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

This study has been completed.

Sponsors and Collaborators:	Baxter Healthcare Corporation 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

Drug Information available for: Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

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
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by Baxter Healthcare Corporation:

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

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pain
Acetaminophen
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009