Febrile Seizures
Conditions
Keywords
Melatonin, Diazepam, recurrence, prophylaxis, Febrile convulsions
Brief summary
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.
Detailed description
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.
Interventions
DRUGoral melatonin
Both melatonin and diazepam were given only during the febrile illness.
DRUGoral diazepam
Both melatonin and diazepam were given only during the febrile illness.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence of febrile seizures during febrile illness | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| side effect of medications reported in children | 6 months |
Countries
Egypt
Outcome results
None listed