Mehta 2007.
Methods | An open‐label, randomised controlled trial | |
Participants | Children, 5 months to 12 years of age, with refractory convulsive status epilepticus. Mean age in Valproate group‐36.3 months and Diazepam group‐44.5 months | |
Interventions | Valproate: LoadIng dose: 30 mg/kg diluted 1:1 in normal saline from 2 to 5 mins followed by infusion @ 5 mg/kg/hour continued until seizure‐free period of 6 hours was reached and then reduced @ 1 mg/kg/hour every 2 hours. Maintenance dose: 10 mg/kg IV every 8 hours Diazepam: 10 microgram/kg/min increased every 5 min by 10 mircogram/kg/min |
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Outcomes | Control of RSE, time interval for control, dose required to control RSE, breakthrough seizures, respiratory depression, hypotension | |
Notes | Study conducted in India | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation method |
Allocation concealment (selection bias) | High risk | No concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Even though not blinded, outcomes such as seizure activity determination and occurrence of adverse events are unlikely to be subject to bias in detection |