Cost-effectiveness of Two Painkillers for Treating Pain A... | NCT00528658

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

NCT00528658

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Jun 8, 2021Actual

Enrollment

782Actual

Phase

Phase 2

Conditions

Soft Tissue Injuries

Interventions

Paracetamol
Ibuprofen
Paracetamol Placebo
Ibuprofen placebo

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Sep 11, 2007

First Submission Date that Met QC Criteria

Sep 11, 2007

First Posted Date

Sep 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2021

Last Update Posted Date

Jun 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Colin Graham, Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Name	Class
Hong Kong Academy of Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

782Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Drug: Paracetamol Drug: Ibuprofen placebo
2	Experimental	Drug: Ibuprofen Drug: Paracetamol Placebo
3	Experimental	Drug: Paracetamol Drug: Ibuprofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paracetamol	Drug	1g qid	1 3
Ibuprofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
analgesic efficacy both at rest and with movement		72 hours

Secondary Outcomes

Measure	Description	Time Frame
presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia		30 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Colin A Graham	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Shatin	NT		Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29408866	Derived	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.

ID	Term
D000082	Acetaminophen
D007052	Ibuprofen

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

ID	Type	Description	Link
HKCEM Grant 2006-07
CUHK DG 2041095