Original Articles

Comparing the Efficacy and Safety of Levetiracetam Versus Phenobarbital as the First-Line Drug in the Control of Neonatal Seizures

Abstract

Phenobarbital has long been recognized as a first-line treatment for neonatal seizures. However, due to its side effects and variable effectiveness, levetiracetam has emerged as a potential alternative in some studies, though consensus on this issue remains elusive. This clinical trial aims to compare the efficacy and safety of levetiracetam as a first-line agent for managing neonatal seizures. The study involved 40 neonates, aged 36 to 44 weeks gestational age, who were admitted to the neonatal intensive care unit for clinical seizures and met the inclusion criteria. Participants were randomly assigned to receive either phenobarbital (20 mg/kg intravenously over 15 minutes) or levetiracetam (50 mg/kg intravenously over 15 minutes). If seizures persisted or recurred a second dose was given. If seizures continued after the second dose, a second anticonvulsant was added to the treatment regimen. Cessation of seizures for 24 hours duration after drug administration is considered as primary outcome measure. The two groups were compared based on seizure termination, number of doses administered, need for additional medications, and side effects. Baseline characteristics were similar between the two groups. After the first dose, seizure termination rates were 95% for the levetiracetam group and 85% for the phenobarbital group (P=0.333). Side effects were reported in 20% of neonates receiving phenobarbital (including two cases of bradycardia and irritability) compared to 5% in the levetiracetam group (one case of irritability) (P=0.196). There were no statistically significant differences regarding changes in the treatment regimen or the number of anticonvulsant drugs used. In conclusion, the results of this study indicate that levetiracetam is equally effective as phenobarbital in controlling neonatal seizures and may present a preferable option due to its reduced side effect profile.

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IssueVol 64 No 8 (2026) QRcode
SectionOriginal Articles
Keywords
Neonatal seizures Phenobarbital Levetiracetam First-line drug
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How to Cite
1.
Faraji N, Sabzehei M kazem, Eghbalian F, Shokouhi M, Borghi H. Comparing the Efficacy and Safety of Levetiracetam Versus Phenobarbital as the First-Line Drug in the Control of Neonatal Seizures. Acta Med Iran. 2026;64(8):515-520.