Holsti Maija, Dudley Nanette, Schunk Jeff, Adelgais Kathleen, Greenberg Richard, Olsen Cody, Healy Aaron, Firth Sean, Filloux Francis
Department of Pediatrics, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108, USA.
Arch Pediatr Adolesc Med. 2010 Aug;164(8):747-53. doi: 10.1001/archpediatrics.2010.130.
To compare intranasal midazolam, using a Mucosal Atomization Device (IN-MMAD), with rectal diazepam (RD) for the home treatment of seizures in children with epilepsy.
Prospective randomized study.
Patients' homes and a freestanding children's hospital that serves as a referral center for 5 states.
A total of 358 pediatric patients who visited a pediatric neurology clinic from July 2006 through September 2008 and were prescribed a home rescue medication for their next seizure.
Caretakers were randomized to use either 0.2 mg/kg of IN-MMAD (maximum, 10 mg) or 0.3 to 0.5 mg/kg of RD (maximum, 20 mg) at home for their child's next seizure if it lasted more than 5 minutes.
The primary outcome measure was total seizure time after medication administration. Our secondary outcome measures were total seizure time, time to medication administration, respiratory complications, emergency medical service support, emergency department visits, hospitalizations, and caretakers' ease of administration and satisfaction with the medication.
A total of 92 caretakers gave the study medication during a child's seizure (50 IN-MMAD, 42 RD). The median time from medication administration to seizure cessation for IN-MMAD was 1.3 minutes less than for RD (95% confidence interval, 0.0-3.5 minutes; P=.09). The median time to medication administration was 5.0 minutes for each group. No differences in complications were found between treatment groups. Caretakers were more satisfied with IN-MMAD and report that it was easier to give than RD.
There was no detectable difference in efficacy between IN-MMAD and RD as a rescue medication for terminating seizures at home in pediatric patients with epilepsy. Ease of administration and overall satisfaction was higher with IN-MMAD compared with RD. Trial Registration clinicaltrials.gov Identifier: NCT00326612.
比较使用黏膜雾化装置（鼻内咪达唑仑，IN-MMAD）与直肠地西泮（RD）对癫痫患儿在家中发作时的治疗效果。
前瞻性随机研究。
患者家中以及一家独立的儿童医院，该医院是五个州的转诊中心。
2006年7月至2008年9月期间到儿科神经科门诊就诊并被开具下次发作时家庭急救药物的358名儿科患者。
如果患儿下次发作持续超过5分钟，护理人员被随机分配在家中使用0.2mg/kg的IN-MMAD（最大剂量10mg）或0.3至0.5mg/kg的RD（最大剂量20mg）。
主要观察指标是给药后总的发作时间。次要观察指标包括总的发作时间、给药时间、呼吸并发症、紧急医疗服务支持、急诊就诊、住院情况以及护理人员给药的难易程度和对药物的满意度。
共有92名护理人员在患儿发作时给予了研究药物（50名使用IN-MMAD，42名使用RD）。IN-MMAD给药至发作停止的中位时间比RD短1.3分钟（95%置信区间，0.0 - 3.5分钟；P = 0.09）。每组给药的中位时间均为5.0分钟。治疗组之间在并发症方面未发现差异。护理人员对IN-MMAD更满意，且报告称其给药比RD更容易。
对于癫痫患儿在家中发作时作为终止发作的急救药物，IN-MMAD和RD在疗效上没有可检测到的差异。与RD相比，IN-MMAD的给药便利性和总体满意度更高。试验注册 clinicaltrials.gov标识符：NCT00326612。
