Oromucosal midazolam in patients with prolonged acute convulsive seizures: An Italian experience

Abstract

Objective: In pediatric age, convulsive seizures lasting more than 5 minutes represent a life- threatening condition. Oromucosal midazolam is a promising first-line treatment option, which is approved in the EU for the treatment of prolonged, acute, convulsive seizures (PACS), in patients aged between 6 months and 18 years. The aim of this study is to evaluate the effectiveness of oromucosal midazolam and, to compare with rectal diazepam efficacy. Methods: We included all consecutive patients followed-up at Bambino Gesù Children's Hospital in Rome who received oromucosal midazolam treatment between January 2015 and July 2016. A telephone survey was carried out to evaluate effectiveness, tolerability and convenience of the administration route of oromucosal midazolam in terminating PACS. Moreover, when rectal diazepam was previously used, has been asked a comparative effectiveness between the two benzodiazepines. Results: We enrolled 293 patients (149 males), aged between 6 months and 18 years (9±4,61 years old; median: 9 years) at the time of prescription, with a 16-month follow-up in average (16±5,24 months). Most of them (98/203, 48%) had a symptomatic epilepsy and 90% (268/273) received oromucosal midazolam care plan for the first time. We will present the results of the telephone survey. Conclusion: In the previous reported clinical trials, oromucosal midazolam was at least as effective as rectal diazepam in the treatment of PACS in children and was generally well tolerated. The results of this survey showed that oromucosal midazolam has several advantages if compared with rectal diazepam, the previous gold standard of treatment, such as having a more convenient and socially acceptable administration route.