Background: Febrile seizures (FS) are common in children and are associated with a high risk of recurrence. Even though several treatment options are available, no clear consensus has been established regarding the optimal prophylactic agent.
Objectives: This randomized clinical trial aimed to evaluate the efficacy and safety of levetiracetam (LEV) versus clobazam (CLB) in preventing recurrent FS in children aged 6–60 months.
Methods: This randomized, singleblind clinical trial was conducted among 69 children diagnosed with FS who were referred for treatment in 2024. Patients were randomly assigned to receive LEV or CLB and were followed for 9 months to assess recurrence of FS and drug-related side effects.
Results: The average age of the children was 23.77±13.31 months. No significant differences were found among groups in age, sex, family history of FS, or epilepsy (P>0.05). FS recurred in 5.9% of the CLB group and 5.7% of the LEV group (P>0.05). Mean number of recurrences per child was 0.54±0.12 in the CLB group and 0.37±0.09 in the LEV group, representing the average number of seizure episodes across the cohort (P>0.05). Adverse reactions occurred in 58.8% in the CLB group and 60% in the LEV group, primarily drowsiness, with no significant difference between groups (P>0.05).
Conclusions: Oral LEV and CLB demonstrate comparable effectiveness in reducing FS recurrence in children younger than 60 months, and have similar side effects. Treatment choice may be individualized based on patient factors.
نوع مطالعه:
Original Article |
دریافت: 1404/6/26 | پذیرش: 1405/1/14 | انتشار: 1405/1/14