Cost-Effectiveness of Two Painkillers for Treating Pain After Limb Injuries: Randomised Controlled Trial - Full Text View

Sponsors and Collaborators:	Chinese University of Hong Kong Hong Kong Academy of Medicine
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00528658

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 II

Drug Information available for: Ibuprofen Dexibuprofen Acetaminophen

U.S. FDA Resources

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

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
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental	Drug: Paracetamol 1g qid Drug: Ibuprofen placebo Equivalent to 400mg tid
2: Experimental	Drug: Ibuprofen 400mg tid Drug: Paracetamol Placebo equivalent to 1g qid
3: Experimental	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

Contacts

Contact: Colin A Graham

85-22-632-1033

cagraham@cuhk.edu.hk

Locations

Hong Kong, NT
Prince of Wales Hospital	Recruiting
Sha Tin, NT, Hong Kong
Principal Investigator: Colin A Graham

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

Study ID Numbers:	HKCEM06-07/DG2041095, HKCEM Grant 2006-07, CUHK DG 2041095
Study First Received:	September 11, 2007
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00528658
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:

Soft Tissue Injuries

Study placed in the following topic categories:

Ibuprofen
Soft Tissue Injuries
Wounds and Injuries

Disorders of Environmental Origin
Pain
Acetaminophen

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009