A RANDOMIZED CONTROLLED TRIAL TO COMPARE EFFICACY OF ORAL CLOBAZAM WITH ORAL DIAZEPAM FOR PROPHYLAXIS OF FEBRILE SEIZURES

Objectives: Objectives: To compare the efficacy of intermittent prophylaxis with oral clobazam versus oral diazepam in children with febrile seizures.

Methods: Methods: 150 children aged 6–60 months (during October 2000- December 2003), with one or more episodes of febrile seizure were studied. Children with neurological abnormalities, a febrile seizures and other symptomatic seizures were excluded. They were randomized into: Group 1: Oral diazepam 0.3mg/kg/dose every 8hrs for 3 days; Group 2: Oral clobazam 1mg/kg/day for 3 days. Drugs were administered during each febrile episode. Antipyretics and hydrotherapy were advised to both groups. Child was unit of randomization and febrile episode was unit of analysis. Bivariate analysis and multivariate logistics regression analysis using Generalized Estimating Equation approach were performed.

Results: Results: The basal characteristics of the two groups were similar. The median follow-up duration was 10 months. 135 children (90%) had febrile episodes, 65 (86.7%) in diazepam group, and 70 (93.3%) in clobazam group. A total of 559 febrile episodes (254 diazepam group, and 305 clobazam group) were recorded, non-compliance was recorded for 13% febrile episodes in diazepam group and 16% in clobazam group. Sedation was noticed to be more in the clobazam group (p=0.007). The odds ratio of seizure recurrence in the diazepam group was 2.3 as compared to clobazam group. The febrile seizure recurrence during fever episodes adequately treated was 11.3% in the diazepam group, and 3.1% in clobazam group (p=0.0004).

Conclusion: Conclusions: Oral clobazam was found to be more effective in preventing febrile seizure recurrence as compared to diazepam besides convenience of a single oral dose.