A Phase 1 interventional study of Gabapentin in Pruritus, sponsored by The Hospital for Sick Children. Withdrawn at 1 site in Canada. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-08-20.
Sponsored by The Hospital for Sick Children · Phase 1, Interventional, and Treatment
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.
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.
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
Browse Pruritus studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Drug: Gabapentin
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.
Pruritus score
4-point scale validated in children 6 to 18 years of age, with additional descriptors from a similar scale used in adults
Time frame: Daily until discharge
Quality of Life Score
Measured by the Children's Dermatology Quality Index
Time frame: Daily until discharge
Antihistamine use
Time frame: Daily until discharge or cessation of antihistamines
Opioid Consumption
Time frame: Daily until discharge or cessation of opioid intake
This study is withdrawn, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children