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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Jason Hayes, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01092520
First received: March 23, 2010
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Pruritus
Drug: Gabapentin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Pilot Study of Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Pruritus score [ Time Frame: Daily until discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily until discharge ] [ Designated as safety issue: No ]
    Measured by the Children's Dermatology Quality Index

  • Antihistamine use [ Time Frame: Daily until discharge or cessation of antihistamines ] [ Designated as safety issue: No ]
  • Opioid Consumption [ Time Frame: Daily until discharge or cessation of opioid intake ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin 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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092520

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Jason Hayes, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Jason Hayes, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01092520     History of Changes
Other Study ID Numbers: 1000013007
Study First Received: March 23, 2010
Last Updated: August 19, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Gabapentin
Burn Injuries in Children
pruritus

Additional relevant MeSH terms:
Burns
Pruritus
Wounds and Injuries
Skin Diseases
Skin Manifestations
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on August 27, 2014