Evaluation of the safety and tolerability of intravenous undiluted levetiracetam at a pediatric institution

Abstract

AbstractStudy ObjectiveRecent studies suggest rapid administration of high‐dose, undiluted levetiracetam is safe in adults; however, no information exists in pediatric patients. The purpose of this study was to evaluate the safety and tolerability of undiluted levetiracetam at a pediatric institution.DesignRetrospective, single‐center, cohort study.SettingPediatric Academic Medical Center.PatientsAll patients who received high‐dose >60 mg/kg (‒10%) up to 4500 mg undiluted or diluted intravenous levetiracetam were included.InterventionRapid intravenous administration of undiluted versus diluted levetiracetam.Measurements and Main ResultsA total of 776 levetiracetam doses were included, 358 doses administered and 418 doses wasted. The doses administered (61 undiluted and 297 diluted) accounted for a total of 252 patients (39 received undiluted, and 213 received diluted levetiracetam) (median [minimum–maximum range] age, 2 years [1 day to 32.7 years]; mean (standard deviation [SD]) weight, 20.1 kg [22.1 kg]). The incidence of hemodynamic disturbances and infusion‐related reactions was not statistically significant between undiluted (24.6%) and diluted (26.3%) groups (p = 0.87). The median (interquartile range [IQR]) time difference between first‐line antiseizure medication and levetiracetam administration in patients with status epilepticus was 18 min (10.5–30.5) in the undiluted group versus 36.5 min (21.8–67.3) in the diluted group (p < 0.01). Additionally, there was a significant amount of drug waste from dispensed but not administered doses of the diluted bag compared to undiluted vials (57.6% diluted vs. 18.7% undiluted, p < 0.001).ConclusionUndiluted levetiracetam was not associated with an increased incidence of adverse effects compared to diluted levetiracetam in high‐doses, up to 4500 mg given over 5 min in pediatric patients.