Cost-effectiveness analysis of oral paracetamol and ibuprofen for treating pain after soft tissue limb injuries: double-blind, randomised controlled trial
| ISRCTN | ISRCTN94738550 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94738550 |
| ClinicalTrials.gov (NCT) | NCT00528658 |
| Protocol serial number | HKCEM06-07/DG2041095 |
| Sponsor | Chinese University of Hong Kong (Hong Kong) |
| Funders | Chinese University of Hong Kong (Hong Kong) (Direct Grant: 2041095), Hong Kong College of Emergency Medicine (Hong Kong) (Grant: 2006-07) |
- Submission date
- 06/09/2007
- Registration date
- 19/10/2007
- Last edited
- 15/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Colin Graham
Scientific
Scientific
Trauma and Emergency Centre
Prince of Wales Hospital
Shatin
NT
Hong Kong
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, double-blind, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Cost-effectiveness analysis of oral paracetamol and ibuprofen for treating pain after soft tissue limb injuries: double-blind, randomised controlled trial |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Paracetamol, ibuprofen |
| Primary outcome measure(s) |
Analgesic efficacy both at rest and with movement at 72 hours. |
| Key secondary outcome measure(s) |
1. Presence, frequency and duration of adverse effects at 30 days |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 783 |
| Total final enrolment | 782 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Trauma and Emergency Centre
Shatin
NT
Hong Kong
NT
Hong Kong
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/02/2018 | 15/07/2021 | Yes | No |
Editorial Notes
15/07/2021: ClinicalTrials.gov number, total final enrolment and publication reference added.
