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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 maneuvers

Frequency 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

Page last updated: August 23, 2015

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