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

Soft Tissue Injuries Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Soft Tissue Injuries
• Wounds and Injuries

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