Text Size

Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00344045
First received: June 23, 2006
Last updated: September 26, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
 Drug: Paracetamol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 24-hour cumulative dose of tramadol [ Time Frame: 24 hours, defining TO as the start time of the first dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: April 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Paracetamol
IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours
Other Name: Perfalgan
Placebo Comparator: B Drug: Placebo
IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344045

Locations
Spain
Local Institution
Alcorcon, Spain, 28922
Local Institution
Barcelona, Spain, 08024
Local Institution
Madrid, Spain, 28041
Local Institution
Madrid, Spain, 28007
Local Institution
Vizcaya, Spain, 48903
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00344045     History of Changes
Other Study ID Numbers: CN145-010
Study First Received: June 23, 2006
Last Updated: September 26, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Bristol-Myers Squibb:
Subjects with postoperative pain after Total Hip Arthroplasty

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Analgesics
Antipyretics
 Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013