Determining the effectiveness of levetiracetam and clobazam on preventing recurrence of febrile convulsion
Design
Clinical trial, two-arm, parallel-group, unblinded, randomized in a sequential manner Phase 3 on 80 patients, 40 patients in each group
Settings and conduct
Patients are divided into two groups. In each group, one of the drugs levetiracetam or clobazam is prescribed to prevent Febrile convulsion in febrile illnesses in the next year. Recurrence of febrile seizures in the next year in each group is assessed.
Participants/Inclusion and exclusion criteria
Children with febrile convulsion without neurologic diseases and metabolic disorders
Intervention groups
The clobazam group and the levetiracetam group, each group taking the drug for a specific days after fever starts and the recurrence of febrile convulsion in the next year are evaluated.
Main outcome variables
Incidence of febrile convulsion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210911052441N1
Registration date:2025-06-23, 1404/04/02
Registration timing:retrospective
Last update:2025-06-23, 1404/04/02
Update count:0
Registration date
2025-06-23, 1404/04/02
Registrant information
Name
Fatemeh Zamanyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5541 3316
Email address
zamanyan-f@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
2021-03-25, 1400/01/05
Actual recruitment end date
2021-11-09, 1400/08/18
Trial completion date
2022-11-11, 1401/08/20
Scientific title
Levetiracetam versus Clobazam for prophylaxis of febrile seizures in children
Public title
Levetiracetam versus Clobazam for prophylaxis of febrile seizures
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kashan University of Medical Sciences
Number of febrile seizure recurrences in treated children
Timepoint
One year later
Method of measurement
Oral questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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.