Intermittent Clobazam Therapy and Febrile Seizures Recurrence In Children Aged 6months To 6 Years– A Double-Blind Rct

Aims & Objectives: To measure the Relative Risk (RR) of recurrence of febrile seizures in intermittent clobazam vs placebo group Methods: A Double-blind randomized controlled trial. Randomization done using computer generated block randomization. Total 130 children from 6 months to 6 years of age with febrile seizures were enrolled with 65 in clobazam arm and 65 in placebo arm. All children were given clobazam orally 0.75 mg/kg/day twice daily for 72 hours from the onset of fever in intervention group and matching placebo in control group along with antipyretic therapy. Both groups were followed up for a period of 6 months. The patients were assessed on the basis of recurrence of seizure in clobazam and placebo group and the adverse effect of clobazam. Intention to treat analysis was used. Trial was started after CTRI registration and ethics clearance. Results: Mean age of participants was 32.7±17.8 months in clobazam group vs 30.3±18.4 months in the placebo group. There were 43(66.2%) males, 22(33.8%) females in clobazam group and 44(67.7%) males, 21(32.3%) females in placebo group. 9 patients (13.8%) in clobazam group and 12 patients (18.4%) in placebo group had seizure recurrence with a relative risk of 0.75(95% CI: 0.33 - 1.65, p>0.05) which was statistically insignificant. No patients in clobazam group experienced side effects like sedation or ataxia. Conclusions: Intermittent clobazam therapy is not effective in the prevention of recurrence of febrile seizures in agreement with the existing literature.