Intermittent clobazam in febrile seizures: an Indian experience

 

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Abstract

The aim of this study is to find the efficacy and safety of intermittent clobazam in febrile seizures (FS). The study was a double blind placebo control trial. Sixty patients of age group 6 months to five years presenting with febrile seizures were finally randomized to clobazam (group A; n = 30; male/female: 14:16) and placebo (group B; n = 30; male/female: 17:13) groups after exclusion of mental retardation, congenital malformations, intracranial infections, renal or hepatic dysfunction or history of intake of antiepileptic drugs and afebrile seizures. The patients in group A were given intermittent prophylactic clobazam @0.75 mg/kg body weight twice daily and group B were given placebo, during the course of fever. Antipyretic (paracetamol) and cold sponging was advised to the guardian, if the fever exceeded 38°C. The patients were assessed primarily on the basis of recurrence of seizure per febrile episodes, pattern of seizures and safety from the adverse effects reported during the course of study and from the investigation done on the patient. The two groups had comparable clinical profile. Mean ages of patients in group A and B were 25.5 ± 13.38 and 18.43 ± 13.95 months, respectively. Thirteen cases in group A and 12 cases in group B had abnormal electroencephalogram at baseline. Five patients in group A and eight cases in group B had a family history of FS. Twenty seven patients in group A and 24 patients belonging to group B had generalized seizures at presentation whereas three and six patients presented with partial seizures at the time of enrolment in group A and B respectively. After treatment with clobazam seven and two patients had generalized and partial seizures respectively while the figures were 23 and 2 for group B patients. Thus, recurrence of FS was observed in 30% (nine) patients in group A and 83.3% (25) in group B, this difference was statistically significant. There were 151 and 161 febrile episodes during the course of study in group A and B, respectively, 0.139 seizures per febrile episodes were observed in group A after treatment with clobazam and 0.820 seizures per febrile episodes in the placebo group. There was a significant reduction in the frequency of seizures per febrile episode with clobazam as compared to placebo. The average number of seizures preceding six months was 4.33 ± 2.78 in the clobazam and, this declined significantly to 0.7 ± 1.37 (P < 0.001), while in the placebo group no decline in seizure frequency was observed. There was a significant prolongation of seizure free interval in group A treated with clobazam on comparison to placebo group. No significant adverse effect except irritability was observed in four patients on clobazam. Clobazam is efficacious and well tolerated as intermittent therapy for FS and is superior to the use of intermittent antipyretics alone.