comparing the efficacy and safety of rectal diclofenac versus intramuscular tramadol for postoperative pain management in adult patients undergoing fistula in ano surgery in a tertiary care centre : A randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Postoperative pain management is a critical factor in recovery following anorectal surgeries such as fistula in ano. While tramadol is a commonly used central analgesic in India, it often fails to target local inflammatory pain and is associated with significant side effects like nausea and vomiting. This prospective, randomized controlled trial was conducted at a tertiary care centre in Chennai to compare the efficacy of 100 mg rectal diclofenac suppositories against 50 mg intramuscular tramadol. The study enrolled 60 adult patients (ASA I–II) who were randomized into two equal groups of 30. Both groups received standardized background analgesia with intravenous paracetamol. Pain intensity was measured using the visual analog scale (VAS) at 1, 6, 12, and 24 hours postoperatively. The results demonstrated that the diclofenac group had significantly lower pain scores at 6 and 12 hours compared to the tramadol group. Furthermore, the incidence of nausea was significantly lower in the diclofenac group (6.7 percent) compared to the tramadol group (33.3 percent). The study concludes that rectal diclofenac provides superior intermediate-phase analgesia and better tolerability, making it an effective opioid-sparing option for fistula surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Age- 18–70 years Sex-Both males and females ASA status- ASA Physical Status I–II Procedure- Elective perineal surgery for fistula-in-ano Consent Willingness to participate and provide written informed consent Evaluation- Completed preoperative clinical, laboratory, and anesthetic assessment.
排除标准
- •Known allergy or hypersensitivity to diclofenac, NSAIDs, or tramadol History of bronchial asthma Bleeding disorders or abnormal coagulation profile Hepatic or renal dysfunction Pregnancy or lactation Concomitant use of medications interacting with diclofenac (e.g., anticoagulants, nephrotoxic agents).
研究者
Dr Abhishek Reji
SRM Medical College Hospital and Research Centre
