Department of Neonatology and Paediatric Intensive Care, Childrens Hospital, University Hospital of Cologne, Kerpener Str. 62, 50937 Cologne, Germany.
Intensive Care Med. 2012 Jun;38(6):1017-24. doi: 10.1007/s00134-012-2532-1. Epub 2012 Mar 29.
Common opioids for analgesia and sedation of mechanically ventilated infants may tend to accumulate and cause prolonged sedation with an unpredictable extubation time. Remifentanil is a promising option due to its unique pharmacokinetic properties, which seem to be valid in adults as well as in infants.
In this double-blind, randomized, controlled trial mechanically ventilated neonates and young infants (<60 days) received either a remifentanil or fentanyl-based analgesia and sedation regimen with low dose midazolam. The primary endpoint of the trial was the extubation time following discontinuation of the opioid infusion. Secondary endpoints included efficacy and safety aspects.
Between November 2006 and March 2010, we screened 431 mechanically ventilated infants for eligibility. The intention to treat group included 23 infants who were assigned to receive either remifentanil (n = 11) or fentanyl (n = 12). Although this was designed as a pilot study, median extubation time was significantly shorter in the remifentanil group (80.0 min, IQR = 15.0-165.0) compared to the fentanyl group (782.5 min, IQR = 250.8-1,875.0) (p = 0.005). Remifentanil and fentanyl provided comparable efficacy with more than two-thirds of the measurements indicating optimal analgesia and sedation (66.4 and 70.2 %, respectively; p = 0.743). Overall, both groups had good hemodynamic stability and a comparably low incidence of adverse events.
As neonates and young infants have a decreased metabolism of common opioids like fentanyl and are more prone to respiratory depression, remifentanil could be the ideal opioid for analgesia and sedation of mechanically ventilated infants.
用于镇痛和镇静机械通气婴儿的常用阿片类药物可能会倾向于积累并导致长时间镇静，且拔管时间不可预测。瑞芬太尼是一种很有前途的选择，因为它具有独特的药代动力学特性，这些特性在成人和婴儿中似乎都是有效的。
在这项双盲、随机、对照试验中，机械通气的新生儿和小婴儿（<60 天）接受了瑞芬太尼或芬太尼为基础的镇痛和镇静方案，并给予低剂量咪达唑仑。试验的主要终点是停止输注阿片类药物后拔管时间。次要终点包括疗效和安全性方面。
在 2006 年 11 月至 2010 年 3 月期间，我们对 431 名接受机械通气的婴儿进行了资格筛选。意向治疗组纳入了 23 名婴儿，他们被分配接受瑞芬太尼（n=11）或芬太尼（n=12）治疗。尽管这是一项初步研究，但瑞芬太尼组的中位拔管时间明显短于芬太尼组（80.0 分钟，IQR=15.0-165.0 与 782.5 分钟，IQR=250.8-1875.0，p=0.005）。瑞芬太尼和芬太尼的疗效相当，超过三分之二的测量结果表明镇痛和镇静效果最佳（分别为 66.4%和 70.2%，p=0.743）。总的来说，两组的血流动力学均稳定，不良事件发生率较低。
由于新生儿和小婴儿对芬太尼等常用阿片类药物的代谢减少，且更容易发生呼吸抑制，因此瑞芬太尼可能是机械通气婴儿镇痛和镇静的理想阿片类药物。
