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Study aim
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The aim of this study was to compare the frequency of seizures, duration of seizures, possible complications, improvement of behavioral disorder and sleep cycle disorder before and after treatment with melatonin and placebo in intervention and control groups
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Design
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The study design is clinical trial with a control group, with parallel groups, single blind and simple randomization and patients will be studied in two groups of 25 cases.
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Settings and conduct
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In this clinical trial, children referred to the pediatric neurology clinic of BouAli Hospital in Sari are examined. Patients are blind and will be evaluated by simple random sampling
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Participants/Inclusion and exclusion criteria
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Children from 1 to 21 years with seizures who have not been controlled with at least three different antidepressants and who have had at least four or more seizures a month before the study are included. Exclusion criteria are unrepeatable seizures, history of cardiovascular and neurodegenerative syndromes, liver and kidney dysfunction, history of pseudo seizures, blindness, lack of compliance (irregular drug use, unreliable parenting, severe and persistent progressive seizures), and a history of vasculitis.
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Intervention groups
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The intervention group will be prescribed melatonin tablet at a dose of 10 mg/m2 body surface area in the form of a 3 mg tablet manufactured by Razak Pharmaceuticals. In the control group, placebo with the combination of tricalcium phosphate, magnesium stenarate and starch adhesive is also given with a similar shape, color and taste. Patients will take the pills daily and one hour before bedtime (along with their anticonvulsants) for 4 weeks.
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Main outcome variables
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The main outcomes of the study are treatment response rate including seizure frequency, duration of seizure, possible complications, improvement of behavioral disorder and sleep cycle disorder before and after the treatment.