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 |
| Protocol serial number | N0205134575 |
| Sponsor | Department of Health |
| Funder | Barts and The London NHS Trust (UK) |
- 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
Scientific
Plastic Surgery
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Plastic Surgery
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
