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