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

Tanta University

Status and phase: Completed; Phase 4

Conditions: Febrile Seizures

Treatments: Drug: oral diazepam; Drug: oral melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT03631901

TU2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Melatonin

Active Comparator group

Description:

melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness.

Treatment:

Drug: oral melatonin

Diazepam

Active Comparator group

Description:

oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness.

Treatment:

Drug: oral diazepam