Comparison of postoperative analgesia between intramuscular tramadol vs intranasal tapentadol following open cholecystectomy: An open label randomized clinical triaL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
The aim of the study is to compare the efficacy of intramuscular Tramadol and intranasal Tapentadol in postoperative pain management following open cholecystectomy The primary objective is to determine and compare the degree of analgesia by intramuscular Tramadol and intranasal Tapentadol using VAS score The secondary objective is to assess and compare the adverse events of intramuscular Tramadol and intranasal Tapentadol among the study participants This is an experimental study designed as an open label parallel group randomized clinical trial The study will be conducted in the Department of Surgery and the Department of Pharmacology AGMC and GBP Hospital over a duration of six months The study population includes cholecystitis patients undergoing open cholecystectomy in the General Surgery Department AGMC and GBP Hospital Inclusion criteria include newly diagnosed cholecystitis patients aged eighteen years and above undergoing open cholecystectomy with ASA physical status class one and two Exclusion criteria include ASA class three and above age below eighteen years use of immunosuppressive drugs unwillingness to give consent pregnancy lactation and chronic kidney disease After randomization one group will receive intramuscular Tramadol one hundred milligram every eight hours for seventy two hours and the other group will receive Tapentadol nasal spray forty five milligram every eight hours for seventy two hours VAS score will be recorded two hours after each dose from the first dose on postoperative day zero up to the tenth dose on postoperative day three Rescue analgesia with injection Diclofenac sodium seventy five milligram intramuscular will be given if VAS score is five or more Time to first analgesic request after each scheduled dose will be noted for both Tramadol and Tapentadol group
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 90.00 Year(s)(—)
- 性别
- All
入选标准
- •All the newly diagnosed Cholecystitis patients undergoing Open Cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification 1 & 2 at General Surgery Department of AGMC, in the age group of 18 years and above, shall be included in the study.
排除标准
- •Patients with ASA class 3 or above status.
- •Patients below 18 years of age.
- •Patients on immunosuppressive drugs.
- •Patients unwilling for giving consent.
- •Pregnant and lactating women.
- •Subjects with Chronic Kidney Disease.
研究者
PRAJNAPARMITA SAHA
AGARTALA GOVERNMENT MEDICAL COLLAGE
