Methods |
Random allocation, placebo‐controlled design, unblinded |
Participants |
63 of 128 participants had never seized. They had meningioma (n=27), malignant glioma (n=23) or metastases (n=13) |
Interventions |
Group A: 65 pts with preoperative seizures (not considered in this review). Group B: 63 pts without preoperative seizures, randomized in three subgroups: no treatment (n=22); Phenobarbital 4 mg/kg/day x 5 days, then 2mg/kg/day orally (n=25); and phenytoin 10 mg/kg/d x 5 days, then 5 mg/kg/d orally once daily (n=16) |
Outcomes |
Prophylaxis lowered early postop seizures compared with no treatment (7% vs. 18%) without reaching statistical significance. No effect in preventing late postoperative seizures. The authors recommended prevention with phenobarbital for the first postoperative wk 1, but not for later |
Notes |
No trial size calculations. Unspecified adverse events in four participants in the treatment group during the first postoperative week. No mention of adverse effects in the late postoperative period and no mention of withdrawals |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
D ‐ Not used |