Talukdar 2009.
Methods | Prospective randomised trial in a single centre | |
Participants | 120 children of both sexes aged 0 ‐ 12 years (mean age 3.2 years) presenting with an episode of convulsion, irrespective of cause and duration. Those patients with myoclonic, absence and atonic seizures were excluded | |
Interventions | Buccal midazolam versus intravenous diazepam | |
Outcomes | Cessation of all motor activity within or by 5 minutes of administration of the drug Treatment initiation time (time from noting seizure to drug administration), drug effect time (time from drug administration to effect) and total controlling time, a combination of the previous two | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomisation was done using the random number table" Comment: probably done |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to assess this |
Blinding (performance bias and detection bias) All outcomes | Low risk | Study unblinded, but blinding would not have been possible due to the different routes of administration of the 2 study drugs; this is not likely to have affected outcome |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were included in the analysis |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported in the Results section |
Other bias | Low risk | None identified |
IV: intravenous PICU: paediatric intensive care unit RCT: randomised controlled trial