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

NCT00528658 | Completed Phase 2

• 3 other identifiers: HKCEM06-07/DG2041095HKCEM Grant 2006-07CUHK DG 2041095
• Study Type: interventional
• Target: 782
• Locations: 1 country
• Sites: 1

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

Conditions

Soft Tissue Injuries

Keywords

Soft Tissue Injuries

Outcome Measures

Primary Outcomes (1)

• analgesic efficacy both at rest and with movement

  72 hours

Secondary Outcomes (1)

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

  30 days

Study Arms (3)

1

EXPERIMENTAL

Drug: Paracetamol; Drug: Ibuprofen placebo

2

EXPERIMENTAL

Drug: Ibuprofen; Drug: Paracetamol Placebo

3

EXPERIMENTAL

Drug: Paracetamol; Drug: Ibuprofen

Interventions

Paracetamol DRUG

1g qid

1; 3

Ibuprofen DRUG

400mg tid

2; 3

Paracetamol Placebo DRUG

equivalent to 1g qid

2

Ibuprofen placebo DRUG

Equivalent to 400mg tid

1

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients \>16 years presenting to the ED with isolated soft tissue injury without significant fracture
• between 9am to 5pm, Monday to Friday,

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hong Kong Academy of Medicine: collaborator

Study Sites (1)

Prince of Wales Hospital

Shatin, NT, Hong Kong

Location

Related Publications (1)

• Hung KKC, Graham CA, Lo RSL, Leung YK, Leung LY, Man SY, Woo WK, Cattermole GN, Rainer TH. Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial. PLoS One. 2018 Feb 6;13(2):e0192043. doi: 10.1371/journal.pone.0192043. eCollection 2018.

  PMID: 29408866 DERIVED

MeSH Terms

Conditions

Soft Tissue Injuries

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Colin A Graham

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: January 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

HK (1)