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

This study has been completed.
Sponsor:
Collaborator:
Hong Kong Academy of Medicine
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00528658
First received: September 11, 2007
Last updated: January 28, 2009
Last verified: January 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Soft Tissue Injuries
 Drug: Paracetamol
Drug: Ibuprofen
Drug: Paracetamol Placebo
Drug: Ibuprofen placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cost-Effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-Blind, Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • analgesic efficacy both at rest and with movement [ Time Frame: 72 hours ]

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

Estimated Enrollment: 783
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Paracetamol
1g qid
Drug: Ibuprofen placebo
Equivalent to 400mg tid
Experimental: 2 Drug: Ibuprofen
400mg tid
Drug: Paracetamol Placebo
equivalent to 1g qid
Experimental: 3 Drug: Paracetamol
1g qid
Drug: Ibuprofen
400mg tid

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528658

Locations
Hong Kong
Prince of Wales Hospital
Sha Tin, NT, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Hong Kong Academy of Medicine
Investigators
Principal Investigator: Colin A Graham Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Colin A Graham, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00528658     History of Changes
Other Study ID Numbers: HKCEM06-07/DG2041095, HKCEM Grant 2006-07, CUHK DG 2041095
Study First Received: September 11, 2007
Last Updated: January 28, 2009
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Soft Tissue Injuries

Additional relevant MeSH terms:
Soft Tissue Injuries
Wounds and Injuries
Acetaminophen
Ibuprofen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013