Intermittent clobazam prophylaxis in simple febrile convulsions: a randomised controlled trial


  • Vinod Kumar Department of Pediatrics, Dr. S. N. Medical College, Jodhpur, Rajasthan, India
  • Ashish Gupta Department of Pediatrics, Dr. S. N. Medical College, Jodhpur, Rajasthan, India



Febrile convulsions, Febrile seizure recurrence, Fever, Intermittent oral clobazam therapy


Background: Febrile seizure (FS) is the most common type of childhood seizure disorder with a prevalence of 2-5% in children less than 5 years. Although the prognosis of febrile seizure is usually good, however, the possibility of recurrence keeps many parents and families in a state of anxiety and concerned, for years after the first seizure. Thus, intermittent prophylactic treatment might be advised in children with high risk of recurrence.

Methods: The study was a prospective randomized, double blind, placebo-controlled trial conducted at Department of Pediatrics, Umaid Hospital, Dr S N Medical College, Jodhpur on neurologically normal children aged from 6 months to 5 years with a history of simple febrile seizures and normal electroencephalogram without any evidence of acute central nervous system infection. Subjects were randomly prescribed oral clobazam according to weight of child and placebo when they developed a febrile disease during the first 48 h of the onset of fever.  Temperature reduction measures with paracetamol and tepid sponging were also advised. Patients were followed up for the frequency and time of febrile seizure recurrence, febrile episodes and side effects of drugs for 12 months.

Results: Ten (3.8%) of 257 episodes in clobazam group and 38 (14.07%) episodes in placebo group had seizure recurrence (p value <0.001). The two groups were not significantly different in terms of side effects. (p >0.05).

Conclusions: Intermittent oral clobazam therapy is a very effective measure in preventing recurrence of febrile seizures.


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