| Methods |
Randomised parallel group design |
| Participants |
Adult patients with out‐of‐hospital status epilepticus treated by paramedics. Mean age: 50 yrs, male 63%. Setting: pre hospital treatment by paramedics of Dept of public health, San Francisco, USA |
| Interventions |
Experimental = diazepam (5 mg) or lorazepam (2 mg), IV, pre hospital
Control = matching placebo |
| Outcomes |
Cessation of status on arrival to hospital
Requirement for ventilatory support on arrival to hospital
Status of recovery (neurological outcome) at discharge from hospital
Mortality in hospital
Complications during transfer
Adverse effects of drugs |
| Notes |
Study conducted in USA. Funded by NIH, single‐centre study |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation by computer‐generated sequence of random numbers |
| Allocation concealment (selection bias) |
Low risk |
Coded kits with identical content were used |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double blind, placebo‐controlled trial |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Double blind, placebo‐controlled trial |
