Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT00528658
Brief Summary:
Background: Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are commonly used oral analgesics in emergency departments (ED) not only in Hong Kong but throughout the world. There are no large-scale (n\>100), prospective, randomised studies comparing paracetamol with ibuprofen in the management of acute soft tissue injury.
As paracetamol is cheaper than most NSAIDs, may be as effective in the management of acute pain and possibly with fewer adverse effects, a large-scale, randomised, controlled trial is needed to answer questions of relative analgesic efficacy, safety and cost-effectiveness. Previous comparative studies on NSAIDS have been done in this unit and have suggested equivalence between two NSAIDs and paracetamol, but numbers were small and drug doses were modest.
Objective: To compare the efficacy, safety and cost between oral ibuprofen and paracetamol in pain control for acute soft tissue injuries in an ED setting
Design: Prospective, double-blind, randomised controlled trial with three arms: oral paracetamol with placebo; oral ibuprofen with placebo; paracetamol and ibuprofen in combination
Participants: 783 subjects having sustained isolated soft tissue limb injury without significant fracture presenting to the ED of Prince of Wales Hospital
Main outcome measures: Pain relief profiles of paracetamol, ibuprofen and the combination of both; adverse effect profiles of paracetamol, ibuprofen and the combination of both; overall cost effectiveness of paracetamol, ibuprofen and the combination of both from the perspective of the healthcare provider
Study:
NCT00528658
Study Brief:
Protocol Section:
NCT00528658