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.|
|ClinicalTrials.gov Identifier: NCT01092520|
Recruitment Status : Withdrawn
First Posted : March 25, 2010
Last Update Posted : August 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pruritus||Drug: Gabapentin||Phase 1|
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)|
|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|
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.
- 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
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01092520
|The Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Principal Investigator:||Jason Hayes, MD||The Hospital for Sick Children|