(866) Safety and Tolerability of Intravenous Undiluted Levetiracetam in Pediatrics

Introduction: Multiple studies have demonstrated the safety and tolerability of intravenous (IV) undiluted levetiracetam (LEV) 100 mg/mL in adults, however, there is an absence of published data in pediatrics. IV undiluted LEV administration eliminates dilution errors during medication preparation and can minimize operational delays. The purpose of this study is to evaluate the safety and tolerability of IV undiluted LEV in pediatrics.

Methods: This was a retrospective study evaluating concentration-related adverse drug events (ADE) with IV LEV 100 mg/mL (undiluted) or 15 mg/mL (diluted) in pediatric patients (age < 14 years old) from Oct. 1, 2019 to Dec. 31, 2022. Data collection included: number of administrations, IV site, gauge, dose, indication, and age. To identify IV LEV related ADE, the hospital's adverse event reporting system was searched along with the patient chart search function using key search terms: burn, pain, erythema, agitation, extravasation, IV line replacement, Keppra, LEV, adverse reaction, adverse event.

Results: 60 undiluted administrations in 52 pediatric patients and 115 diluted administrations in 42 pediatric patients were given. 8 patients received both undiluted and diluted LEV in the same IV line during their hospitalization. Top percent of administrations reported: Undiluted–anatomic IV site: antecubital 66.6%, hand 23.3%, forearm 6.7%, foot 1.7%, ankle 1.7%; IV gauge: 22G 63.3%, 20G 20%, 24G 16.7%; central line 0%; dose range 50 – 2000 mg; loading doses 80%; age range: 3 weeks – 13 yo. Diluted–anatomic IV site: antecubital 44.3%, hand 26.1%; IV gauge: 22G 44.3%, 24G 44.3%, 20G 9.1%, 18G 2.3%; central line 23.5%; dose range 32.6 – 1500 mg; maintenance doses 64.3%, loading doses 28.7%; age range: 5 days – 12 yo. Of note, 58.3% in undiluted group and 81.7% in diluted group were < 5 years old. There were no IV LEV extravasation events nor ADE reported in the adverse event reporting system. No concentration-related adverse events or infusion site reactions were identified after key term chart review for either undiluted or diluted LEV.

Conclusions: Regardless of IV site, gauge, dose, and age, there were no documented safety differences between undiluted and diluted LEV. IV undiluted levetiracetam is safe and tolerable in pediatrics with no concentration-related adverse effects.