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肌内注射咪达唑仑与静脉注射地西泮治疗儿科急诊科癫痫发作的随机临床试验

Intramuscular midazolam versus intravenous diazepam for treatment of seizures in the pediatric emergency department: a randomized clinical trial.

作者信息

Portela J L, Garcia P C R, Piva J P, Barcelos A, Bruno F, Branco R, Tasker R C

机构信息

Pediatric Emergency Department, Hospital Universitário de Santa Maria, Universidade Federal de Santa Maria (UFSM), Av. Roraima, Prédio 22, Campus, Bairro Camobi, Zip Code: 97105 900, Santa Maria, RS, Brazil; School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS, Brazil.

Department of Pediatrics, School of Medicine, PUCRS, Brazil; Hospital São Lucas, PUCRS, Porto Alegre, RS, Brazil.

出版信息

Med Intensiva. 2015 Apr;39(3):160-6. doi: 10.1016/j.medin.2014.04.003. Epub 2014 Jun 10.

Abstract

AIM

To compare the therapeutic efficacy of intramuscular midazolam (MDZ-IM) with that of intravenous diazepam (DZP-IV) for seizures in children.

DESIGN

Randomized clinical trial.

SETTING

Pediatric emergency department.

PATIENTS

Children aged 2 months to 14 years admitted to the study facility with seizures.

INTERVENTION

Patients were randomized to receive DZP-IV or MDZ-IM.

MAIN MEASUREMENTS

Groups were compared with respect to time to treatment start (min), time from drug administration to seizure cessation (min), time to seizure cessation (min), and rate of treatment failure. Treatment was considered successful when seizure cessation was achieved within 5min of drug administration.

RESULTS

Overall, 32 children (16 per group) completed the study. Intravenous access could not be obtained within 5min in four patients (25%) in the DZP-IV group. Time from admission to active treatment and time to seizure cessation was shorter in the MDZ-IM group (2.8 versus 7.4min; p<0.001 and 7.3 versus 10.6min; p=0.006, respectively). In two children per group (12.5%), seizures continued after 10min of treatment, and additional medications were required. There were no between-group differences in physiological parameters or adverse events (p=0.171); one child (6.3%) developed hypotension in the MDZ-IM group and five (31%) developed hyperactivity or vomiting in the DZP-IV group.

CONCLUSION

Given its efficacy and ease and speed of administration, intramuscular midazolam is an excellent option for treatment of childhood seizures, enabling earlier treatment and shortening overall seizure duration. There were no differences in complications when applying MDZ-IM or DZP-IV.

摘要

目的

比较肌内注射咪达唑仑(MDZ-IM)与静脉注射地西泮(DZP-IV)治疗儿童癫痫发作的疗效。

设计

随机临床试验。

地点

儿科急诊科。

患者

2个月至14岁因癫痫发作入住研究机构的儿童。

干预措施

患者被随机分配接受DZP-IV或MDZ-IM治疗。

主要测量指标

比较两组在开始治疗时间(分钟)、给药至癫痫停止时间(分钟)、癫痫停止时间(分钟)和治疗失败率方面的差异。当给药后5分钟内癫痫停止时,治疗被认为成功。

结果

总体而言,32名儿童(每组16名)完成了研究。DZP-IV组有4名患者(25%)在5分钟内无法建立静脉通路。MDZ-IM组从入院到开始积极治疗的时间和癫痫停止时间较短(分别为2.8分钟对7.4分钟;p<0.001和7.3分钟对10.6分钟;p=0.006)。每组有两名儿童(12.5%)在治疗10分钟后癫痫仍持续,需要额外用药。两组在生理参数或不良事件方面无差异(p=0.171);MDZ-IM组有一名儿童(6.3%)出现低血压,DZP-IV组有五名儿童(31%)出现多动或呕吐。

结论

鉴于其疗效以及给药的简便性和速度,肌内注射咪达唑仑是治疗儿童癫痫发作的极佳选择,能够更早开始治疗并缩短总体癫痫发作持续时间。应用MDZ-IM或DZP-IV时并发症无差异。

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