The control of itching due to wound healing by gabapentin in children
| ISRCTN | ISRCTN23032360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23032360 |
| Secondary identifying numbers | N0234117600 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 02/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J Mendham
Scientific
Scientific
Department of Anaesthetics
North Bristol NHS Trust
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
| Phone | +44 (0)117 970 1212 |
|---|---|
| janine.mendham@north-bristol.swest.nhs.uk |
Study information
| Study design | Randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Does gabapentin reduce itching when given to children with healing wounds - primary burn wounds? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Itching |
| Intervention | 50 children with itching causing distress following a burn will be randomized and receive placebo or 5 mg/kg gabapentin. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gabapentin |
| Primary outcome measure | Reduction of itching. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2002 |
| Completion date | 01/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | Children admitted to the Childrens Ward with burns who are distressed by itching. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 01/11/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthetics
Bristol
BS16 1LE
United Kingdom
BS16 1LE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
North Bristol 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 | 01/12/2004 | Yes | No |
