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

Baxter

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Paracetamol 1% solution; Drug: 0.9% sodium chloride solution; Drug: Paracetamol (acetaminophen)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00508495

R-01270-A016

EudraCT 2006-004075-36

Details and patient eligibility

About

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).

Enrollment: 148 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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148 participants in 3 patient groups, including a placebo group

Test drug

Experimental group

Treatment:

Drug: Paracetamol 1% solution

Reference drug

Active Comparator group

Treatment:

Drug: Paracetamol (acetaminophen)

Placebo

Placebo Comparator group

Treatment:

Drug: 0.9% sodium chloride solution