Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Open Label Pilot Study of Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children

Conditions
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Pruritus

Intervention / Treatment
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* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with partial or deep thickness burn Children receiving triple antihistamines for treatment of pruritus Children with a pruritus score ≥ 2 (Appendix 1) despite triple antihistamine therapy Children who are tolerating liquids by mouth or nasogastric tube Exclusion Criteria Children with a medical condition for which gabapentin is contraindicated including children who have demonstrated a hypersensitivity to gabapentin or any of the components of the formulation. Children with seizure disorders Children with a pre-existing behavioural or developmental disorder Children with renal impairment Children with severe burns requiring PICU admission

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br> | Drug: Gabapentin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus score | 4-point scale validated in children 6 to 18 years of age, with additional descriptors from a similar scale used in adults | Daily until discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Score | Measured by the Children's Dermatology Quality Index | Daily until discharge | 
| Antihistamine use |  | Daily until discharge or cessation of antihistamines | 
| Opioid Consumption |  | Daily until discharge or cessation of opioid intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gabapentin, Burn Injuries in Children, pruritus