Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain

This study has been completed.

First Received: July 26, 2007 Last Updated: August 4, 2008 History of Changes

Sponsor:	Baxter Healthcare Corporation
Collaborator:	MDS Pharma Services
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00508495

Purpose

The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).

Condition	Intervention	Phase
Pain, Postoperative	Drug: Paracetamol (acetaminophen)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Total Hip Replacement Model

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Enrollment:	148
Study Start Date:	August 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant.
Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day.

Exclusion Criteria:

Another acute or chronic painful physical condition
Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
Inability to use and understand Visual Analog Scale and Verbal Rating Score

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508495

Sponsors and Collaborators

Baxter Healthcare Corporation

MDS Pharma Services

Investigators

Study Director:

Keyvan Tadjalli-Mehr, MD

Baxter Healthcare Corporation

More Information

No publications provided

Study ID Numbers:	R-01270-A016, EudraCT 2006-004075-36
Study First Received:	July 26, 2007
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00508495 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by Baxter Healthcare Corporation:

pain, postoperative
replacement, total hip
total hip replacement
arthroplasty, replacement, hip

Additional relevant MeSH terms:

Physiological Effects of Drugs
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Acetaminophen

ClinicalTrials.gov processed this record on March 18, 2010