Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty
- Registration Number
- NCT00344045
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of the opioid tramadol in the treatment of postoperative pain following total hip arthroplasty.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
Inclusion Criteria
- Spinal anesth
- BMI 10-35
- No pain conditions/concom med may alter pain quantif.
Exclusion Criteria
- Other add. surgery
- Liver/Renal function altered
- coagulation alterations
- Respir / Cardiac insufficiency
- Agents affecting microsomal syst
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Placebo - A Paracetamol -
- Primary Outcome Measures
Name Time Method 24-hour cumulative dose of tramadol 24 hours, defining TO as the start time of the first dose of study drug
- Secondary Outcome Measures
Name Time Method Sum of tramadol and Boluses number, Time from study drug start to tramadol start, total opioid use, Pain intensity scores/diff. from baseline, Global efficacy evaluation, Number of AE, Sedation level, Nausea/Vomiting, Antiemetic needs. 24 hours, defining TO as the start time of the first dose of study drug
Trial Locations
- Locations (1)
Local Institution
🇪🇸Vizcaya, Spain