Hôpital Armand Trousseau, Service des Urgences Pédiatriques, Faculté de Médecine, Paris, France; INSERM U1153, Faculté de Médecine, Paris, France; Université Pierre et Marie Curie, Faculté de Médecine, Paris, France.
Örebro University, Faculty of Medicine and Health, Örebro, Sweden.
Lancet Respir Med. 2015 Oct;3(10):796-812. doi: 10.1016/S2213-2600(15)00331-8. Epub 2015 Sep 24.
Neonates who are in pain or are stressed during care in the intensive care unit (ICU) are often given sedation or analgesia. We investigated the current use of sedation or analgesia in neonatal ICUs (NICUs) in European countries.
EUROPAIN (EUROpean Pain Audit In Neonates) was a prospective cohort study of the management of sedation and analgesia in patients in NICUs. All neonates admitted to NICUs during 1 month were included in this study. Data on demographics, methods of respiration, use of continuous or intermittent sedation, analgesia, or neuromuscular blockers, pain assessments, and drug withdrawal syndromes were gathered during the first 28 days of admission to NICUs. Multivariable linear regression models and propensity scores were used to assess the association between duration of tracheal ventilation (TV) and exposure to opioids, sedatives-hypnotics, or general anaesthetics in neonates (O-SH-GA). This study is registered with ClinicalTrials.gov, number NCT01694745.
From Oct 1, 2012, to June 30, 2013, 6680 neonates were enrolled in 243 NICUs in 18 European countries. Mean gestational age of these neonates was 35.0 weeks (SD 4.6) and birthweight was 2384 g (1007). 2142 (32%) neonates were given TV, 1496 (22%) non-invasive ventilation (NIV), and 3042 (46%) were kept on spontaneous ventilation (SV). 1746 (82%), 266 (18%), and 282 (9%) neonates in the TV, NIV, and SV groups, respectively, were given sedation or analgesia as a continuous infusion, intermittent doses, or both (p<0.0001). In the participating NICUs, the median use of sedation or analgesia was 89.3% (70.0-100) for neonates in the TV group. Opioids were given to 1764 (26%) of 6680 neonates and to 1589 (74%) of 2142 neonates in the TV group. Midazolam was given to 576 (9%) of 6680 neonates and 536 (25%) neonates of 2142 neonates in the TV group. 542 (25%) neonates in the TV group were given neuromuscular blockers, which were administered as continuous infusions to 146 (7%) of these neonates. Pain assessments were recorded in 1250 (58%) of 2138, 672 (45%) of 1493, and 916 (30%) of 3017 neonates in the TV, NIV, and SV groups, respectively (p<0.0001). In the univariate analysis, neonates given O-SH-GA in the TV group needed a longer duration of TV than did those who were not given O-SH-GA (mean 136.2 h [SD 173.1] vs 39.8 h [94.7] h; p<0.0001). Multivariable and propensity score analyses confirmed this association (p<0.0001).
Wide variations in sedation and analgesia practices occur between NICUs and countries. Widespread use of O-SH-GA in intubated neonates might prolong their need for mechanical ventilation, but further research is needed to investigate the therapeutic and adverse effects of O-SH-GA in neonates, and to develop new and safe approaches for sedation and analgesia.
European Community's Seventh Framework Programme.
在重症监护病房（ICU）接受护理的疼痛或应激的新生儿通常会接受镇静或镇痛。我们调查了欧洲国家新生儿 ICU（NICU）中镇静和镇痛的使用情况。
EUROPAIN（欧洲新生儿疼痛评估）是一项对 NICU 患者镇静和镇痛管理的前瞻性队列研究。这项研究纳入了在 1 个月期间入住 NICU 的所有新生儿。在入住 NICU 的前 28 天内收集了人口统计学数据、呼吸方式、持续或间歇性镇静、镇痛或神经肌肉阻滞剂的使用、疼痛评估和药物戒断综合征的数据。多变量线性回归模型和倾向评分用于评估气管插管通气（TV）时间与接受阿片类药物、镇静剂-催眠剂或全身麻醉的时间之间的关联（O-SH-GA）。这项研究在 ClinicalTrials.gov 注册，编号为 NCT01694745。
从 2012 年 10 月 1 日至 2013 年 6 月 30 日，共有 6680 名新生儿纳入了 18 个欧洲国家的 243 个 NICU。这些新生儿的平均胎龄为 35.0 周（SD 4.6），出生体重为 2384 克（1007）。2142 名（32%）新生儿接受了 TV，1496 名（22%）接受了无创通气（NIV），3042 名（46%）接受了自主通气（SV）。在 TV、NIV 和 SV 组中，1746（82%）、266（18%）和 282（9%）名新生儿分别给予镇静或镇痛的持续输注、间歇性剂量或两者（p<0.0001）。在参与的 NICU 中，接受 TV 的新生儿中镇静或镇痛的中位使用率为 89.3%（70.0-100）。6680 名新生儿中有 1764 名（26%）接受了阿片类药物，其中 2142 名 TV 组新生儿中有 1589 名（74%）接受了阿片类药物。6680 名新生儿中有 576 名（9%）接受了咪达唑仑，其中 2142 名 TV 组新生儿中有 536 名（25%）接受了咪达唑仑。TV 组中有 542 名（25%）新生儿接受了神经肌肉阻滞剂，其中 146 名（7%）新生儿连续输注神经肌肉阻滞剂。在 TV、NIV 和 SV 组中，分别有 1250 名（58%）、672 名（45%）和 916 名（30%）新生儿记录了疼痛评估（p<0.0001）。在单变量分析中，与未接受 O-SH-GA 的新生儿相比，接受 O-SH-GA 的 TV 组新生儿需要更长的 TV 时间（平均 136.2 h [SD 173.1] vs 39.8 h [94.7] h；p<0.0001）。多变量和倾向评分分析证实了这种关联（p<0.0001）。
NICU 和国家之间的镇静和镇痛实践存在广泛差异。在气管插管的新生儿中广泛使用 O-SH-GA 可能会延长他们对机械通气的需求，但需要进一步研究以调查 O-SH-GA 在新生儿中的治疗和不良影响，并开发新的安全镇静和镇痛方法。
欧洲共同体第七框架计划。
