Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures

Phase 4CompletedNCT03631901

Tanta University60 enrolled

Overview

To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.

To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrence of simple febrile seizures in children aged 6 months to 5 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Febrile Seizures

Interventions

oral melatoninDRUG

Both melatonin and diazepam were given only during the febrile illness.

oral diazepamDRUG

Both melatonin and diazepam were given only during the febrile illness.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children aged 6 months to 5 yrs . * Simple febrile seizures Exclusion Criteria: * Complex febrile seizures * Child with history of neonatal seizure. * Afebrile seizures. * History of anticonvulsive therapy. * Children suffering from epilepsy. * Children with abnormal EEG. * Children with abnormal neurological examination. * Positive family history of epilepsy.

Locations (1)

Tanta University, Faculty of Medicine

Tanta, Egypt

Outcomes

Primary Outcomes

recurrence of febrile seizures during febrile illness

Time frame: 6 months

Secondary Outcomes

side effect of medications reported in children

Time frame: 6 months

Data from ClinicalTrials.gov

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