the time at which FLACC pain Pain score 4 or more)

时间窗: Duration of study will be around 1year

次要结局

  • Secondary outcome of study will be assesment of 1.postoperative sedation(2. Hemodynamic changes)

研究者

申办方类型
Government medical college

研究点 (1)

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