Levetiracetam versus Phenobarbitone in Neonatal Seizures - A Randomized Controlled Trial.

OBJECTIVE:To compare the efficacy and safety of intravenous Levetiracetam and Phenobarbitone in the treatment of neonatal seizures. DESIGN:Open labelled, Randomized controlled trial. SETTING:Level III Neonatal Intensive Care Unit (NICU). PARTICIPANTS:100 neonates (0-28 days) with clinical seizures. INTERVENTION:If seizures persisted even after correction of hypoglycemia and hypocalcemia, participants were randomized to receive either Levetiracetam (20 mg/kg) or Phenobarbitone (20 mg/kg) intravenously. The dose of same drug was repeated if seizures persisted (20 mg/kg of Levetiracetam or 10 mg/kg of Phenobarbitone) and changeover to other drug occurred if the seizures persisted even after second dose of same drug. MAIN OUTCOME MEASURES:Cessation of seizures with one or two doses of the first drug, and remaining seizure-free for the next 24 hours. RESULTS:Seizures stoped in 43 (86%) and 31 (62%) neonates in Levetiracetam and Phenobarbitone group, respectively (RR 0.37; 95%CI 0.17, 0.80, P<0.01). 10 neonates had adverse reactions in the phenobarbitone group (hypotension in 5, bradycardia in 3 and requirement of mechanical ventilation in 2 neonates) while none had any adverse reaction in Levetiracatam group. CONCLUSIONS:Levetiracetam achieves better control than Phenobarbitone for neonatal seizures when used as first-line antiepileptic drug, and is not associated with adverse drug reactions.