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临床试验/CTRI/2025/01/079431
CTRI/2025/01/079431尚未招募不适用

A prospective randomised study to compare intravenous paracetamol as preemptive vs preventive analgesic on postoperative pain in open elective below umbilical surgeries under general anaesthesia in paediatric patients

Jawaharlal nehru medical collage AMU1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月5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
50
试验地点
1
主要终点
Time to first rescue paracetamol after extubation

研究概览

简要总结

Background:

Managing postoperative pain in children is challenging due to their limited ability to express pain and the risks of traditional analgesics like opioids and NSAIDs. Intravenous paracetamol is a safer alternative with proven efficacy. Pre-emptive analgesia (administering analgesics before surgical trauma) may reduce pain and analgesic needs compared to preventive analgesia (after surgery).

Purpose:

The trial compares the effectiveness of intravenous paracetamol given pre-emptively versus preventively on postoperative pain in pediatric patients undergoing elective open below-umbilical surgeries under general anesthesia.

Objectives:

• Primary: Time to first rescue paracetamol dose.

• Secondary: Total analgesic consumption, pain scores, side effects, and parental satisfaction within 24 hours post-surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • weight more than 10kgs open abdominal surgeries operation time less than 120 minutes ASA 1 and ASA2.

排除标准

  • Refusal of patients attendant/guardian 2) psychiatric illness.
  • H/O allergy /hypersensitivity to paracetamol, NSAIDS 4) Haemodynamically unstable patients.
  • Hepatic and renal dysfunctions 6) Use of anticoagulants.

结局指标

主要结局

Time to first rescue paracetamol after extubation

时间窗: 1 hr, 24 hr

次要结局

  • 1. Total paracetamol consumption in 24hours post surgery(mg)(2. Total number of patients requiring rescue paracetamol)

研究者

发起方
Jawaharlal nehru medical collage AMU
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mushahid Raza Khan

Jawaharlal nehru Medical College,Aliagrh Muslim University

研究点 (1)

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