Condition category
Skin and Connective Tissue Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
25/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr C Nduka

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205134575

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2003

Overall trial end date

01/04/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/10/2003

Recruitment end date

01/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Plastic Surgery
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Barts and The London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14615270

Publication citations

  1. Results

    Nduka C, van Dam H, Davis K, Shibu M, Painless steroid injections for hypertrophic scars and keloids., Br J Plast Surg, 2003, 56, 8, 842.

Additional files

Editorial Notes