Mahmoudian 2004.
Methods | Prospective randomised study in 1 centre | |
Participants | 70 children of both sexes and aged 2 months to 15 years presenting with an acute seizure to the emergency department. Children who had received anticonvulsants before admission were excluded | |
Interventions | intranasal midazolam versus intravenous diazepam | |
Outcomes | Time from drug treatment to seizure cessation (Treatment successful if seizures stopped within 10 minutes) | |
Notes | Both treatment arms showed a 100% seizure cessation rate, which is higher than expected | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was performed in advance with an odd and even number table" Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote: "treatment allocations were sealed in opaque envelopes" Comment: probably done |
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, but 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) | High risk | Time taken to insert intravenous cannula in the intravenous diazepam group should have been included, as this would have a significant effect on the time from arrival to seizure cessation. Other studies comparing intravenous with other routes have included this information |
Other bias | Unclear risk | Both treatment arms showed a 100% seizure cessation rate, which is higher than expected. Unclear whether this high success rate was due to a particular element of the trial design |