Chronic Pain Clinical Trial
Official title:
A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children
This study is a prospective, randomized, double blind, placebo controlled, crossover clinical trial looking at whether gabapentin can provide symptom relief for chronic irritability in neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and safe for children with chronic irritability that persists despite identification and appropriate management of symptom sources.
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 Checklist-Revised,
to be completed by their parent or primary caregiver.
The primary aim is to determine if gabapentin provides symptom relief for chronic
irritability in neurologically impaired children.
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