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.
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Intravenous paracetamol provides better management in postoperative pain in patients undergoing laparoscopic cholecystectomy.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA grade I/II patients, Age between 18-60 years scheduled for elective laparoscopic cholecystectomy.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Intravenous paracetamol provides better management in postoperative pain in patients undergoing laparoscopic cholecystectomy.
Time Frame: 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.
Secondary Outcomes
- Intravenous paracetamol has lesser side effects as compared to intravenous tramadol.
Investigators
Akash Maurya
Heritage Institute of Medical Sciences, Varanasi