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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Experimental |
| |
| Oxcarbazepine | Experimental |
| |
| Placebo | Placebo Comparator | Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Patients will be randomized to receive either Gabapentin or Oxcarbazepine. The assignment of the medications will be randomized and blinded to both the study investigators and the patient. If patients exhibit >30% pain reduction on receiving the medication evaluated after 4 weeks, then they may continue to receive either the same medication or placebo. If patients exhibit <30% pain reduction, the patient will crossover to the other medication option in the protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| As a primary outcome, success will be defined by clinically and statistically significant within subject reductions in pain scores |
| 0 (baseline), 2, 4, 6, 8 weeks (post-assignment of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores at rest and evoked maneuvers | The investigators will assess pain scores at rest and with evoked maneuvers through exam and quantitative sensory test. | 0 (baseline) and 4 and 8 weeks (post assignment of intervention) |
| Frequency of side effects- Tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monique Ribeiro, MD | Contact | (617) 355-7040 | Monique.Ribeiro@childrens.harvard.edu | |
| Kimberly Lobo, MPH | Contact | (857) 218-3556 | Kimberly.Lobo@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Monique Ribeiro, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
| Oxcarbazepine | Drug | Patients will be randomized to receive either Gabapentin or Oxcarbazepine. The assignment of the medications will be randomized and blinded to both the study investigators and the patient. If patients exhibit >30% pain reduction on receiving the medication evaluated after 4 weeks, then they may continue to receive either the same medication or placebo. If patients exhibit <30% pain reduction, the patient will crossover to the other medication option in the protocol. |
|
| Placebo | Other | Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs. |
|
Routine laboratory testing will be conducted as part of the safety profile assessment. |
| 1, 2, 4, 6, 8 weeks (post assignment of intervention) |
| Functional Disability Scores | 0 (baseline), 4, and 8 weeks (post-assignment of intervention) |
| Frequency of Side effects- Depression and Anxiety | As both study medicines may be associated with mood changes and as pain itself sometimes is co-morbid with anxiety and depression, the investigators will perform self-report measures of anxiety and depression (Children's Depressive Inventory and The Revised Children's Manifest Anxiety Scale) pre and post-assigment of the intervention. | Baseline, Week 4 and 8 (post assignment of the intervention) |
| Frequency of Side Effects- Neuropsychological Measures | Both study medicines may be associated with the emergence of cognitive side effects to include difficulties with concentration and cognitive slowing. The investigators will assess for cognitive processing speed, working memory and attention difficulties during the course of treatment using the NIH toobox Cognitive Battery. | Baseline, weeks 4 and 8 (post-assignment of the intervention). |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |