ISRCTN ISRCTN23032360
DOI https://doi.org/10.1186/ISRCTN23032360
Protocol serial number N0234117600
Sponsor Department of Health (UK)
Funder North Bristol NHS Trust (UK)
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

Department of Anaesthetics
North Bristol NHS Trust
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom

Phone +44 (0)117 970 1212
Email janine.mendham@north-bristol.swest.nhs.uk

Study information

Primary study designInterventional
Study designRandomised placebo controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesDoes 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) studiedItching
Intervention50 children with itching causing distress following a burn will be randomized and receive placebo or 5 mg/kg gabapentin.
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Gabapentin
Primary outcome measure(s)

Reduction of itching.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/11/2003

Eligibility

Participant type(s)Patient
Age groupChild
SexAll
Target sample size at registration50
Key inclusion criteriaChildren admitted to the Childrens Ward with burns who are distressed by itching.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/11/2002
Date of final enrolment01/11/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Anaesthetics
Bristol
BS16 1LE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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