A randomised controlled trial of pain experienced during the injection of intralesional steroid with or without prior cryoanalgesia

ISRCTN	ISRCTN63870786
DOI	https://doi.org/10.1186/ISRCTN63870786
Secondary identifying numbers	N0205134575

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 25/04/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr C Nduka
Scientific

Plastic Surgery
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Does cryoanalgesia reduce the pain associated with intralesional steroid injection? Cryoanalgesia is a well-documented technique for reducing pain preceding local anaesthetics by many years. However, the introduction of new anaesthetics and techniques, has reduced its use. Patients worry about steroid injections and one possibility is that of the pain caused by the injections. The aim of our study is to compare the pain experienced on steroid injection of the keloid scar, with and without prior cryoanalgesia.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Skin and Connective Tissue Diseases: Keloid scars
Intervention	A randomised prospective clinical trial. Subjects: patients who are scheduled for intralesional injection of their keloid scars Methods: patients to be randomised into two groups to either receive application of ice pack or not, prior to steroid injection Results: does cryoanalgesia reduce the pain experienced on administration of the steroid injection?
Intervention type	Other
Primary outcome measure	A visual analogue scale will be completed to and after the steroid injection and the subjects will be asked to rate the pain experienced. Pain scores will then be compared between the groups.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/2003
Completion date	01/04/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients over the age of 18 who are scheduled to receive intralesional steroid injections as part of their treatment for keloid scarring. This will include patients within the Greater London Area.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/10/2003
Date of final enrolment	01/04/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Plastic Surgery

London
E1 1BB
United Kingdom

Sponsor information

Department of Health
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

Barts and The London 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?
Results article	results	01/12/2003		Yes	No