Levetiracetam versus Phenobarbitone in Neonatal Seizures –A Randomized Controlled Trial

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Date
2019-08
Journal Title
Journal ISSN
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Publisher
Indian Academy of Pediatrics
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.
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Keywords
Antiepileptic drugs, Convulsions, Management, Neonate, Outcome
Citation
Gowda Vykuntaraju K, Romana Ayesha, Shivanna Niranjan H, Benakappa Naveen, Benakappa Asha. Levetiracetam versus Phenobarbitone in Neonatal Seizures –A Randomized Controlled Trial. Indian Pediatrics. 2019 Aug; 56(8): 643-646