To Compare the Efficacy and Safety of Intravenous Tramadol versus Intravenous Paracetamol as Analgesics in Patients of Acute Pancreatitis: A Prospective, Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.To Determine the effectiveness of Intravenous Paracetamol and Intravenous Tramadol in treating pain.
研究概览
简要总结
patient will be randomized 1:1 and one group will receive iv paracetamol 1000 mg/100 ml, and another group will get iv tramadol 50 mg/100 ml NS and will be monitored at 24 hours, 48 hours, 72 hours, and 7 days. Radiological investigations (USG, CT, MRCP) will determine the severity of Acute Pancreatitis as per the Revised Atlanta Classification 2012 (mild, moderate to Severe, Severe). Extensive laboratory tests like CBC, LFT, ABG, Urine- analysis, lipid profile, blood glucose, GGT, serum procalcitonin, SGPT, SGOT, serum bilirubin (direct, indirect, and total), serum amylase, and serum lipase will be conducted. Pain intensity will be assessed using a Visual Analogue Scale at the baseline and at 24 hours, 48 hours, 72 hours, and 7 days if possible, with recorded changes. The comprehensive approach provides insights into the effectiveness of IV paracetamol and Tramadol in managing pain among patients with acute pancreatitis, regardless of severity. It also evaluates secondary outcomes, including duration of pain relief, impact on hospital stays, and patient satisfaction with pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of age 18 or more, with diagnosis of Acute Pancreatitis, Irrespective of severity
- •Acute pancreatitis will be diagnosed according to revised Atlanta Classification 2012, which require 2 or more of the following criteria be met for the diagnosis; (a) Abdominal pain suggestive of pancreatitis (b) Serum amylase or lipase level greater than three times the upper normal value (c) Characteristic imaging findings.
排除标准
- •Patients with severe hepatic impairment & severe renal impairment (Creatinine clearance less than 30mL/min)
- •Ongoing treatments with NSAIDs (within 24hrs)
- •History of allergy to paracetamol and/or tramadol.
结局指标
主要结局
1.To Determine the effectiveness of Intravenous Paracetamol and Intravenous Tramadol in treating pain.
时间窗: 18-24 months
2. To Compare. pain alleviation between Paracetamol and Tramadol
时间窗: 18-24 months
3. Analyzing patient-reported pain intensity outcomes
时间窗: 18-24 months
4. Potentially assessing adverse events or adverse drug reactions with Paracetamol and Tramadol
时间窗: 18-24 months
次要结局
- 1. The duration of pain alleviation provided by Tramadol & Paracetamol(2. Assessing the impact of these medications on hospital stays or re-admission rates)
研究者
DR ABHIJEET SHRIDHAR
Jawaharlal Nehru medical college and hospital Aligarh muslim University
