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Completed

NCT Number: NCT00528658

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

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

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Key information

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prince of Wales Hospital

Shatin, NT, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

1g qid

Ibuprofen

Drug

400mg tid

Paracetamol Placebo

Drug

equivalent to 1g qid

Ibuprofen placebo

Drug

Equivalent to 400mg tid

Primary outcomes

  1. analgesic efficacy both at rest and with movement

    Time frame: 72 hours

Secondary outcomes

  1. presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Hong Kong Academy of Medicine

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2007
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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