Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Paracetamol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
The main purpose is to evaluate the analgesic efficacy of 1g of i. v. 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.
Clinical Details
Official title: A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy And Safety of IV Paracetamol Versus Placebo in Subjects With Postoperative Pain After Total Hip Arthroplasty
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 24-hour cumulative dose of tramadol
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Local Institution, Madrid 28041, Spain
Local Institution, Madrid 28007, Spain
Local Institution, Vizcaya 48903, Spain
Local Institution, Barcelona 08024, Spain
Local Institution, Alcorcon 28922, Spain
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: April 2006
Ending date: February 2008
Last updated: June 10, 2008
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