Sreenath 2010.
Methods | Randomised parallel group design | |
Participants | Children (mean age seven years), male 57%, university hospital setting | |
Interventions | Arm 1: IV Diazepam 0.2 mg/kg (repeated once, if seizure uncontrolled) and IV Phenytoin 18 mg/kg after 15‐30 min Arm 2: IV Lorazepam 0.1 mg/kg (repeated once, if seizure uncontrolled) |
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Outcomes | Cessation of seizures Requirement of different drug/GA Requirement of ventilatory support Long‐term disabling sequelae Deaths Adverse effects Follow‐up only in hospital, period: 18 hours |
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Notes | Study carried out in India, single centre. Funding source not mentioned | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used computer‐generated random numbers |
Allocation concealment (selection bias) | Unclear risk | Used sealed envelopes but no mention of whether they were opaque and serially numbered |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of blinding may have affected institution of co‐intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Even though not blinded, outcomes such as seizure activity determination is unlikely to be subject to bias in detection |