Status epilepticus constitutes one of the most time-bound medical emergencies in children that should be anticipated well ahead in any children presenting to the hospital with acute seizures . the incidence of status epilepticus varies between 4-38 episodes/100000 children/year(1). Status epilepticus is defined “as a seizure lasting for more than 30minutes or recurrent seizures for more than 30minutes during which the patient doesn’t regain consciousness”. However for operational purposes status epilepticus is defined as convulsive status epilepticus when there is continuous seizure lasting for five minutes or more or two or more discrete seizures between which there is incomplete recovery of consciousness(2).Despite various advances and newer drugs still it constitutes a major cause of neurological sequelae and mortality. For managing a child with CSE guidelines recommends to adopt early use of anticonvulsants drugs.
Treatment for status epilepticus should be initiated as soon as possible because any further delay leads to persistent seizure activity which may not subsides on its own(3). Prolonged duration of status epilepticus leads to refractory status epilepticus which are not only difficult to control but also leads to further complications like hypotension, respiratory and metabolic acidosis hypoglycaemia arrhythmia acute kidney injury(4,5). Neurological complications include neuronal necrosis of brain regions with highest metabolic rate leading to deleterious effects on brain growth and development(6).CSE requires continuous monitoring of vital parameters and establishing adequate airway breathing and circulation and managing the underlying etiology that provoked the initiation of CSE. Both morbidity and mortality in children presenting wit status epilepticus are also related to the duration of seizures and underlying factors that provoked seizures initiation.
The most common etiology of status epilepticus in children are systemic infections which are not localised in central nervous system(3). Acute symptomatic seizures constitute majority of the causes for status epilepticus in children, early intervention by correction of the inciting etiology may further prevent seizure progression. In a study conducted in India in pediatric age group shows 53% of children had status epilepticus as their first presentation (7). Benzodiazepines remain the initial drug of choice for convulsive status epilepticus. After initiation of the emergent therapy, urgent therapy involves initiation of AED like phenytoin, valproate or levetiracetam. There are no definitive or evidence-based guidelines currently available concerning the choice of drugs that to be used beyond first-line anticonvulsant medications.
The currently approved standard anticonvulsants like phenytoin, valproate have various known adverse effects like bone marrow suppression, hepatotoxicity and various other drug interactions which are not seen in levetiracetam, making restriction of its usage in certain conditions. Hence there is a need for a second line anticonvulsant agents which has minimal drug interactions and adverse effects that can be used widely in various etiological conditions causing CSE in children. Levetiracetam, a newer antiepileptic drug currently available has shown better safety profile and beneficial results in various case reports and observational studies. Though there are various randomised studies conducted in adult age group comparing levetiracetam and other parenteral AEDs(8), the results of these adult studies cannot be extrapolated as the etiological conditions, outcomes and neurophysiological properties of a developing brain is different from adult brain, hence there is a need for a studies comparing valproate, phenytoin with the levetiracetam in pediatric populations presenting with CSE.
Requirement for further randomised controlled trials comparing newer antiepileptic drugs in convulsive status epilepticus has been emphasized in various reviews(9,10) We hypothesized that levetiracetam as a second line anticonvulsant which is equally as efficacious in controlling CSE in children. In view of this, we conducted a randomised double-blinded controlled trial comparing the efficacy of phenytoin, valproate and levetiracetam and their clinical outcomes in CSE in children.