Singhi 2002.
Methods | Randomised parallel group design | |
Participants | Children (mean 3.75 years), male 78%, university hospital intensive care setting | |
Interventions | Arm 1 = midazolam 0.2 mg/kg bolus followed by 2‐10 microgram/kg/min infusion
Arm 2 = diazepam 0.01 ‐ 0.1 mg/kg/min infusion Route of administration: IV |
|
Outcomes | Cessation of seizures
Recovery at discharge and during follow‐up
Mortality
Complications
Adverse effects Out‐patient follow‐up period: not specified |
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Notes | Study from India, single centre, no mention of any funding source | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation in blocks of six by sealed envelopes |
Allocation concealment (selection bias) | Low risk | The random assignment was kept sealed in an envelope by a faculty member not directly involved in the study |
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 are unlikely to be subject to bias in detection |