Review of Over 400 Intravenous Levetiracetam Administrations in Pediatric Patients Ages Newborn Through 11 Years of Age
Abstract number :
PH.07;
Submission category :
7. Antiepileptic Drugs
Year :
2007
Submission ID :
8201
Source :
www.aesnet.org
Presentation date :
11/30/2007 12:00:00 AM
Published date :
Nov 29, 2007, 06:00 AM
Authors :
M. Gustafson1, 2, F. J. Ritter2, 1, M. D. Frost2, 1, J. Doescher2, 1
Rationale: Levetiracetam (LEV) is a widely prescribed antiepileptic drug in adult and pediatric patients. The availability of the intravenous (IV) formulation, approved in adults, provides a continuum of care when oral is not an option. Little information is available on IV LEV in pediatric patients. We investigated the usage, administration technique and tolerability of IV LEV in pediatric patients under 12 years old.Methods: With IRB approval, a list of children who initiated IV LEV between August 2006 and April 8, 2007 at Children's Hospitals and Clinics - St. Paul was generated through computer inquiry. A chart review was performed on all children meeting age criteria. Data collected included demographics, dosing, administration procedures, reason for use and discontinuation and adverse effects (AE).Results: 48 pediatric patients (25 males, 23 females) under 12 years of age (range: 1day-11 yrs,10 mo; median: 22 months) including 7 newborns received a combined total of 401 doses of IV LEV. Two patients received 32.1% of the doses (66 and 63 doses respectively). Single doses ranged from 3.24-51.47 mg/kg/dose (median: 11.9). IV LEV was diluted with either NS or D5W, prepared as a piggyback or in a syringe and administered via pump. The mean IV LEV concentration was 27.8 mg/ml (median: 30 mg/ml; range: 3.66-34 mg/ml). 59.4% of doses were administered via peripheral line (vs. central line) and 94.9% of 399 doses were infused over 15 minutes (range: 10-60 min). For two doses, line type and infusion time were unknown. There were no infusion related AEs except one isolated mild phlebitis rating in the patient receiving 63 total doses. Ten patients had 11 AEs reported and deemed by the treating physician as possibly due to IV LEV: one each for confusion, ataxia, fussiness, chorea and 7 sleepiness/fatigue. 3/10 discontinued IV LEV due to AEs, 6/10 continued IV LEV or transitioned to oral LEV and 1 patient returned to the home AED regimen. Routine vital signs were not required with IV LEV infusions at this institution and therefore were not assessed. Four patients died during IV LEV treatment. No death was deemed by the treating physician as secondary to drug treatment. 25% (12/48) received IV LEV as a continuation of their home oral LEV use for use while unable to take oral. 75% initiated LEV treatment as IV LEV for new onset seizures (29/36) and in patients with known seizures disorders, as an attempt to change from the home AED regimen (5/36) or in place of home oral AED regimens while unable to take oral (2/36). 36/44 (81.8%) patients discharged from the hospital on oral LEV maintenance treatment. 3 discontinued due to side effects, 3 changed back to the original home regimen and 2 discontinued due to lack of acceptable seizure control.Conclusions: Our investigation shows that an average 30 mg/ml IV LEV concentration infused over 15 minutes in patients ages newborn through 11 years of age is easy to administer and well tolerated in both patients exposed to oral LEV or in patients initiating LEV for the first time. (Sources for funding include a grant from UCB Pharma)
Antiepileptic Drugs