A comparative study to evaluate the clinical efficacy of Intravenous Paracetamol versus Intravenous Tramadol for postoperative pain in patients undergoing Laparoscopic Cholecystectomy. A Double Blind Randomized Control Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Intravenous paracetamol provides better management in postoperative pain in patients undergoing laparoscopic cholecystectomy.
研究概览
简要总结
The study is a Double Blind Randomized Control Trial to evaluate the clinical efficacy of Intravenous Paracetamol versus Intravenous Tramadol for post-operative pain in patients undergoing Laparoscopic Cholecystectomy. in this study we will evaluate response to the drugs in term of reduction of pain at different time points i.e. before drug administration(T0), at 30th minute(T1), at 2nd hour(T2), at 4th hour(T3), at 8th hour(T4), at 16th hour(T5) and at 24th hour(T6) and will also compare the adverse effects of Intravenous Paracetamol versus Intravenous Tramadol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I/II patients, Age between 18-60 years scheduled for elective laparoscopic cholecystectomy.
排除标准
- •Patients who had history of allergy to paracetamol or tramadol, Patients with severe pain (VAS ≥ 5), Patients with signiï¬cant coronary artery disease or ischemic myocardial disease, Patients with renal disease , liver disease , chronic lung disease and haemorrhagic conditions and/or coagulopathies, Patients with history of addiction to opioids or alcohol, Patient’s refusal.
结局指标
主要结局
Intravenous paracetamol provides better management in postoperative pain in patients undergoing laparoscopic cholecystectomy.
时间窗: Pain score before drug administration (T0), 30th minute (T1), 2nd hour (T2), 4th hour (T3), 8th hour (T4), 16th hour (T5), 24th hour (T6). | Haemodynamic parameters at 0 minute, 30 minutes, 2 hr, 4 hr, 8 hr, 16 hr, 24 hr.
次要结局
- Intravenous paracetamol has lesser side effects as compared to intravenous tramadol.
研究者
Akash Maurya
Heritage Institute of Medical Sciences, Varanasi