儿科重症患者中程序化镇静撤药与常规护理的比较：一项初步随机对照试验
Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial.
作者信息
Tiacharoen Duangtip, Lertbunrian Rojjanee, Veawpanich Jarin, Suppalarkbunlue Nattanicha, Anantasit Nattachai
机构信息
Division of Pediatric Critical Care, Department of Pediatrics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Division of Pediatric Critical Care, Department of Pediatrics, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand.
Division of Pediatric Critical Care, Department of Pediatrics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
出版信息
Indian J Crit Care Med. 2020 Jun;24(6):451-458. doi: 10.5005/jp-journals-10071-23465.
AIMS
The prolonged use of benzodiazepines and opioids can lead to an increase in the incidence of withdrawal syndrome. One of the known risk factors is the lack of a sedative-weaning protocol. This study established a sedative-weaning protocol and compared this protocol with the usual care of weaning in high-risk critically ill children.
MATERIALS AND METHODS
This was an open-label, randomized controlled trial in a tertiary-care hospital. We recruited children aged 1 month to 18 years who had received intravenous sedative or analgesic drugs for at least 5 days. The exclusion criteria were patients who had already experienced the withdrawal syndrome. We established a weaning protocol. Eligible patients were randomly divided into the protocolized (intervention) and usual care (control) groups. The primary objective was to determine the prevalence of the withdrawal syndrome compared between two groups.
RESULTS
Thirty eligible patients were enrolled (19 in the intervention and 11 in the control group). Baseline characteristics were not significantly different between both the groups. The prevalence of the withdrawal syndrome was 84% and 81% of patients in the intervention and control group, respectively. The duration of the initial weaning phase was shorter in the intervention group than in the control group ( value = 0.026). The cumulative dose of morphine solution for rescue therapy in the intervention group was statistically lower than that in the control group ( value = 0.016).
CONCLUSION
The implementation of the sedative-weaning protocol led to a significant reduction in the percentage of withdrawal days and length of intensive care unit stay without any adverse drug reactions. External validation would be needed to validate this protocol.
CLINICALTRIALSGOV IDENTIFIER
NCT03018977.
HOW TO CITE THIS ARTICLE
Tiacharoen D, Lertbunrian R, Veawpanich J, Suppalarkbunlue N, Anantasit N. Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial. Indian J Crit Care Med 2020;24(6):451-458.
目的
长期使用苯二氮䓬类药物和阿片类药物会导致戒断综合征的发生率增加。已知的危险因素之一是缺乏镇静剂撤药方案。本研究制定了一种镇静剂撤药方案，并将该方案与高危重症儿童的常规撤药护理进行比较。
材料与方法
这是一项在三级护理医院进行的开放标签随机对照试验。我们招募了年龄在1个月至18岁之间、接受静脉镇静或镇痛药物治疗至少5天的儿童。排除标准是已经经历过戒断综合征的患者。我们制定了撤药方案。符合条件的患者被随机分为方案组（干预组）和常规护理组（对照组）。主要目的是确定两组之间戒断综合征的患病率。
结果
共纳入30例符合条件的患者（干预组19例，对照组11例）。两组的基线特征无显著差异。干预组和对照组患者戒断综合征的患病率分别为84%和81%。干预组初始撤药阶段的持续时间比对照组短（值=0.026）。干预组用于抢救治疗的吗啡溶液累积剂量在统计学上低于对照组（值=0.016）。
结论
实施镇静剂撤药方案可显著降低戒断天数的百分比和重症监护病房住院时间，且无任何药物不良反应。需要进行外部验证以验证该方案。
临床试验注册编号
NCT03018977。
如何引用本文
Tiacharoen D, Lertbunrian R, Veawpanich J, Suppalarkbunlue N, Anantasit N. Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial. Indian J Crit Care Med 2020;24(6):451 - 458.
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