Momen Ali Akbar, Azizi Malamiri Reza, Nikkhah Ali, Jafari Maryam, Fayezi Abbas, Riahi Kourosh, Maraghi Elham
Department of Paediatric Neurology, Golestan Medical, Educational, and Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Department of Paediatric Neurology, Golestan Medical, Educational, and Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Eur J Paediatr Neurol. 2015 Mar;19(2):149-54. doi: 10.1016/j.ejpn.2014.11.007. Epub 2014 Nov 29.
The aim of this study was to evaluate the efficacy and safety of intramuscular midazolam in controlling convulsive status epilepticus in children, by comparing it with rectal diazepam.
In this randomized trial, 100 children (50 in each group) with convulsive status epilepticus aged 1 month to 16 years were enrolled and randomly assigned into two groups to receive either 0.3 mg/kg intramuscular midazolam or 0.5 mg/kg rectal diazepam. Main outcome measure was stopping of all motor activity after drug administration. Another measures were times between patient's arrival to emergency department till drug administration, between drug administration to seizure cessation, and between patient's arrival to seizure cessation.
Both medication were effective for seizure control and no significant difference was found between successful treatments after administering the medication (P = 0.061). In the midazolam group, in 96% (48/50) of cases treatment was successful and in the diazepam group, in 94% (47/50) of cases treatment was successful. Time from arrival to administering the medication was significantly shorter in midazolam group (P = 0.017). The majority of seizures in midazolam group were stopped in less than 66 s (median) compared to 130 s (median) for diazepam group, (P < 0.001). No serious adverse effects were seen in both groups.
IM midazolam is not superior but may be at least as effective as rectal diazepam for controlling of status epilepticus in children. Midazolam via IM route could be one of the choices in children with convulsive status seizures who have difficult IV access.
本研究旨在通过将肌内注射咪达唑仑与直肠给予地西泮进行比较，评估肌内注射咪达唑仑控制儿童惊厥性癫痫持续状态的疗效和安全性。
在这项随机试验中，纳入了100名年龄在1个月至16岁的惊厥性癫痫持续状态儿童（每组50名），并随机分为两组，分别接受0.3mg/kg肌内注射咪达唑仑或0.5mg/kg直肠给予地西泮。主要结局指标是给药后所有运动活动停止。其他指标包括患者到达急诊科至给药的时间、给药至癫痫停止的时间以及患者到达至癫痫停止的时间。
两种药物对癫痫控制均有效，给药后成功治疗之间未发现显著差异（P = 0.061）。在咪达唑仑组中，96%（48/50）的病例治疗成功，在地西泮组中，94%（47/50）的病例治疗成功。咪达唑仑组从到达至给药的时间明显更短（P = 0.017）。咪达唑仑组大多数癫痫发作在不到66秒（中位数）内停止，而地西泮组为130秒（中位数），（P < 0.001）。两组均未观察到严重不良反应。
肌内注射咪达唑仑并不优于直肠给予地西泮，但在控制儿童癫痫持续状态方面可能至少同样有效。对于静脉穿刺困难的惊厥性癫痫发作儿童，肌内注射途径的咪达唑仑可能是选择之一。
