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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00528658
Other study ID # HKCEM06-07/DG2041095
Secondary ID HKCEM Grant 2006
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2005
Est. completion date December 2008

Study information

Verified date June 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 782
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 16 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Hong Kong Prince of Wales Hospital Sha Tin NT

Sponsors (2)

Lead Sponsor Collaborator
Chinese University of Hong Kong Hong Kong Academy of Medicine

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary analgesic efficacy both at rest and with movement 72 hours
Secondary presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia 30 days
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