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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: Paracetamol
  • IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours
• Drug: Placebo
  • IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Placebo Comparator: B

Primary Measures

• 24-hour cumulative dose of tramadol
  • Time Frame: 24 hours, defining TO as the start time of the first dose of study drug
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: 24 hours, defining TO as the start time of the first dose of study drug
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00344045

Study ID Number: CN145-010

ClinicalTrials.gov Identifier: NCT00344045

Health Authority: Spain: Spanish Agency of Medicines

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm