Tonekaboni Seyed-Hassan, Shamsabadi Farhad Mahvelati, Anvari Seyed-Saeed, Mazrooei Ali, Ghofrani Mohammad
Department of Pediatrics, Shahid Beheshti University of Medical Sciences, Tehran, Iran ; Pediatric Neurology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Iran J Pediatr. 2012 Sep;22(3):303-8.
The purpose of the present study is to compare efficacy and safety of buccal midazolam with intravenous diazepam in control of seizures in Iranian children.
This is a randomized clinical trial. 92 patients with acute seizures, ranging from 6 months to 14 years were randomly assigned to receive either buccal midazolam (32 cases) or intravenous diazepam (60 cases) at the emergency department of a children's hospital. The primary outcome of this study was cessation of visible seizure activity within 5 minutes from administration of the first dosage. The second dosage was used in case the seizure remained uncontrolled 5 minutes after the first one.
In the midazolam group, 22 (68.8%) patients were relieved from seizures in 10 minutes. Meanwhile, diazepam controlled the episodes of 42 (70%) patients within 10 minutes. The difference was, however, not statistically significant (P=0.9). The mean time required to control the convulsive episodes after administration of medications was not statistically significant (P=0.09). No significant side effects were observed in either group. Nevertheless, the risk of respiratory failure in intravenous diazepam is greater than in buccal midazolam.
Buccal midazolam is as effective as and safer than intravenous diazepam in control of seizures.
本研究旨在比较颊部给予咪达唑仑与静脉注射地西泮对伊朗儿童癫痫发作的控制效果及安全性。
这是一项随机临床试验。92例年龄在6个月至14岁的急性癫痫发作患儿被随机分配至儿童医院急诊科,分别接受颊部给予咪达唑仑(32例)或静脉注射地西泮(60例)治疗。本研究的主要结局是首次给药后5分钟内可见癫痫活动停止。若首次给药5分钟后癫痫仍未得到控制,则使用第二次剂量。
在咪达唑仑组中,22例(68.8%)患者在10分钟内癫痫发作得到缓解。同时,地西泮在10分钟内控制了42例(70%)患者的发作。然而,差异无统计学意义(P = 0.9)。给药后控制惊厥发作所需的平均时间差异也无统计学意义(P = 0.09)。两组均未观察到明显的副作用。尽管如此,静脉注射地西泮导致呼吸衰竭的风险高于颊部给予咪达唑仑。
颊部给予咪达唑仑在控制癫痫发作方面与静脉注射地西泮同样有效且更安全。