Vet Nienke J, de Wildt Saskia N, Verlaat Carin W M, Knibbe Catherijne A J, Mooij Miriam G, van Woensel Job B M, van Rosmalen Joost, Tibboel Dick, de Hoog Matthijs
Intensive Care, Erasmus MC - Sophia Children's Hospital, Dr. Molewaterplein 60, 3015 GJ, Rotterdam, The Netherlands.
Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.
Intensive Care Med. 2016 Feb;42(2):233-44. doi: 10.1007/s00134-015-4136-z. Epub 2015 Nov 24.
To compare daily sedation interruption plus protocolized sedation (DSI + PS) to protocolized sedation only (PS) in critically ill children.
In this multicenter randomized controlled trial in three pediatric intensive care units in the Netherlands, mechanically ventilated critically ill children with need for sedative drugs were included. They were randomly assigned to either DSI + PS or PS only. Children in both study arms received sedation adjusted on the basis of validated sedation scores. Provided a safety screen was passed, children in the DSI + PS group received daily blinded infusions of saline; children in the PS group received blinded infusions of the previous sedatives/analgesics. If a patient's sedation score indicated distress, the blinded infusions were discontinued, a bolus dose of midazolam was given and the 'open' infusions were resumed: DSI + PS at half of infusion rate, PS at previous infusion rate. The primary endpoint was the number of ventilator-free days at day 28. Data were analyzed by intention to treat.
From October 2009 to August 2014, 129 children were randomly assigned to DSI + PS (n = 66) or PS (n = 63). The study was terminated prematurely due to slow recruitment rates. Median number of ventilator-free days did not differ: DSI + PS 24.0 days (IQR 21.6-25.8) versus PS 24.0 days (IQR 20.6-26.0); median difference 0.02 days (95 % CI -0.91 to 1.09), p = 0.90. Median ICU and hospital length of stay were similar in both groups: DSI + PS 6.9 days (IQR 5.2-11.0) versus PS 7.4 days (IQR 5.3-12.8), p = 0.47, and DSI + PS 13.3 days (IQR 8.6-26.7) versus PS 15.7 days (IQR 9.3-33.2), p = 0.19, respectively. Mortality at 30 days was higher in the DSI + PS group than in the PS group (6/66 versus 0/63, p = 0.03), though no causal relationship to the intervention could be established. Median cumulative midazolam dose did not differ: DSI + PS 14.1 mg/kg (IQR 7.6-22.6) versus PS 17.0 mg/kg (IQR 8.2-39.8), p = 0.11.
In critically ill children, daily sedation interruption in addition to protocolized sedation did not improve clinical outcome and was associated with increased mortality compared with protocolized sedation only.
比较每日镇静中断联合程序化镇静（DSI + PS）与单纯程序化镇静（PS）在危重症儿童中的效果。
在荷兰三个儿科重症监护病房进行的这项多中心随机对照试验中，纳入了需要使用镇静药物的机械通气危重症儿童。他们被随机分为DSI + PS组或单纯PS组。两个研究组的儿童均根据经过验证的镇静评分来调整镇静方案。若通过安全筛查，DSI + PS组的儿童每日接受生理盐水的盲法输注；PS组的儿童接受之前使用的镇静剂/镇痛药的盲法输注。如果患者的镇静评分显示有痛苦，则停止盲法输注，给予一剂咪达唑仑推注，然后恢复“开放”输注：DSI + PS组以输注速率的一半恢复，PS组以之前的输注速率恢复。主要终点是第28天无呼吸机天数。数据采用意向性分析。
2009年10月至2014年8月，129名儿童被随机分配至DSI + PS组（n = 66）或PS组（n = 63）。由于入组率低，研究提前终止。无呼吸机天数的中位数无差异：DSI + PS组为24.0天（IQR为21.6 - 25.8），PS组为24.0天（IQR为20.6 - 26.0）；中位数差异为0.02天（95%CI为 - 0.91至1.09），p = 0.90。两组的重症监护病房（ICU）和住院时间中位数相似：DSI + PS组为6.9天（IQR为5.2 - 11.0），PS组为7.4天（IQR为5.3 - 12.8），p = 0.47；DSI + PS组为13.3天（IQR为8.6 - 26.7），PS组为15.7天（IQR为9.3 - 33.2），p = 0.19。DSI + PS组30天死亡率高于PS组（6/66对0/63，p = 0.03），但无法确定与干预措施有因果关系。咪达唑仑累积剂量中位数无差异：DSI + PS组为14.1mg/kg（IQR为7.6 - 22.6），PS组为17.0mg/kg（IQR为8.2 - 39.8），p = 0.11。
在危重症儿童中，与单纯程序化镇静相比，每日镇静中断联合程序化镇静并未改善临床结局，且与死亡率增加相关。
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