Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries
Primary Purpose
Soft Tissue Injuries
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Paracetamol
Ibuprofen
Paracetamol Placebo
Ibuprofen placebo
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Injuries focused on measuring Soft Tissue Injuries
Eligibility Criteria
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
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
analgesic efficacy both at rest and with movement
Secondary Outcome Measures
presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia
Full Information
NCT ID
NCT00528658
First Posted
September 11, 2007
Last Updated
June 3, 2021
Sponsor
Chinese University of Hong Kong
Collaborators
Hong Kong Academy of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00528658
Brief Title
Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries
Official Title
Cost-effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-blind, Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Hong Kong Academy of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Injuries
Keywords
Soft Tissue Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
782 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
1g qid
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
400mg tid
Intervention Type
Drug
Intervention Name(s)
Paracetamol Placebo
Intervention Description
equivalent to 1g qid
Intervention Type
Drug
Intervention Name(s)
Ibuprofen placebo
Intervention Description
Equivalent to 400mg tid
Primary Outcome Measure Information:
Title
analgesic efficacy both at rest and with movement
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin A Graham
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Sha Tin
State/Province
NT
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
29408866
Citation
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.
Results Reference
derived
Learn more about this trial
Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries
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