Lee 1989.
Methods | Randomised, double‐blind, placebo‐controlled trial 2 treatment arms: PHT and placebo Patients randomised using random digits, all participants received identical medication Treatment period: 3 days. No follow‐up of participants |
|
Participants | Adults, mean age 39.9 years (PHT) and 37.5 years (placebo) all undergoing intracranial, supratentorial surgery. Participants had no history of seizures and not taking AEDs prior to surgery. 400 participants randomised: 189 to PHT and 185 to placebo. 26 died prior to treatment |
|
Interventions | Group 1: PHT 15 mg/kg for 15‐20 min prior to wound closure followed by 5‐6 mg/kg/day, 3 times daily in first 3 postoperative days Group 2: saline solution administered as described above |
|
Outcomes | Primary outcome: efficacy (number of seizures at 3 days) | |
Notes | 26 participants randomised died prior to treatment, excluded from all data exploration and analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Used random digits, unclear how generated, whether open list, etc |
Allocation concealment (selection bias) | Unclear risk | No details in text |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical medication used for both groups. Adequate blinding methods for key personnel and participants |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear details on study attrition rate and how data analysed |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Other bias | Low risk | No other bias detected |