Status:
NOT_YET_RECRUITING
Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study
Lead Sponsor:
Boston Children's Hospital
Conditions:
Pediatric Chronic Neuropathic Pain
Eligibility:
All Genders
8-18 years
Phase:
PHASE3
Brief Summary
Given the widespread use of anticonvulsants in the pediatric chronic pain population and the absence of scientific data supporting their use, the investigators propose a randomized, double blind, two ...
Eligibility Criteria
Inclusion
- Patients between the ages of 8 and 18 at the time of the study with history of chronic (lasting ≥ 4 weeks) neuropathic pain that includes a known injury to a peripheral nerve and/or a pattern of pain responses that includes allodynia, burning, paresthesias or dysesthesias will be included in this study, provided that informed consent has been given by parents.
- Patient's whose pain rates between moderate to severe at the time of inclusion (ranging from 4-10 in a numeric pain rating scale)
- Eligible diagnoses include Complex Regional Pain Syndrome, Fibromyalgia, Lumbar Radiculopathy, Spinal Cord Injury, Erythromelalgia, Small Fiber Neuropathies, Traumatic or Post-surgical Peripheral Nerve or Plexus Injuries, and Extremity Pain with severe pain to light touch (allodynia).
- Child has age-appropriate spoken and written knowledge of English.
- Parent may be able to utilize an interpreter if need be.
Exclusion
- Unstable psychiatric illness (suicidal ideation, disorganized behavior)
- Uncontrolled Seizure disorder
- Chronic Headaches only
- Abdominal Pain only
- Prior experience with anticonvulsants for pain treatment.
- Patients with Syndrome of Inappropriate Secretion of Antidiuretic Hormone
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02219373
Start Date
October 1 2024
End Date
December 1 2026
Last Update
August 16 2024
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115