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

Chamberlain 1997.

Methods Prospective randomised study in two centres
Participants 23 children of both sexes and aged birth to 18 years presenting to an emergency department with a motor seizure lasting at least 10 minutes
 Children who had established intravenous access or who had already received treatment for this seizure episode were excluded.
Interventions Intramuscular midazolam versus intravenous diazepam
Outcomes Seizure cessation within 5 minutes of drug administration
 Delayed seizure control defined as cessation of seizures 5 ‐ 10 minutes after drug administration
 Treatment failure, defined as lack of seizure cessation at 10 minutes
 Early recurrence, defined as return of seizures within 5 minutes
 Recurrence, defined as return of seizures within 60 minutes of drug administration
 Presence of respiratory depression
Notes 1 child was enrolled in the study twice, so is represented in both groups. It was not possible to identify this child in the reported results
There was also a protocol violator who was randomised to receive intravenous diazepam but received intramuscular midazolam after 25 minutes, due to unsuccessful intravenous access. This participant was excluded from the analysis and would have skewed the results significantly if he/she had been included. It may have been helpful to know the response time of this child once treatment was administered, as this is an important example of the disadvantages of the intravenous route
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomly selected by computer"
Comment: probably done
Allocation concealment (selection bias) Unclear risk Insufficient information to assess this
Blinding (performance bias and detection bias) 
 All outcomes Low risk 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 Unclear risk Quote "Three children were randomised to receive diazepam but were excluded because their seizures did not persist for 10 minutes."
Comment: this is unlikely to have made a significant difference to the analysis
Quote "One child was a protocol deviation and was excluded‐ was randomised to diazepam but received midazolam instead due to unsuccessful attempts at IV access"
Comment: this child should have been included in the analysis for it to be considered an intention‐to‐treat analysis. However it would have skewed the results significantly, as midazolam was not given until after 25 minutes of attempting intravenous access
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported in the Results section
Other bias High risk 1 child was enrolled in the study twice, so is represented in both groups. It was not possible to identify this child in the reported results. Due to the small numbers of children included in the study, this double‐enrolment may have impacted on the results