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Comparison of clobazam and diazepam in preventing the recurrence of febrile seizures

Comparison of diazepam and clobazam in preventing the recurrence of febrile seizures in children aged 6 months to 5 years of age admitted to Kashan Shahid Beheshti Hospital

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014070318344N1
Enrollment
160
Registered
2014-09-23
Start date
2013-02-03
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 sizure. Febrile convulsions

Interventions

Intervention 1: Oral diazepam at a dose of 0.33 mg per kilogram of body weight per dose three times a day for 48 hours after the onset of fever. Intervention 2: Oral clobazam at a dose of 1 mg per kil
Treatment - Drugs
Oral diazepam at a dose of 0.33 mg per kilogram of body weight per dose three times a day for 48 hours after the onset of fever
Oral clobazam at a dose of 1 mg per kilogram of body weight per dose twice a day for 48 hours after the onset of fever

Sponsors

Vice Chancellor for research, Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 5 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children aged 6 months to 5 years with the first attack of febrile convulsion(rectal temperature greater than 38° C)/ Exclusion criteria: Patients who have CNS infection and/or acute electrolyte imbalance and a history of previous seizure in the absence of fever; lack of cooperation or loss to follow up( for example changing the place of living); parents' discontent to participate in the study; having an underlying neurological disorder.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Recurrence of febrile seizures. Timepoint: Every three months during the intervention in a period twelve months. Method of measurement: asking the parents and visit by the pediatric neurologist.

Secondary

MeasureTime frame
Drugs side effects. Timepoint: Every three months during the intervention in a period twelve months. Method of measurement: asking the parents and visit by the pediatric neurologist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shirin Vafaei

Kashan University of Medical Sciences

shirinvafaee@kaums.ac.ir+98 31 5554 0021

Outcome results

None listed

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