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. 2018 May 23;2018(5):CD007286. doi: 10.1002/14651858.CD007286.pub4

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