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. |
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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 |