Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
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