Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study

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.

Conditions

• Pediatric Chronic Neuropathic Pain

Interventions

DRUG

Gabapentin

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.

DRUG

Oxcarbazepine

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.

OTHER

Placebo

Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.

Sponsors & Collaborators

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Monique Ribeiro, MD · Boston Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

8 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations