Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/09/2007
Date assigned
19/10/2007
Last edited
19/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Colin Graham

ORCID ID

Contact details

Trauma and Emergency Centre
Prince of Wales Hospital
Shatin
NT
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HKCEM06-07/DG2041095

Study information

Scientific title

Acronym

Study hypothesis

We hypothesise firstly that paracetamol 1 g and ibuprofen 400 mg administered orally for soft tissue injuries have equal analgesic efficacy; secondly that paracetamol has less adverse effects than ibuprofen; and that when all additional health care related costs are taken into account, that paracetamol will be the more cost-effective option.

Ethics approval

Ethics approval received from the Joint Chinese University of Hong Kong - New Territories East Cluster (CUHK-NTEC) Clinical Research Ethics Committee on the 8th October 2004 (ref: CRE-2004.266-T).

Study design

Prospective, double-blind, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Soft Tissue Injuries

Intervention

Arm 1: Paracetamol 1 g four times daily (qid) and ibuprofen placebo equivalent to 400 mg three times daily (tid)
Arm 2: Paracetamol placebo equivalent to 1 g qid and ibuprofen 400 mg tid
Arm 3: Paracetamol 1 g qid and ibuprofen 400 mg tid

Treatment will continue for three days, follow-up will continue for 30 days.

Intervention type

Drug

Phase

Not Specified

Drug names

Paracetamol, ibuprofen

Primary outcome measures

Analgesic efficacy both at rest and with movement at 72 hours.

Secondary outcome measures

1. Presence, frequency and duration of adverse effects at 30 days
2. Cost-effectiveness analysis at 30 days
3. Patient satisfaction with analgesia at 30 days

Overall trial start date

01/01/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All patients greater than 16 years presenting to the Emergency Department (ED) with isolated soft tissue injury without significant fracture between 9 am to 5 pm, Monday to Friday.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

783

Participant exclusion criteria

Patients will be excluded if there is:
1. A history of peptic ulceration or haemorrhage
2. Recent anticoagulation
3. Pregnancy
4. Adverse reaction to paracetamol or ibuprofen
5. Renal or cardiac failure
6. Hepatic problems
7. Rectal bleeding
8. Chronic Non-Steriodal Anti-Inflammatory Drug (NSAID) consumption
9. Asthma
10. Chronic obstructive pulmonary disease
11. Chronic pain syndromes
12. Prior treatment with analgesia for the same injury

Patients will also be excluded if they have a physical, visual or cognitive impairment making use of the visual analogue scale unreliable.

Recruitment start date

01/01/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Trauma and Emergency Centre
Shatin
NT
Hong Kong

Sponsor information

Organisation

Chinese University of Hong Kong (Hong Kong)

Sponsor details

Trauma and Emergency Centre
Prince of Wales Hospital
Shatin
NT
Hong Kong

Sponsor type

University/education

Website

http://www.cuhk.edu.hk

Funders

Funder type

University/education

Funder name

Chinese University of Hong Kong (Hong Kong) (Direct Grant: 2041095)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hong Kong College of Emergency Medicine (Hong Kong) (Grant: 2006-07)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes