Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

Launched by GILLETTE CHILDREN'S SPECIALTY HEALTHCARE · Aug 29, 2012

Keywords

ClinConnect Summary

This is a randomized, placebo-controlled, cross-over study design of the effects of gabapentin on chronic irritability in neurologically impaired children. The study will involve a 22 day medication titration, followed by a 7 day stable dosing period and a 6 day medication taper period. After an additional 3 day washout period, the subject will cross-over to the remaining arm of the study. Subjects will be evaluated for symptoms of chronic pain. Since the subjects are generally non-communicative, the subjects will be evaluated by two questionnaires and the Non-Communicating Children's Pain ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • male or female
• • 1 month to 16 years of age at enrollment
• • neurological impairment defined as subnormal (-2 S.D.) motor and/or cognitive ability from a variety of etiologies
• • chronic irritability defined as symptoms suggesting pain to the child's caregiver recurrently over a 4-week of greater time period
• • Subject must have an acceptable surrogate capable of giving consent on the subject's behalf
• Exclusion Criteria:
• • Children with resolved symptoms after treatment of identified sources of pain
• • Identified potential source of irritability without adequate trial of appropriate management
• • Ketogenic diet
• • Renal insufficiency or failure
• • Current treatment with gabapentin or pregabalin for another existing condition.