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

Baxter Healthcare Corporation8 sites in 1 country148 target enrollmentAugust 2007

ConditionsPain, Postoperative

InterventionsParacetamol 1% solution Paracetamol (acetaminophen)0.9% sodium chloride solution

DrugsParacetamol (acetaminophen)Paracetamol 1% solution 0.9% sodium chloride solution

Overview

Phase: Phase 3
Intervention: Paracetamol 1% solution
Conditions: Pain, Postoperative
Sponsor: Baxter Healthcare Corporation
Enrollment: 148
Locations: 8
Primary Endpoint: Amount of PCA-administered morphine consumed during first six hours of study drug treatment
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

March 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baxter Healthcare Corporation

Eligibility 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