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

Phase 1

Withdrawn

• Conditions: Pruritus
• Interventions: Drug: Gabapentin

• Registration Number: NCT01092520
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gabapentin	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada