Incidence of intravenous site reactions in neurotrauma patients receiving valproate or phenytoin.
OBJECTIVE
To determine the incidence of intravenous site reactions to phenytoin and valproate in a large population of patients with neurotrauma.


METHODS
Retrospective chart review of two double-blind, randomized clinical trials evaluating the use of antiepileptic drugs to prevent posttraumatic seizures in patients with neurotrauma: phenytoin versus placebo (n = 390), and valproate versus phenytoin with placebo (n = 385). Information collected from the charts included the number, type, and location of intravenous lines and intravenous site events.


METHODS
Tertiary care trauma and university teaching hospital.


RESULTS
Intravenous site reactions occurred in 18% and 25% of patients receiving valproate or phenytoin, respectively, with the majority of events (70%) occurring in the first intravenous site. Patients received the neurosurgery study drug (NSSD) by either central or peripheral lines; all intravenous site reactions occurred in peripheral administration sites. When patients who received the drug by central line during the course of therapy were excluded, the estimated incidence of site reactions was 21% and 30% for valproate and phenytoin, respectively (p = 0.056). The time to the first event was shorter with phenytoin compared with valproate (2.0 +/- 1.3 vs. 3.0 +/- 1.9 d; p = 0.009). Fewer adverse events were noted with phenytoin in the phenytoin-without-valproate study than in the phenytoin-with-valproate study, with 4.3% and 8.2% of intravenous site events recorded in patients receiving placebo or phenytoin, respectively. There was no significant difference in the number of intravenous lines per patient used during NSSD drug infusion for phenytoin versus placebo or phenytoin versus valproate.


CONCLUSIONS
Both intravenous phenytoin and valproate resulted in intravenous site reactions, with the loading doses responsible for the majority of the events.
Anderson
G D
GD
Department of Pharmacy, University of Washington, Seattle, USA.
Lin
Y
Y
Temkin
N R
NR
Fischer
J H
JH
Winn
H R
HR
D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects*; D001930:Brain Injuries / Q000188:drug therapy / Q000601:surgery; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced*; D010672:Phenytoin / Q000008:administration & dosage / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D014635:Valproic Acid / Q000008:administration & dosage / Q000009:adverse effects*
D000927:Anticonvulsants; D014635:Valproic Acid; D010672:Phenytoin