Evaluation of intermittent Clobazam prophylaxis in children aged 6 months to 5 years with Complex Febrile Seizures already on continuous prophylaxis with Sodium Valproate ; a randomized control trial

Febrile seizures are the most common types of seizure among children, with aprevalence of 2–5% in children aged less than 5 years.

Most cases occur between 3 months and 5 years of age with peak age of 14–18 months. It accounts for approximately 25% of childhood status epilepticus

Febrile seizures frequently recur, with a recurrence rate of 50%, when the first attack occurs before one year of age. In general, one third of infants will develop a second attack following subsequent febrile illness; half of the latter group will experience a third febrile seizure as well. Febrile seizures recurs 3 or more times in 10% of cases

More than one half of recurrences are experienced during the first year and over 90% develop within two years, following the first attack, with the higher risk within the first 6 to 12 months.

The likelihood for recurrence is greater among infants who convulse at temperatures below 40°C. The risk of recurrence is about 30% for simple febrile seizures and over 50% for complex febrile seizures.

Treatment of Febrile seizures consists of controlling the convulsions with anticonvulsants in dosages analogous to those recommended for the treatment of status epilepticus, reduction of the body temperature via conductive or evaporative cooling of the patient and treatment of the acute infection responsibleThis high recurrence rate of 30–50% and family anxiety rationalize the prophylaxis to prevent further episodes. Many times these complex febrile seizures evolve to

Epilepsy with cognitive and behavioural [problems later in childhood as per the present evidence of literature.

In India, the incidence of FS differs due to reports of different community based studies. The incidence of FS is reported 0.5–10.1% from a single study from South India, 17.7/1000 population from a survey in Bombay and a prevalence rate of 330/10,000 population in a population based neuroepidemiological survey in Bangalore

Complex febrile seizures are defined as as those with focal onset, prolonged duration (greater than 10–15 min), or those that occur more than once within the same febrile illness [10, 11]. Approximately 20 % of FS cases are classified as CFS.Their is growing body of evidence that continuos prophylaxis needs to be given in children with Complex febrile seizures.

Intermittent/ Continuous Valproate, with or without intermittent clobazam is one of the regimes used with varying success. There are no studies available to showthe efficacy of adding/not adding clobazam intermittently in a child with complex febrile seizures already on continuous prophylaxis with various antisezure medications of which valproate is preferred by most physicians and Pediatric Neurologists.

Despite being on Continous prophylaxis many physcians advice intermittent prophylaxis over and above the continuous prophylaxis which needs to be studied and refuted or recommended based on the evidence.

Hence we feel that this needs to be studied in a systematic manner as an RCT.