North 1983.
Methods | Random allocation, double‐blind design | |
Participants | Participants with a supratentorial tumor, allocated to 1. Phenytoin: Meningioma (n=10), metastasis (n=6), sellar tumor (n=10), glioma (n=16) 2. Placebo group: meningioma (n=9), metastasis (n=7), sellar tumor (n=7), glioma (n=16) |
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Interventions | Phenytoin 250 mg twice daily iv, then 100 mg orally three times daily x 12 months. Serum levels once a month for inpatients, bimonthly for outpatients. Doses were adjusted accordingly | |
Outcomes | 18 seizures in group treated with phenytoin, 26 in placebo group. By time‐to‐event analysis, group treated with PHT had significantly fewer seizures between days 7‐72 of study. The maximal protective effect was in postop week 2 | |
Notes | Because 65% of seizures occurred within 3 mo from surgery, authors recommended prophylaxis for 2‐3 mo, starting 1 wk before surgery. Focal seizures in 7/9 pts with therapeutic levels | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | D ‐ Not used |