Evaluation of the safety and tolerability of intravenous undiluted levetiracetam at a pediatric institution.
child
drug-related side effects and adverse reactions
levetiracetam
status epilepticus
Journal
Pharmacotherapy
ISSN: 1875-9114
Titre abrégé: Pharmacotherapy
Pays: United States
ID NLM: 8111305
Informations de publication
Date de publication:
04 Dec 2023
04 Dec 2023
Historique:
revised:
13
10
2023
received:
13
07
2023
accepted:
21
10
2023
medline:
5
12
2023
pubmed:
5
12
2023
entrez:
5
12
2023
Statut:
aheadofprint
Résumé
Failure of initial benzodiazepine therapy in patients with status epilepticus warrants urgent administration of a second-line antiseizure medication. 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. Retrospective, single-center, cohort analysis of patients who received high-dose >60 mg/kg (-10%) up to 4500 mg diluted or undiluted intravenous levetiracetam between May 6, 2020 to July 31, 2022 at a large pediatric academic medical center. The primary outcome was the assessment of hemodynamic disturbances (bradycardia, hypotension) and/or infusion-related reactions after administration of the levetiracetam infusion. 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 y [1 d-32.7 y]; 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 diluted and undiluted 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 minutes (10.5-30.5) in the undiluted group versus 36.5 minutes (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 versus 18.7% undiluted, p<0.001). 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 minutes in pediatric patients.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
Failure of initial benzodiazepine therapy in patients with status epilepticus warrants urgent administration of a second-line antiseizure medication. 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.
METHODS
METHODS
Retrospective, single-center, cohort analysis of patients who received high-dose >60 mg/kg (-10%) up to 4500 mg diluted or undiluted intravenous levetiracetam between May 6, 2020 to July 31, 2022 at a large pediatric academic medical center. The primary outcome was the assessment of hemodynamic disturbances (bradycardia, hypotension) and/or infusion-related reactions after administration of the levetiracetam infusion.
RESULTS
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 y [1 d-32.7 y]; 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 diluted and undiluted 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 minutes (10.5-30.5) in the undiluted group versus 36.5 minutes (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 versus 18.7% undiluted, p<0.001).
CONCLUSION
CONCLUSIONS
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 minutes in pediatric patients.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023 Pharmacotherapy Publications, Inc.