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

Study Overview
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Brief Summary
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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

Official Title
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Cost-effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-blind, Randomised Controlled Trial

Conditions
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Soft Tissue Injuries

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Ibuprofen
* Drug: Paracetamol Placebo
* Drug: Ibuprofen placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Paracetamol<br>* 1g qid<br>Drug: Ibuprofen placebo<br>* Equivalent to 400mg tid<br>|
| Experimental: 2<br> | Drug: Ibuprofen<br>* 400mg tid<br>Drug: Paracetamol Placebo<br>* equivalent to 1g qid<br>|
| Experimental: 3<br> | Drug: Paracetamol<br>* 1g qid<br>Drug: Ibuprofen<br>* 400mg tid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic efficacy both at rest and with movement |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft Tissue Injuries