Analgesia in acute injury

ISRCTN	ISRCTN21732767
DOI	https://doi.org/10.1186/ISRCTN21732767
Protocol serial number	N0013129667
Sponsor	Department of Health
Funder	Guy's and St Thomas' NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Penelope Shirlaw
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
Email	pepe.shirlaw@gstt.sthames.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	The main outcome measure is the change in VAS score over time after the initial dose of study medication over the next 4 hours.
Key secondary outcome measure(s)	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.
Completion date	19/12/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key 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).
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	19/06/2003
Date of final enrolment	19/12/2003

Oral Medicine Department

London
SE1 9RT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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