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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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26 July 2021 |
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Main ID: |
ISRCTN94738550 |
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Date of registration:
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19/10/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cost-effectiveness analysis of oral paracetamol and ibuprofen for treating pain after soft tissue limb injuries: double-blind, randomised controlled trial
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Scientific title:
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Cost-effectiveness analysis of oral paracetamol and ibuprofen for treating pain after soft tissue limb injuries: double-blind, randomised controlled trial |
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Date of first enrolment:
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01/01/2005 |
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Target sample size:
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783 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN94738550 |
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Study type:
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Interventional |
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Study design:
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Prospective, double-blind, randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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Hong Kong
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Colin
Graham |
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Address:
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Trauma and Emergency Centre
Prince of Wales Hospital
NT
Shatin
Hong Kong |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Soft Tissue Injuries
Injury, Occupational Diseases, Poisoning
Soft Tissue Injuries
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Intervention(s)
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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.
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Primary Outcome(s)
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Analgesic efficacy both at rest and with movement at 72 hours.
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Secondary Outcome(s)
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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
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Secondary ID(s)
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NCT00528658
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HKCEM06-07/DG2041095
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Source(s) of Monetary Support
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Chinese University of Hong Kong (Hong Kong) (Direct Grant: 2041095), Hong Kong College of Emergency Medicine (Hong Kong) (Grant: 2006-07)
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Ethics review
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Status:
Approval date:
Contact:
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).
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2007 |
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URL:
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