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

August 10, 2011 updated by: Baxter Healthcare Corporation

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
        • Semmelweis Egyetem Ortopédiai Klinika
      • Békéscsaba, Hungary
        • Réthy Pál Kórház-Rendelőintézet
      • Esztergom, Hungary
        • Esztergom Város Önkormányzat Vaszary Kolos Kórháza
      • Győr, Hungary
        • Petz Aladar Megyei Oktato Korhaz
      • Kecskemet, Hungary
        • Bács-Kiskun Megyei Önkormányzat Kórháza
      • Szeged, Hungary
        • SZTE ÁOK Ortopédiai Klinika
      • Szekesfehervar, Hungary
        • Fejer Megyei Szent Gyorgy Korhaz
      • Szekszárd, Hungary
        • Tolna Megyei Önkormányzat Balassa János Kórháza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: 0.9% sodium chloride solution
Four 100 mL, 15 min IV infusions at six hour intervals
Other Names:
  • Normal saline solution
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 Names:
  • Perfalgan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 hours from first (of four) study drug doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Collaborators

MDS Pharma Services

Investigators

  • Study Director: Keyvan Tadjalli Mehr, MD, MSc, Baxter Deutschland GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

July 26, 2007

First Submitted That Met QC Criteria

July 26, 2007

First Posted (Estimate)

July 30, 2007

Study Record Updates

Last Update Posted (Estimate)

August 11, 2011

Last Update Submitted That Met QC Criteria

August 10, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-01270-A016
  • EudraCT 2006-004075-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on Paracetamol 1% solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe