Pruritus
Conditions
Keywords
Gabapentin, Burn Injuries in Children, pruritus
Brief 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.
Detailed description
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.
Interventions
DRUGGabapentin
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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus score | Daily until discharge | 4-point scale validated in children 6 to 18 years of age, with additional descriptors from a similar scale used in adults |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Score | Daily until discharge | Measured by the Children's Dermatology Quality Index |
| Antihistamine use | Daily until discharge or cessation of antihistamines | — |
| Opioid Consumption | Daily until discharge or cessation of opioid intake | — |
Countries
Canada
Outcome results
None listed