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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Open Label Pilot Study of Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in 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 Summary:

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.


Sponsor: The Hospital for Sick Children

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of Life Score [ Time Frame: Daily until discharge ]
    Measured by the Children's Dermatology Quality Index
  • Antihistamine use [ Time Frame: Daily until discharge or cessation of antihistamines ]
  • Opioid Consumption [ Time Frame: Daily until discharge or cessation of opioid intake ]


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: March 23, 2010
Date Started: July 2009
Date Completion: July 2011
Last Updated: August 19, 2013
Last Verified: August 2013