Franceschetti 1990.
Methods | Randomised, controlled parallel trial, single centre trial. 2 treatment arms, one no treatment arm No details available in text of randomisation or blinding methods employed Treatment period: unclear Follow up: >6months to <12 months |
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Participants | Mean age 55 years, 34 men and 29 women undergoing supratentorial craniotomy for neoplasms 128 patients entered trial Group A: 65 participants had pre‐operative seizures and were treated with AEDs (excluded from this review) Group B: 63 participants had no seizures prior to operation and were not taking any AEDs |
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Interventions | 3 treatment arms for Group B randomised participants: PB, PHT and no treatment Group 1: PB (4 mg/kg daily for 5 days), followed by 2 mg/kg daily Group 2: PHT (10 mg/kg daily for 5 days), followed by 5 mg/kg daily Group 3: no treatment |
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Outcomes | Primary outcomes: efficacy (number of seizures (early and late seizures), adverse effects | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details in text |
Allocation concealment (selection bias) | Unclear risk | No details in text |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details in text |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition unreported, 24 participants with missing data for late seizure outcome |
Selective reporting (reporting bias) | Unclear risk | No trial protocol available |
Other bias | Low risk | No other bias detected |