A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain

Postoperative Pain Clinical Trial

Official title: A Multicenter, Randomized, Double-blind, and Parallel Groups, Placebo-controlled Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain.

Status Terminated

Clinical Trial Summary

The purpose of this study is to study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain and evaluate its tolerability and safety profile.

Clinical Trial Description

This is a phase III, national, multicenter, randomized, double-blind, parallel groups, and placebo-controlled.

Patients will be randomized to receive either ibuprofen or placebo. Stratified randomization will be used to assign eligible patients to a stratum according to type of surgery and centre. Randomization sequence will be generated in the coordinating centre.

Blinding of the patient and study personnel evaluating response will be warranted by adequate drug labelling.

All patients will receive morphine administered by patient controlled analgesia (PCA) following a similar schedule in all centres: 1 mg bolus dose with a close time of 5 min and a maximum of 10 mg in an hour and a maximum of 30 mg in 4 hours. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

• NCT number: NCT02254525
• Study type: Interventional
• Source: Biomendi S.A.U.
• Status: Terminated
• Phase: Phase 3
• Start date: May 2012
• Completion date: July 2014