Official Title: “Cost-Effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-Blind, Randomised Controlled Trial”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Paracetamol
  • 1g qid
• Drug: Ibuprofen
  • 400mg tid
• Drug: Paracetamol Placebo
  • equivalent to 1g qid
• Drug: Ibuprofen placebo
  • Equivalent to 400mg tid

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3

Primary Measures

• analgesic efficacy both at rest and with movement
  • Time Frame: 72 hours
    

Secondary Measures

• presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia
  • Time Frame: 30 days
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Chinese University of Hong Kong

Overall Clinical Trial Officials and Contacts

Colin A Graham Principal Investigator Chinese University of Hong Kong  

Overall Contact: Colin A Graham 85-22-632-1033 cagraham@cuhk.edu.hk

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00528658

Study ID Number: HKCEM06-07/DG2041095

ClinicalTrials.gov Identifier: NCT00528658

Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee