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

Abstract Study Objective Recent 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. Design Retrospective, single‐center, cohort study. Setting Pediatric Academic Medical Center. Patients All patients who received high‐dose >60 mg/kg (‒10%) up to 4500 mg undiluted or diluted intravenous levetiracetam were included. Intervention Rapid intravenous administration of undiluted versus diluted levetiracetam. Measurements and Main Results A 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). Conclusion Undiluted 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.