Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children
Children with healing burns often suffer from pruritus that may continue for many months. Pruritus can be very distressing to the child and can interfere with sleep, activities of daily living, and rehabilitation therapy. Additionally, constant scratching of skin grafts may result in damage that requires further surgery, thus putting the patient at additional risk and adding to health care costs. Although the size of the burn injury is a risk factor for pruritus, almost 50% of patients with small burn injuries reported moderate or severe pruritus.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Pilot Study of Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children|
- Pruritus score [ Time Frame: Daily until discharge ] [ Designated as safety issue: No ]4-point scale validated in children 6 to 18 years of age, with additional descriptors from a similar scale used in adults
- Quality of Life Score [ Time Frame: Daily until discharge ] [ Designated as safety issue: No ]Measured by the Children's Dermatology Quality Index
- Antihistamine use [ Time Frame: Daily until discharge or cessation of antihistamines ] [ Designated as safety issue: No ]
- Opioid Consumption [ Time Frame: Daily until discharge or cessation of opioid intake ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||July 2011|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Day 1 - 5mg/kg/dose per os at bedtime then 5mg/kg/dose PO b.i.d x 1 day (Day 2) then on Day 3, 5mg/kg/dose PO t.i.d . x 19 days; after 7 days, if not at maximal effect may increase over 3 days to 10mg/kg/dose (Day 8: 5 mg/kg/dose q.am and midday, Day 9: 10mg/kg/dose b.i.d. + 5mg/kg/dose midday, Day 10: 10mg/kg/dose t.i.d.) Doses may be reduced if patient experiences intolerable side effects.
Gabapentin has been shown to be effective for the treatment of pruritus in adult patients with brachioradial pruritus, uraemic pruritus and pruritus of unknown origin. Although the specific mechanism is unknown, the end result is the downregulation of excitatory neurotransmitter release and decrease in neuronal hyperexcitability.
The primary objective of this study is evaluating the effectiveness of gabapentin in reducing the severity of pruritus in children with burn injuries.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092520
|The Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Principal Investigator:||Jason Hayes, MD||The Hospital for Sick Children|