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Comparison between Phenobarbital and Topiramate in prevention of relapse of febrile seizure in patients aged 6months to 5 years suffering from Febrile Convulsion

Comparison between Phenobarbital and Topiramate in prevention of relapse of febrile seizure in patients aged 6months to 5 years suffering from Febrile Convulsion

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013120710087N3
Enrollment
140
Registered
2014-05-09
Start date
2011-12-11
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Convulsions. Febrile convulsions

Interventions

Intervention 1: Intervention group : The patients in the intervention group take 5 mg per kg oral Topiramate per day for a year. To ensure proper use of the drug, the patient is asked to visit the cli
Treatment - Drugs
Intervention group : The patients in the intervention group take 5 mg per kg oral Topiramate per day for a year. To ensure proper use of the drug, the patient is asked to visit the clinic again after
Control group: The patients in the control group take 5 mg per kg oral phenobarbital in two divided doses per day for a year. To ensure proper use of the drug, the patient is asked to visit the clinic

Sponsors

Zahedan University of Medical Sciense
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients aged 6 months to 5 years suffering from febrile convulsion; if the first febrile convulsion occurs under 1 year of age; positive family history of febrile convulsion in first-degree relatives; low grade fever during the first attack (less than 39 °C); short period of time between the onset of fever and convulsion; multiple attacks of seizure; if the first febrile convulsion is complex. Exclusion criteria: patients who have clinical or radiographic signs due to chronic mental disease (MR); patients who were diagnosed with meningitis considering the LP; patients whose seizure caused by electrolyte imbalance; history of a seizure without high temperature; patients who received prophylaxis treatment; patients who developed side effect due to receiving Topiramate.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Decreasing the relapse of Febrile Convulsion. Timepoint: After one year. Method of measurement: Clinical assessment.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ali Khaje

Zahedan University of Medical Science

khajeha@zaums.ac.ir+98 54 1341 1260

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026