Skip to main content
. 2018 Jan 10;2018(1):CD001905. doi: 10.1002/14651858.CD001905.pub3

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