Soft Tissue Injuries
Conditions
Keywords
Soft Tissue Injuries
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
Interventions
equivalent to 1g qid
Equivalent to 400mg tid
DRUGIbuprofen
400mg tid
DRUGParacetamol
1g qid
Sponsors
Hong Kong Academy of Medicine
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| analgesic efficacy both at rest and with movement | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia | 30 days |
Countries
Hong Kong
Outcome results
None listed