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. 2018 Jan 10;2018(1):CD001905. doi: 10.1002/14651858.CD001905.pub3

McIntyre 2005.

Methods Multicentre randomised controlled trial over 3 years 4 months. Randomisation of 2 drugs in weekly blocks
Participants 177 children of both sexes aged 6 months to 16 years presenting to a children's accident and emergency department with active generalised tonic‐clonic seizures including established convulsive status epilepticus.
Children with partial seizures or non‐convulsive status epilepticus were excluded.
Interventions Buccal midazolam versus rectal diazepam
Outcomes Seizure cessation without recurrence within 1 hour and without respiratory depression
Notes 219 convulsive episodes were recorded in the 177 children. Some results are reported only as the number of episodes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: " weekly blocks of treatment were randomly selected for each of the four centres. The randomisation sequence was generated ...from a table of random numbers"
Comment: probably done
Allocation concealment (selection bias) High risk Quote: "Allocation was not concealed from attending staff"
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.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "46 episodes were excluded". 46 episodes were screened for eligibility but did not meet criteria; all participants were included in the analysis
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported in the Results section
Other bias Unclear risk None identified