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
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