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IRCT20210911052441N1 IRCT 2025-06-23 Kashan University of Medical Sciences Levetiracetam versus Clobazam for prophylaxis of febrile seizures Levetiracetam versus Clobazam for prophylaxis of febrile seizures in children 2021-02-19 anticipated 80 Complete https://irct.ir/trial/59213 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization was performed using a random number table based on the sample size obtained by the software. Odd numbers were assigned to the clobazam group and even numbers to levetiracetam, and accordingly, the patients were divided into two groups of 40 each, receiving clobazam and levetiracetam. Treatment was prescribed to the patients by a pediatric neurologist. 3 Febrile convulsion. Intervention 1: Intervention group: Levetiracetam: Levetiracetam syrup 30mg/Kg per dose, used for 48 hours after the onset of fever. This syrup is drawn up with a syringe according to the dose and given to the child. Intervention 2: Intervention group: Clobazam, Clobazam tablets at a dose of 1mg/Kg, were used for 48 hours after the onset of fever. The tablets were dissolved in water according to the dose and fed to the child. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Fatemeh Zamanian
5th of Qotb –e Ravandi Blvd. P.O.Box: 87159.1151, Kashan, IRAN
Kashan Iran (Islamic Republic of) 87159.1151 +98-31-55540026-31 zamanyan-f@kaums.ac.ir Kashan University of Medical Sciences scientific Fatemeh Zamanyan
Shahid Beheshti hospital, Hekmat 56 St.,Ghotb-e Ravandi Blvd.,Kashan, Iran
Kashan Iran (Islamic Republic of) 87159.1151 +98 31 5541 3316 dr.fa_zamanyan@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Children with febrile seizures 6 months 6 years Both Neurologic disease Metabolic disorder epilepsy trauma meningitis R56.0 Febrile convulsions Prevention Prevention Intervention group: Levetiracetam: Levetiracetam syrup 30mg/Kg per dose, used for 48 hours after the onset of fever. This syrup is drawn up with a syringe according to the dose and given to the child. Intervention group: Clobazam, Clobazam tablets at a dose of 1mg/Kg, were used for 48 hours after the onset of fever. The tablets were dissolved in water according to the dose and fed to the child. Number of febrile seizure recurrences in treated children. Timepoint: One year later. Method of measurement: Oral questionnaire. Kashan University of Medical Sciences Approved 2021-01-26 Ethics committee of kashan University of Medical Sciences Shahid Beheshti Hospital, Ghotb-e Ravandi Blvd., Kashan, Iran Kashan Isfehan Iran (Islamic Republic of)