跳至主要内容
临床试验/CTRI/2017/03/008245
CTRI/2017/03/008245招募中不适用

Comparison of caudal Dexmedetomidine versus Morphine as an adjunct to Bupivacaine in children undergoing lower abdominal surgeries

Armed forces Medical College Pune1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年4月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
To compare the post operative analgesia produced by Dexmeditomidine and Morphine when used as additive to bupivacaine (using FLACC pain scale with 0-10 score range)

研究概览

简要总结

Caudal epidural blocks are the most commonly used technique providing intra and postoperative analgesia in pediatric lower abdominal surgeries. Caudal  anlgesia proved to be simple and effective technique.Inspite of using long acting local anaesthetics, the main disadvantage of caudal analgesia remains the relatively short duration of action.The practice of adding adjunct analgesic drugs to local anesthetics for caudal block is common.  Clinically, the addition of both morphine and dexmedetomidine prolongs the duration of caudal analgesia. Aim of the study is to compare the analgesic effects of  Dexmedetomidine and morphine  as  adjuncts  to Bupivacaine in caudal block.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Investigator Blinded

入排标准

年龄范围
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I and II
  • Pediatric patients between 2-10 yeras undergoing lower abdominal surgeries
  • Written informed parental consent
  • Elective surgery.

排除标准

  • Known allergy to study drugs
  • History of developmental delay or mental retardation
  • Patients with coagulopathies
  • Signs of infection at the site of caudal block
  • Skeletal deformities in the caudal region
  • Patient or parental refusal
  • Neurological disorder or deficit.

结局指标

主要结局

To compare the post operative analgesia produced by Dexmeditomidine and Morphine when used as additive to bupivacaine (using FLACC pain scale with 0-10 score range)

时间窗: In post anesthesia care unit and every 2 Hourly

次要结局

  • To compare the post operative sedation when Dexmedetomidine and Morphine used as adjuncts to Bupivacaine in caudal block(using modified Ramsay Sedation Scale)(In Post Anaesthesia Care Unit and every 4 hrly)

研究者

发起方
Armed forces Medical College Pune
申办方类型
Government medical college

研究点 (1)

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