Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries

The Chinese University of Hong Kong

Status and phase

Completed

Phase 2

Conditions

Soft Tissue Injuries

Treatments

Drug: Paracetamol

Drug: Paracetamol Placebo

Drug: Ibuprofen

Drug: Ibuprofen placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00528658

HKCEM Grant 2006-07

CUHK DG 2041095

HKCEM06-07/DG2041095

Details and patient eligibility

About

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

Enrollment

782 patients

Sex

All

Ages

16 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients >16 years presenting to the ED with isolated soft tissue injury without significant fracture
between 9am to 5pm, Monday to Friday,

Exclusion criteria

History of :
- peptic ulceration or hemorrhage
- recent anticoagulation
- pregnancy
- adverse reaction to paracetamol or ibuprofen
- renal or cardiac failure
- hepatic problems
- rectal bleeding
- chronic NSAID consumption
- asthma
- chronic obstructive pulmonary disease
- chronic pain syndromes
- prior treatment with analgesia for the same injury
- physical, visual or cognitive impairment making use of the visual analogue scale unreliable