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

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ClinicalTrials.gov Identifier: NCT00528658
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : January 29, 2009
Sponsor:
Collaborator:
Hong Kong Academy of Medicine
Information provided by:
Chinese University of Hong Kong

Brief 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


Condition or disease Intervention/treatment Phase
Soft Tissue Injuries Drug: Paracetamol Drug: Ibuprofen Drug: Paracetamol Placebo Drug: Ibuprofen placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 783 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ibuprofen

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009

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

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