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

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01092520
• Other study ID #: 1000013007
• Status: Withdrawn
• Phase: Phase 1
• First received: March 23, 2010
• Last updated: August 19, 2013
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Pruritus

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of Life Score	Measured by the Children's Dermatology Quality Index	Daily until discharge	No
Secondary	Antihistamine use		Daily until discharge or cessation of antihistamines	No
Secondary	Opioid Consumption		Daily until discharge or cessation of opioid intake	No