Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study
Information source: Children's Hospital Boston
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Chronic Neuropathic Pain
Intervention: Gabapentin (Drug); Oxcarbazepine (Drug); Placebo (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Children's Hospital Boston Official(s) and/or principal investigator(s): Monique Ribeiro, MD, Principal Investigator, Affiliation: Children's Hospital Boston
Overall contact: Monique Ribeiro, MD, Phone: (617) 355-7040, Email: Monique.Ribeiro@childrens.harvard.edu
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 group parallel design in which a broad group of children and adolescents
with chronic neuropathic pain would be randomized to receive either Gabapentin or
Oxcarbazepine.
The Primary Aim of the Study is to assess the frequencies of successful treatment of
pediatric patients with neuropathic pain treated with either Gabapentin or Oxcarbazepine.
The Primary Hypotheses are as follows:
Hypothesis I: Both Gabapentin and Oxcarbazepine will result in significant reduction in
pain scores when compared to each patient's baseline.
Hypothesis II: Patients who continue on active drug (Gabapentin or Oxcarbazepine) during
the second phase of the trial will report greater pain reduction relative to baseline than
patients who are randomized onto placebo at this randomization point.
Secondary Aims of the Study are to compare groups treated initially with Gabapentin or
Oxcarbazepine with regard to reduction in pain scores (both at rest and with evoked
maneuvers), functional disability scores, tolerability, and measures of mood and cognitive
functioning.
Secondary Hypotheses are that Gabapentin and Oxcarbazepine differ in their effects on:
1. Pain scores at rest and with evoked maneuvers
2. Functional disability scores
3. Tolerability (frequencies of side-effects)
4. Depression and anxiety scales
5. Neuropsychological measures of cognitive processing speed, working memory, and
attention.
Clinical Details
Official title: Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Double-Blind, Randomized Clinical Effectiveness Study.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: As a primary outcome, success will be defined by clinically and statistically significant within subject reductions in pain scores
Secondary outcome: Pain Scores at rest and evoked maneuversFrequency of side effects- Tolerability Functional Disability Scores Frequency of Side effects- Depression and Anxiety Frequency of Side Effects- Neuropsychological Measures
Eligibility
Minimum age: 8 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.
2. Patient's whose pain rates between moderate to severe at the time of inclusion
(ranging from 4-10 in a numeric pain rating scale)
3. 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).
4. Child has age-appropriate spoken and written knowledge of English.
5. Parent may be able to utilize an interpreter if need be.
Exclusion Criteria:
1. Unstable psychiatric illness (suicidal ideation, disorganized behavior)
2. Uncontrolled Seizure disorder
3. Chronic Headaches only
4. Abdominal Pain only
5. Prior experience with anticonvulsants for pain treatment.
6. Patients with Syndrome of Inappropriate Secretion of Antidiuretic Hormone
Locations and Contacts
Monique Ribeiro, MD, Phone: (617) 355-7040, Email: Monique.Ribeiro@childrens.harvard.edu
Boston Children's Hospital, Boston, Massachusetts 02115, United States; Not yet recruiting Monique Ribeiro, MD, Principal Investigator
Additional Information
Starting date: October 2014
Last updated: August 15, 2014
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