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临床试验/CTRI/2020/08/026971
CTRI/2020/08/026971尚未招募不适用

A randomised controlled study to compare the analgesic efficacy of Caudal Block between Bupivacaine alone and Bupivacaine with Morphine for post-operative analgesia in pediatric patients(01-05 years) undergoing lower abdominal surgeries

Government institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年8月8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
100
试验地点
1
主要终点
To compare the duration of caudal analgesia post operatively in paediatric patients aged 1-5 years undergoing lower abdominal surgery

研究概览

简要总结

Caudal injections of bupivacaine arecommonly used in children undergoing lower abdominal and urogenital surgery toprovide intraoperative analgesia. There is paucity of literature regarding useof bupivacaine with morphine in caudal analgesia for post-operative analgesia.This study has not been done earlier in our institute. Hence we plan to compareefficacy and possible side effects of bupivacaine versus mixture of bupivacaineand morphine when used in caudal analgesia for post-operative analgesia. A prospective,randomized controlled study will be conducted on patient with ASAI/II physical Status undergoing lower abdominal surgeries undergeneral anaesthesia  after obtaining approval from the hospital ethicscommittee. Prior written informed consent will be taken from parents of all thepatients in the language they understand. Total number of patients 100will be enrolled and divided into two group: GROUP –I (n = 50) will bereceiving Caudal analgesia with bupivacaine 0.25% (1 ml kg-1)GROUP-II (n = 50) will be receiving Caudal analgesia with bupivacaine 0.25% (1ml kg-1 ) and morphine 40 mcg kg-1. Pain assessment will be doneusing  FLACC score which will be recorded at 0, 4, 8, 12 and 24 hrs aftersurgery by the observer. Rescue analgesia will be givenfor FLACC score ≥ 4 in the form of Inj. Paracetamol 15 mg kg-1 intravenous. The study will be a double blind randomly allocated design. Local or systemiccomplications throughout the study will be recorded and managed accordingly. There is noconflict of interest.

研究设计

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

入排标准

年龄范围
1.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • 1.American Society of Anaesthesiology I and II physical status undergoing Lower Abdominal Surgeries.

排除标准

  • Allergic to study drugs
  • Cardiac, pulmonary,neurological and musculoskeletal diseases
  • Bleeding diathesis
  • Skin infection on back
  • Congenital anomalies of lower back
  • Patients requiring intra-operative analgesia in form of opioids
  • History of mental retardation and delayed milestones that may interfere with pain assessment.

结局指标

主要结局

To compare the duration of caudal analgesia post operatively in paediatric patients aged 1-5 years undergoing lower abdominal surgery

时间窗: 0,4,8,12,24 hours

次要结局

  • To study complications pertaining to caudal analgesia with bupivacaine and bupivacaine with morphine for post-operative analgesia in paediatric patients.(0,4,8,12,24 hours)

研究者

发起方
Government institute
申办方类型
Government medical college

研究点 (1)

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