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

Phase 4

Completed

• Conditions: Febrile Seizures
• Interventions: Drug: oral melatonin; Drug: oral diazepam

• Registration Number: NCT03631901
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	oral melatonin	melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness.
Diazepam	oral diazepam	oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness.

Primary Outcome Measures

Name	Time	Method
recurrence of febrile seizures during febrile illness	6 months

Secondary Outcome Measures

Name	Time	Method
side effect of medications reported in children	6 months

Trial Locations

Locations (1)

Tanta University, Faculty of Medicine; 🇪🇬 Tanta, Egypt