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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxter Healthcare Corporation
• Collaborator: MDS Pharma Services
• Treatments: Acetaminophen; Analgesics; Pharmaceutical Solutions

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