Efficacy of Intermittent Oral Levetiracetam Vs Clobazam in preventing seizure recurrence in children with Febrile Seizure: A Randomized Controlled Trial

INTRODUCTION: Febrile seizure is the most common seizure associated among paediatric subjects. The recurrence of febrile seizure depends on many factors including the treatment. OBJECTIVES: The study aimed to find out seizure frequency associated with febrile events and febrile seizure recurrence rate during 48 weeks follow-up in paediatric subjects treated with oral levetiracetam vs clobazam group. METHODOLOGY: The study was an Open labelled Randomised controlled trial conducted among paediatric subjects with febrile seizure history of two or more episodes of febrile seizures within the last 6 months, atleast 1 seizure recurrence within the last 2 weeks and onset of age between 6 months and 5 years. Subjects with episodes of previous seizures without fever, intracranial infections, head trauma, current use of anti-epileptic drugs were excluded from the study. The subjects selected were randomly divided into 2 groups. One group got oral paracetamol 15mg/kg/dose at the onset of fever till fever subsides plus oral levetiracetam at a dose of 15-30 mg/kg/day twice daily at the onset of fever(temperature >37.5 c) for 1 week followed by dose tapering of 50% every 2 days until complete withdrawal at the second week. Second group received oral paracetamol 15mg/kg/dose at the onset of fever till fever subsides plus oral clobazam 0.75mg/kg/day in two divided doses for 3 days. Children were followed up for 48 weeks to find out seizure frequency associated with febrile events and febrile seizure recurrence rate during 48 week follow-up. The data was entered into Microsoft excel and analysed using SPSS 21. RESULTS: The mean (SD) of age in months among the subjects was 33.6 (10) months. The levetiracetam group had a mean (SD) of 34.85 (11.13) months and that of clobazam group was 32.41 (8.75) months respectively. Among the levetiracetam group 32(59.3%) were males and 22 (40.7%) were females. Among the clobazam group 28 (51.9%) were males and 26 (48.1%). The febrile episode distribution among the groups showed the mean (SD) of febrile episodes among levetiracetam group was 3.61(1.46) and that of clobazam group was 3.48 (1.99). The levetiracetam group showed that 23 (42.6%) had a single febrile seizure episode and 15 (27.8%) among clobazam group had single episode of seizure. The association of febrile episodes and recurrence of febrile seizures among the group shows no significant association among the groups on febrile episodes. The febrile seizure recurrence showed that clobazam group had lesser recurrence in comparison to levetiracetam [single episode 15 (39.5%) vs. 23 (60.5%)]. The association of febrile seizure recurrence with age of onset, gender and family history of seizure showed that no significant association was found between the variables. CONCLUSION: The study showed that clobazam showed effectiveness in reducing febrile seizure recurrence among the subjects in comparison to levetiracetam