Fişgin 2002.
| Methods | Prospective quasi‐randomised study (odd and even days randomisation of the 2 drugs) over 15 months | |
| Participants | 45 children of both sexes and aged 1 month to 13 years presenting to the emergency room with a seizure lasting at least 5 minutes No exclusion criteria stated | |
| Interventions | intranasal midazolam versus rectal diazepam | |
| Outcomes | Stopping of seizure within 10 minutes Time to cessation of seizure Efficacy of anticonvulsant effect Need for a second drug to control seizures Presence of complications | |
| Notes | Some methodology described unclear, particularly relating to seizure type and aetiology of included children. It is therefore unclear if the population of this study is generalisable | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "Diazepam was given on odd days of the month and midazolam on the even days" |
| Allocation concealment (selection bias) | High risk | See above; no concealment of allocation |
| 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) | Unclear risk | Quote: "information about previous convulsions and history of antiepileptic medication was obtained.." Comment: this information was not reported in the Results section but as this is not one of the primary outcome measures it is not likely to be significant |
| Other bias | Unclear risk | Unclear description of the seizure type and aetiology of included children, so it is unclear if the population of this study is generalisable |