Trial | NCT00528658  Report issue

Title

Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries
Cost-effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-blind, Randomised Controlled Trial

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ibuprofen acetaminophen ...

  • Study Participants

    782
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 Started
Jan 31
2005
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Last Update
Jun 08
2021

Drug Paracetamol

1g qid

Drug Ibuprofen

400mg tid

Drug Paracetamol Placebo

equivalent to 1g qid

Drug Ibuprofen placebo

Equivalent to 400mg tid

1 Experimental

2 Experimental

3 Experimental

Criteria 

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
No Results Posted