Levetiracetam versus Phenobarbitone in Neonatal Seizures –A Randomized Controlled Trial

ABSTRACT

Objective: To compare the efficacy and safety of intravenous Levetiracetam andPhenobarbitone in the treatment of neonatal seizures. Design: Open labelled, Randomizedcontrolled trial. Setting: Level III Neonatal Intensive Care Unit (NICU). Participants: 100neonates (0-28 days) with clinical seizures. Intervention If seizures persisted even aftercorrection of hypoglycemia and hypocalcemia, participants were randomized to receive eitherLevetiracetam (20 mg/kg) or Phenobarbitone (20 mg/kg) intravenously. The dose of samedrug was repeated if seizures persisted (20 mg/kg of Levetiracetam or 10 mg/kg ofPhenobarbitone) and changeover to other drug occurred if the seizures persisted even aftersecond dose of same drug. Main outcome measures: Cessation of seizures with one or twodoses of the first drug, and remaining seizure-free for the next 24 hours. Results: Seizuresstoped 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 thephenobarbitone group (hypotension in 5, bradycardia in 3 and requirement of mechanicalventilation in 2 neonates) while none had any adverse reaction in Levetiracatam group.Conclusion: Levetiracetam achieves better control than Phenobarbitone for neonatalseizures when used as first-line antiepileptic drug, and is not associated with adverse drugreactions.