Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Pruritus |
| Intervention | Drug: Gabapentin |
| Phase | Phase 1 |
| Sponsor | The Hospital for Sick Children |
| Responsible Party | The Hospital for Sick Children |
| ClinicalTrials.gov Identifier | NCT01092520 |
| First Received | March 23, 2010 |
| Last Updated | August 19, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 23, 2010 |
|---|---|
| Last Updated Date | August 19, 2013 |
| Start Date | July 2009 |
| Estimated Primary Completion Date | July 2011 |
| Current 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 |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children |
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| 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 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 |
| Study Phase | Phase 1 |
| Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Pruritus |
| Intervention | 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. |
| Study Arm (s) | Experimental: Gabapentin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Withdrawn |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | July 2011 |
| Estimated Primary Completion Date | July 2011 |
| Eligibility 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 |
| Gender | Both |
| Ages | 6 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01092520 |
|---|---|
| Other Study ID Numbers | 1000013007 |
| Has Data Monitoring Committee | No |
| Information Provided By | The Hospital for Sick Children |
| Study Sponsor | The Hospital for Sick Children |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Jason Hayes, MD The Hospital for Sick Children |
| Verification Date | August 2013 |
Locations[ + expand ][ + ]
| The Hospital for Sick Children | Toronto, Ontario, Canada |
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