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

Primary Purpose

Pruritus

Status
Withdrawn
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring Gabapentin, Burn Injuries in Children, pruritus

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gabapentin

Arm Description

Outcomes

Primary Outcome Measures

Pruritus score
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

Quality of Life Score
Measured by the Children's Dermatology Quality Index
Antihistamine use
Opioid Consumption

Full Information

First Posted
March 23, 2010
Last Updated
August 19, 2013
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01092520
Brief Title
Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children
Official Title
Open Label Pilot Study of Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Withdrawn
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
Keywords
Gabapentin, Burn Injuries in Children, pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pruritus score
Description
4-point scale validated in children 6 to 18 years of age, with additional descriptors from a similar scale used in adults
Time Frame
Daily until discharge
Secondary Outcome Measure Information:
Title
Quality of Life Score
Description
Measured by the Children's Dermatology Quality Index
Time Frame
Daily until discharge
Title
Antihistamine use
Time Frame
Daily until discharge or cessation of antihistamines
Title
Opioid Consumption
Time Frame
Daily until discharge or cessation of opioid intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Hayes, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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

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