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 |
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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 |