Buccal midazolam vs rectal diazepam administered by parents for continuing and serial epileptic seizures: a randomised controlled trial of parental preferences

Aim: We aimed to undertake a small study comparing buccal midazolam and rectal diazepam in the emergency out-of-hospital treatment of prolonged or serial epileptic seizures in children. We wanted to see if the parent/carer could not only administer the emergency medication but also document the timings and outcomes of the trial. We also aimed to demonstrate parental preference for either treatment. Methods: This was an open-label, randomised, cross-over clinical trial. The primary outcome was parental preference, secondary outcomes included therapeutic success (seizure stopped within 10 minutes of treatment with no relapse in the next 24 hours), and adverse events. Research Ethics Committee approval and appropriate written informed consent were obtained for all participants. Identical convenient age-related doses of buccal midazolam and rectal diazepam were used: for those aged 6 to < 12 months, 2.5 mg was prescribed; for those aged 1 to < 5 years, 5 mg; 5 to < 10 years, 7.5 mg; 10 years and over, 10 mg. Appropriate randomisation and statistical methods were used. Results: Twelve children, three males, aged 2.5–8 (median 5) years, including 10/12 with developmental delay or intellectual impairment completed the trial. Each participant had between 2–4 types of epileptic seizure, was taking 2–3 different regular antiseizure medications, and had been previously on 2–9 (median 3) regular other antiseizure medications in the past. Nine of twelve parents preferred buccal midazolam, 1/12 preferred rectal diazepam (P < 0.05). Therapeutic success was seen in 7/12 participants with either treatment. No respiratory depression was seen in this small trial. Conclusions: Buccal midazolam was clearly preferred to rectal diazepam by parents. This small study was not powered to show a difference in efficacy and adverse effects. The study did show that the cross-over design with parents recording trial data, including data for the outcome measures was feasible.