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临床试验/CTRI/2024/05/066958
CTRI/2024/05/066958已完成3 期

A comparison of preemptive paracetamol, paracetamol-diclofenac and paracetamol-ketorolac combination on post operative pain after elective abdominal surgery under general anesthesia

GAJRA RAJA MEDICAL COLLEGE GWALIOR1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2024年5月17日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
99
试验地点
1
主要终点
vas score less than 4 in pcm plus ketorolac group

研究概览

简要总结

A Prospective Randomized Control Study Comparing Preemptive Paracetamol, Paracetamol-Diclofenac, and Paracetamol-Ketorolac for Postoperative Pain After Elective Abdominal Surgery Under General Anaesthesia”

This prospective randomized double-blind controlled study was conducted at the Department of Anaesthesiology, G.R. Medical College & J.A. Group of Hospitals, Gwalior, between April 2023 and March 2025. A total of 99 adult patients of ASA physical status I and II, aged between 20 and 60 years, scheduled for elective abdominal surgeries under general anaesthesia, were enrolled after obtaining informed consent. The patients were randomly allocated into three groups of 33 each. Group P received 1 g intravenous (IV) paracetamol alone, Group PD received 1 g IV paracetamol combined with 75 mg IV diclofenac, and Group PK received 1 g IV paracetamol combined with 30 mg IV ketorolac. All drugs were administered just before surgical incision.

The primary objective of the study was to compare the time to first rescue analgesia among the three groups. Secondary objectives include observation of any adverse drug effects and others like evaluation of postoperative pain using the Visual Analogue Scale (VAS), monitoring of hemodynamic parameters. Standardized general anaesthesia protocols were followed for all patients, and postoperative analgesia was assessed using the VAS at multiple intervals over 24 hours. Rescue analgesia was provided with 100 mg IV tramadol whenever VAS exceeded 4.

The results demonstrated that the group receiving the paracetamol-ketorolac combination (Group PK) experienced significantly prolonged pain-free periods, with delayed requirement for rescue analgesia compared to the other two groups. This group also recorded consistently lower VAS scores during the initial postoperative hours, suggesting superior analgesic efficacy.

The paracetamol-diclofenac group (Group PD) showed intermediate effectiveness, offering better pain relief than paracetamol alone but less than the ketorolac combination. Group P, which received only paracetamol, had the earliest onset of postoperative pain and required earlier rescue analgesia.

Hemodynamic parameters, including heart rate, blood pressure, and oxygen saturation, remained comparable across all groups throughout the observation period, indicating no significant cardiovascular disturbances with any of the analgesic regimens. Adverse effects such as nausea, vomiting, sedation, and shivering were mild and occurred with similar frequency in all groups, with no major complications reported.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA PHYSICAL GRADE 1 AND 2 WEIGHT 40-90KG.

排除标准

  • Refusal of patient ASA grade 3 and 4 Uncooperative patients obesity steroid therapy Pregnancy other comorbidities.

结局指标

主要结局

vas score less than 4 in pcm plus ketorolac group

时间窗: 24 hour

次要结局

  • pcm plus ketrolac have less side effect than pcm plus diclofenac(within 24 hour)

研究者

发起方
GAJRA RAJA MEDICAL COLLEGE GWALIOR
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

NEHA PARMAR

DEPARTMENT OF ANAESTHESIOLOGY

研究点 (1)

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