Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures
Study Details
Study Description
Brief Summary
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Melatonin melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness. |
Drug: oral melatonin
Both melatonin and diazepam were given only during the febrile illness.
|
Active Comparator: Diazepam oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness. |
Drug: oral diazepam
Both melatonin and diazepam were given only during the febrile illness.
|
Outcome Measures
Primary Outcome Measures
- recurrence of febrile seizures during febrile illness [6 months]
Secondary Outcome Measures
- side effect of medications reported in children [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Children aged 6 months to 5 yrs .
-
Simple febrile seizures
Exclusion Criteria:
-
Complex febrile seizures
-
Child with history of neonatal seizure.
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Afebrile seizures.
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History of anticonvulsive therapy.
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Children suffering from epilepsy.
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Children with abnormal EEG.
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Children with abnormal neurological examination.
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Positive family history of epilepsy.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tanta University, Faculty of Medicine | Tanta | Egypt |
Sponsors and Collaborators
- Tanta University
Investigators
- Principal Investigator: Amira Darwish, Tanta University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TU2017