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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01092520
Recruitment Status : Withdrawn
First Posted : March 25, 2010
Last Update Posted : August 20, 2013
Information provided by (Responsible Party):
Jason Hayes, 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.

Condition or disease Intervention/treatment Phase
Pruritus Drug: Gabapentin Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Pilot Study of Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children
Study Start Date : July 2009
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Itching
U.S. FDA Resources

Arm Intervention/treatment
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 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 Measures :
  1. Pruritus score [ Time Frame: 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 :
  1. Quality of Life Score [ Time Frame: Daily until discharge ]
    Measured by the Children's Dermatology Quality Index

  2. Antihistamine use [ Time Frame: Daily until discharge or cessation of antihistamines ]
  3. Opioid Consumption [ Time Frame: Daily until discharge or cessation of opioid intake ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01092520

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

Responsible Party: Jason Hayes, Staff Anesthesiologist, The Hospital for Sick Children Identifier: NCT01092520     History of Changes
Other Study ID Numbers: 1000013007
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013

Keywords provided by Jason Hayes, The Hospital for Sick Children:
Burn Injuries in Children

Additional relevant MeSH terms:
Skin Diseases
Skin Manifestations
Signs and Symptoms
Wounds and Injuries
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents