?Levetiracetam vs Phenytoin for Status Epilepticus and Cluster Seizures - A prospective, randomized study?

Status Epilepticus (SE) is a fairly common medical emergency with high morbidity and mortality. Few effective parenteral medications are currently available for the management of SE. Inj benzodiazepine followed by IV phenytoin are usually used as first line treatment for SE. However, sedation, hemodynamic complications, failure to control seizures/status in some patients, etc. are recognized drawbacks of current management regimes. Levetiracetam is a novel anticonvulsant with a novel mechanisms of action - of neuronal binding to synaptic vesicle protein 2A and thus inhibiting neurotransmitter release. In a recent review, 498 patients with SE treated with this agent experienced successful control in about 70% of cases. However, these were studies with varied designs, including retrospective reviews, but not including prospective randomized, studies. This study aims to examine the efficacy of IV levetiracetam in controlling SE and cluster seizures (CS), in comparison with IV phenytoin, using a prospective, randomized study design. Adult patients with SE or CS, following an initial dose of IV benzodiazepine ( lorazepam 2-4 mg for aborting the seizures), will be randomized to receive either inj.phenytoin (18 mg / kg) or inj.levetiracetam (30mg/kg) intravenously as a bolus, with close hemodynamic and neurologic monitoring. Maintenance treatment with same anticonvulsant agents will be continued. Demographics, neurologic deficits, conscious state, imaging findings, biochemical profiles will be documented. Efficacy of these agents in control of seizures over next 2 and 24 hours, adverse effects, need for ICU admission and discharge outcome will be compared between the two cohorts, using univariate analysis methods.