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

NCT01092520 | Withdrawn Phase 1

• 1 other identifier: 1000013007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus

Keywords

Gabapentin; Burn Injuries in Children; pruritus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Quality of Life Score

  Daily until discharge

• Antihistamine use

  Daily until discharge or cessation of antihistamines

• Opioid Consumption

  Daily until discharge or cessation of opioid intake

Study Arms (1)

Gabapentin

EXPERIMENTAL

Drug: Gabapentin

Interventions

Gabapentin DRUG

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.

Gabapentin

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Pruritus

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jason Hayes, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 25, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 20, 2013

Record last verified: 2013-08

Locations

CA (1)