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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

782 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analgesic Effect of Paracetamol, Paracetamol + Codeine, Ibuprofen and Their Combination

NCT00921700

Pain, Postoperative

COMPLETED PHASE4

Analgesic Effect of Ibuprofen, Paracetamol (Acetaminophen), and Paracetamol (Acetaminophen) Plus Codeine on Acute Pain

NCT00699114

Surgery

COMPLETED PHASE4

Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

NCT03224403

Post-operative Dental Pain

COMPLETED PHASE3

Ibuprofen Plus Acetaminophen for Enhanced Pain Reduction

NCT04630834

Pain, Acute

UNKNOWN PHASE4

An Effectiveness and Safety Study Comparing Acetaminophen (3900 mg/Day) to Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.

NCT00240838

Pain

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Soft Tissue Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

1g qid

Ibuprofen placebo

Intervention Type DRUG

Equivalent to 400mg tid

2

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

400mg tid

Paracetamol Placebo

Intervention Type DRUG

equivalent to 1g qid

3

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

1g qid

Ibuprofen

Intervention Type DRUG

400mg tid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paracetamol

1g qid

Intervention Type DRUG

Ibuprofen

400mg tid

Intervention Type DRUG

Paracetamol Placebo

equivalent to 1g qid

Intervention Type DRUG

Ibuprofen placebo

Equivalent to 400mg tid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No