Effects of morphine analgesia in ventilated preterm neonates: primary outcomes from the NEOPAIN randomised trial
Effects of morphine analgesia in ventilated preterm neonates: primary outcomes from the NEOPAIN randomised trial
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DOI：
10.1016/s0140-6736(04)16251-x
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发表时间：
2004-05-22
期刊：
影响因子：
168.9
通讯作者：
Barton, BA
中科院分区：
文献类型：
--
作者：
Anand, KJS;Hall, RW;Barton, BA
背景阿片类镇痛通常用于新生儿重症监护。我们进行了神经学结果和先行镇痛在新生儿中的试验(NEOPAIN)，以调查先行吗啡镇痛是否降低早产儿新生儿死亡、严重脑室出血(IVH)和脑室周围白质软化(PVL)的综合主要结局的发生率。方法来自16个中心的898名早产儿随机分为面罩安慰剂(n=449)和吗啡(n=449)输注。在负荷量(100µg/kg)后，只要临床合理(最长14天)，持续注射吗啡(孕23~26周10µg kg(-1)h(-1)；27~29周20µg kg(-1)h(-1)；30~32周30µg kg(-1)h(-1))。临床判断可给予开放标记吗啡(安慰剂组242/443[54.6%]，吗啡组202/446[45.3%])。分析是通过意向处理进行的。结果基线变量在随机组中相似。安慰剂组和吗啡组的综合结局(105/408[26%]比115/419[27%])、新生儿死亡(47/449[11%]比58/449[13%])、重度IVH(46/429[11%]比55/411[13%])和PVL(34/367[9%]比27/367[7%])的发生率相似。对于没有给予开放标记吗啡的新生儿，吗啡组的综合结局(53/225[24%]比27/179[15%]，p=00338)和严重IVH的发生率(19/219[9%]比6/189[3%]，p=0.0209)高于安慰剂组。接受开放标记吗啡治疗的安慰剂组新生儿的综合结局发生率低于未接受开放标记吗啡治疗的新生儿(78/228[34%]vs 27/179[15%]，p
Background Opioid analgesia is commonly used during neonatal intensive care. We undertook the Neurologic Outcomes and Pre-emptive Analgesia in Neonates (NEOPAIN) trial to investigate whether pre-emptive morphine analgesia decreases the rate of a composite primary outcome of neonatal death, severe intraventricular haemorrhage (IVH), and periventricular leucomalacia (PVL) in preterm neonates.Methods Ventilated preterm neonates (n=898) from 16 centres were randomly assigned masked placebo (n=449) or morphine (n=449) infusions. After a loading dose (100 mug/kg), morphine infusions (23-26 weeks of gestation 10 mug kg(-1) h(-1); 27-29 weeks 20 mug kg(-1) h(-1); 30-32 weeks 30 mug kg(-1) h(-1)) were continued as long as clinically justified (maximum 14 days). Open-label morphine could be given on clinical judgment (placebo group 242/443 [54.6%], morphine group 202/446 [45.3%]). Analyses were by intention to treat.Findings Baseline variables were similar in the randomised groups. The placebo and morphine groups had similar rates of the composite outcome (105/408 [26%] vs 115/419 [27%]), neonatal death (47/449 [11%] vs 58/449 [13%]), severe IVH (46/429 [11%] vs 55/411 [13%]), and PVL (34/367 [9%] vs 27/367 [7%]). For neonates who were not given open-label morphine, rates of the composite outcome (53/225 [24%] vs 27/179 [15%], p=00338) and severe IVH (19/219 [9%] vs 6/189 [3%], p=0.0209) were higher in the morphine group than the placebo group. Placebo-group neonates receiving open-label morphine had worse rates of the composite outcome than those not receiving open-label morphine (78/228 [34%] vs 27/179 [15%], p