Randomised controlled prospective clinical trial to evaluate the effectiveness of Ametop cream as an adjunctive analgesic agent in extracorporeal shock wave lithotripsy

ISRCTN	ISRCTN56273457
DOI	https://doi.org/10.1186/ISRCTN56273457
Protocol serial number	N0263152091
Sponsor	Department of Health
Funders	UCL Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr S Choong
Scientific

Department of Urology and Nephrology
Bland Sutton Building
48 Riding House Street
London
W1P 7PN
United Kingdom

Phone	+44

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Can cream be used as an adjunct to diclofenac in patients undergoing lithotripsy?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Urological and Genital Diseases: Lithotripsy
Intervention	1. Pre treatment cream 2. No pre treatment cream
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ametop
Primary outcome measure(s)	Visual analogue score of pain and measure of maximum shock intensity achieved during treatment session
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2003
Date of final enrolment	31/07/2007

Department of Urology and Nephrology

London
W1P 7PN
United Kingdom

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