. Diptiman Jayswal; . Uttam Kumar Roy; . Taraknath Ghosh; . Purnendu Mandal
Volume 11, Issue 3 , March 2021, , Pages 1-6
Abstract
BACKGROUND: Neonatal seizure (NS) reflects serious underlying brain injury, requiring immediateevaluation and early treatment. In neonates, phenobarbitone and phenytoin are used primarily ...
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BACKGROUND: Neonatal seizure (NS) reflects serious underlying brain injury, requiring immediateevaluation and early treatment. In neonates, phenobarbitone and phenytoin are used primarily tocontrol the seizures. If uncontrolled, widespread off‑label use of midazolam and levetiracetam waspracticed. These drugs gained popularity though there are no such studies available on literaturesearch comparing them. The present study was designed to explore these lacunae using these twodrugs in refractory cases. To study the efficacy and adverse drug reactions (ADRs) of midazolamand levetiracetam not responding to usual line of therapy.MATERIALS AND METHODS: This was a prospective cross-sectional study conducted on 69neonates in the NICU and Department of Pharmacology in Burdwan Medical College and Hospital,West Bengal. Patients receiving midazolam or levetiracetam when uncontrolled with first lineantiepileptics, namely, phenobarbitone and phenytoin, were considered eligible. The study variableswere time to control seizure, seizure recurrence and frequency, and treatment-related adverse events.analysis used Mann–Whitney U-test were applied Comparison with respect to time to control andChi-square test were applied to detect difference in proportion for ADRs. The SPSS Statistics 17.0was used for analysis.RESULTS: We compared the time periods to control neonatal seizure for effectiveness betweenlevetiracetam and midazolam showing no significant difference (P = 0.190). Comparing the portionof recurrences in two groups gives statistically nonsignificant (P = 0.878) result. Only respiratorydepression was seen in the levetiracetam group (12.90%) and midazolam group (18.42%). Alladverse events were ‘probable’ as per the WHO‑UMC criteria, and there was no statistically significantdifference between the two drugs (P = 0.533).CONCLUSIONS: Both midazolam and levetiracetam are equally effective and safe in NS notresponding to usual line of treatment.