Analgesia in acute injury
| ISRCTN | ISRCTN21732767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21732767 |
| Secondary identifying numbers | N0013129667 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 03/08/2012
- 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
Not provided at time of registration
Contact information
Ms Penelope Shirlaw
Scientific
Scientific
Oral Medicine Department
22nd Floor, Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7188 4399 |
|---|---|
| pepe.shirlaw@gstt.sthames.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | |
| Study hypothesis | The study is designed to decide whether the COX-2 specific non-steroidal anti-inflammatory drug rofecoxib is effective in the relief of pain in patients with acute upper and lower limb injuries. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Pain, lower leg injury |
| Intervention | Patients will be randomised to receive either rofecoxib or diclofenac at the triage area. They will have regular objective and subjective pain and functional assessments and will be treated in the department (as per normal). They will receive the study drugs for a further 5 days, with ongoing assessments. |
| Intervention type | Other |
| Primary outcome measure | The main outcome measure is the change in VAS score over time after the initial dose of study medication over the next 4 hours. |
| Secondary outcome measures | Secondary outcome measures are twice daily patient's global assessments of pain and VAS score. There will be a modified SF-36 to complete on day 5. |
| Overall study start date | 19/06/2003 |
| Overall study end date | 19/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | Patients presenting to the emergency department with acute lower limb injuries. These must be less than 48 hours old and only include non-penetrating injuries with a pain score of 40 mm or more on a 100 mm Visual Analogue Scale (VAS). |
| Participant exclusion criteria | Does not match inclusion criteria |
| Recruitment start date | 19/06/2003 |
| Recruitment end date | 19/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oral Medicine Department
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Guy's and St Thomas' NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results in 'Leading Abstracts of the Third Mediterranean Emergency Medicine Congress, Nice, France; September 1-5 2005' | 01/02/2006 | No | No |
