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

Febrile Seizures Clinical Trial

Official title:

Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631901
• Other study ID #: TU2017
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: September 2019
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Febrile Seizures
• Fever
• Seizures
• Seizures, Febrile

Intervention

Drug:
• oral melatonin
Both melatonin and diazepam were given only during the febrile illness.
• oral diazepam
Both melatonin and diazepam were given only during the febrile illness.

Locations

Country	Name	City	State
Egypt	Tanta University, Faculty of Medicine	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of febrile seizures during febrile illness		6 months
Secondary	side effect of medications reported in children		6 months