Methods |
Randomisation by sealed envelopes
No blinding |
Participants |
Patients aged over 15 years |
Interventions |
Arm 1 = diazepam 2 ‐ 20 mg IV + phenytoin 6 ‐ 18 mg/kg IV based on initial drug levels
Arm 2 = phenobarbitone 10 ‐ 30 mg/kg IV |
Outcomes |
Cessation of seizures
Requirement for ventilatory support
Mortality
Complications
Adverse effects |
Notes |
Study from California |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
The method of sequence generation not given |
Allocation concealment (selection bias) |
Unclear risk |
Sealed envelopes have been used but it is not clearly mentioned whether they were opaque and serially numbered |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
There was no blinding |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Even though there was no blinding, the outcome measures are unlikely to be susceptible to high degree of bias |