Overview

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

Status:
Withdrawn
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Hospital for Sick Children
Treatments:
Gabapentin
gamma-Aminobutyric Acid
Criteria
Inclusion Criteria:

1. Children with partial or deep thickness burn

2. Children receiving triple antihistamines for treatment of pruritus

3. Children with a pruritus score ≥ 2 (Appendix 1) despite triple antihistamine therapy

4. Children who are tolerating liquids by mouth or nasogastric tube

Exclusion Criteria

1. 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.

2. Children with seizure disorders

3. Children with a pre-existing behavioural or developmental disorder

4. Children with renal impairment

5. Children with severe burns requiring PICU admission