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瑞芬太尼与吗啡-咪达唑仑预给药对新生儿气管插管质量的影响:一项非劣效性随机试验。

Remifentanil versus morphine-midazolam premedication on the quality of endotracheal intubation in neonates: a noninferiority randomized trial.

机构信息

Neonatal Intensive Care Unit, Hôpital Universitaire des Enfants Reine Fabiola, Brussels, Belgium.

Epidemiology, Biostatistics and Clinical Research Center, School of Public Health, Université Libre de Bruxelles, Brussels, Belgium.

出版信息

J Pediatr. 2014 May;164(5):1032-7. doi: 10.1016/j.jpeds.2014.01.030. Epub 2014 Feb 25.

Abstract

OBJECTIVE

To compare remifentanil and morphine-midazolam for use in nonurgent endotracheal intubation in neonates.

STUDY DESIGN

In this prospective noninferiority randomized trial, newborns of gestational age ≥28 weeks admitted in the neonatal intensive care unit requiring an elective or semielective endotracheal intubation were divided into 2 groups. One group (n = 36) received remifentanil (1 μg/kg), and the other group (n = 35) received morphine (100 μg/kg) and midazolam (50 μg/kg) at a predefined time before intubation (different in each group), to optimize the peak effect of each drug. Both groups also received atropine (20 μg/kg). The primary outcome was to compare the conditions of intubation, and the secondary outcome was to compare the duration of successful intubation, physiological variables, and pain scores between groups for first and second intubation attempts. Adverse events and neurologic test data were reported.

RESULTS

Intubation with remifentanil was not inferior to that with morphine-midazolam. At the first attempted intubation, intubation conditions were poor in 25% of the remifentanil group and in 28.6% of the morphine-midazolam group (P = .471). For the second attempt, conditions were poor in 28.6% of the remifentanil group, compared with 10% of the morphine-midazolam group (P = .360). The median time to successful intubation was 33 seconds (IQR, 24-45 seconds) for the remifentanil group versus 36 seconds (IQR, 25-59 seconds) for the morphine-medazolam group (P = .359) at the first attempt and 45 seconds (IQR, 35-64 seconds) versus 56 seconds (IQR, 44-68 seconds), respectively, for the second attempt (P = .302). No significant between-group difference was reported for hypotension, bradycardia, or adverse events.

CONCLUSION

In our cohort, remifentanil was at least as effective as the morphine-midazolam regimen for endotracheal intubation. Thus, premedication using this very-short-acting opioid can be considered in urgent intubations and is advantageous in rapid extubation.

摘要

目的

比较瑞芬太尼和吗啡-咪达唑仑在非紧急气管插管中的应用。

研究设计

在这项前瞻性非劣效性随机试验中,将胎龄≥28 周、需要择期或半择期气管插管的新生儿重症监护病房的新生儿分为两组。一组(n=36)接受瑞芬太尼(1μg/kg),另一组(n=35)在插管前的预定义时间接受吗啡(100μg/kg)和咪达唑仑(50μg/kg),以优化每种药物的峰值效应。两组均给予阿托品(20μg/kg)。主要结局是比较插管条件,次要结局是比较两组首次和第二次插管尝试的成功插管时间、生理变量和疼痛评分。报告不良事件和神经测试数据。

结果

瑞芬太尼插管并不劣于吗啡-咪达唑仑。在第一次尝试插管时,瑞芬太尼组插管条件差的比例为 25%,吗啡-咪达唑仑组为 28.6%(P=.471)。第二次尝试时,瑞芬太尼组条件差的比例为 28.6%,而吗啡-咪达唑仑组为 10%(P=.360)。瑞芬太尼组成功插管的中位数时间为 33 秒(IQR,24-45 秒),吗啡-咪达唑仑组为 36 秒(IQR,25-59 秒)(P=.359)。第一次尝试时,瑞芬太尼组的中位数时间为 45 秒(IQR,35-64 秒),吗啡-咪达唑仑组为 56 秒(IQR,44-68 秒)(P=.302)。低血压、心动过缓或不良事件在两组间无显著差异。

结论

在我们的队列中,瑞芬太尼在气管插管方面至少与吗啡-咪达唑仑方案一样有效。因此,在紧急插管时可以考虑使用这种超短效阿片类药物进行预用药,并且有利于快速拔管。

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