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

This study has been completed.

First Received on July 26, 2007. Last Updated on August 10, 2011 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) Drug: Paracetamol 1% solution Drug: 0.9% sodium chloride solution	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized 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: Hip Replacement

Drug Information available for: Chlorides Acetaminophen CT 2584 Sodium chloride

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Amount of PCA-administered morphine consumed during first six hours of study drug treatment [ Time Frame: 6 hours from first (of four) study drug doses ] [ Designated as safety issue: No ]

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)

Arms	Assigned Interventions
Experimental: Test drug	Drug: Paracetamol 1% solution Four 100 mL, 15 min IV infusions at six hour intervals
Active Comparator: Reference drug	Drug: Paracetamol (acetaminophen) Four 100 mL, 15 min IV infusions at six hour intervals Other Name: Perfalgan
Placebo Comparator: Placebo	Drug: 0.9% sodium chloride solution Four 100 mL, 15 min IV infusions at six hour intervals Other Name: Normal saline solution

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

Locations

Hungary
Semmelweis Egyetem Ortopédiai Klinika
Budapest, Hungary
Réthy Pál Kórház-Rendelőintézet
Békéscsaba, Hungary
Esztergom Város Önkormányzat Vaszary Kolos Kórháza
Esztergom, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, Hungary
Bács-Kiskun Megyei Önkormányzat Kórháza
Kecskemet, Hungary
SZTE ÁOK Ortopédiai Klinika
Szeged, Hungary
Fejér Megyei Szent György Kórház
Szekesfehervar, Hungary
Tolna Megyei Önkormányzat Balassa János Kórháza
Szekszárd, Hungary

Sponsors and Collaborators

Baxter Healthcare Corporation

MDS Pharma Services

Investigators

Study Director:

Keyvan Tadjalli Mehr, MD, MSc

Baxter Deutschland GmbH

More Information

No publications provided

Responsible Party:	Keyvan Tadjalli Mehr, MD, MSc/Medical Director, Baxter Deutschland GmbH
ClinicalTrials.gov Identifier:	NCT00508495 History of Changes
Other Study ID Numbers:	R-01270-A016, EudraCT 2006-004075-36
Study First Received:	July 26, 2007
Last Updated:	August 10, 2011
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:

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 February 09, 2012