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.