羟嗪与三氯福在儿童脑电图记录中的镇静作用：一项非劣效性随机对照试验

IF 2.1 3区医学 Q2 CLINICAL NEUROLOGY

Pediatric neurology Pub Date : 2025-06-03 DOI:10.1016/j.pediatrneurol.2025.05.028

Narmadham K. Bharathi MD, DM , Sangeetha Yoganathan MD, DNB, DM , Maya Thomas DCH, MD, DM , Annadurai Subramanian MPharm, PhD (Pharmacy) , Antonisamy Belavendra PhD , Winsley Rose MD, MSc (Epi) , Yezhilarasi Ganesan BSc (Chem)

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引用次数: 0

摘要

背景：三氯氟虫常用于儿童镇静，用于脑电图（EEG）记录。进行了一项非劣效性随机对照试验，以评估羟嗪作为镇静替代药物的有效性、安全性和可接受性。方法选取6个月~ 5岁无自然睡眠记录的儿童，按1:1的比例随机给予羟嗪或三氯福。我们的主要结果是成功的EEG完成，定义为在一小时的EEG记录中达到至少40分钟的睡眠记录。我们的次要结果是Ramsay镇静评分、镇静所需时间、第二剂量镇静剂的需要、异常脑电图记录的数量、不良事件的发生率、技术人员和护理人员满意度评分（基于李克特量表）、神经学家基于视觉模拟量表对运动伪影的评估，以及药物对背景节奏幅度和频率的影响。在接下来的24小时内，对父母进行了电话采访，询问是否有任何不良反应。结果羟嗪组EEG完成率为82.6%，三氯福组为90.2%，平均差异为−7.66（95%可信区间：−16.5 ~ 1.2,P = 0.092）。次要结果，如入睡时间、需要第二次镇静、异常脑电图记录的数量、不良反应概况、神经学家对运动伪影的分级以及对背景的影响，两组之间具有可比性。结论羟嗪可能是一种安全、可接受、有效的儿童脑电图记录替代镇静剂。

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Hydroxyzine Versus Triclofos for Sedation for Electroencephalography Recording in Children: A Noninferiority Randomized Controlled Trial

Background

Triclofos is commonly used for sedation in children for electroencephalography (EEG) recording. A noninferiority randomized controlled trial was conducted to assess the efficacy, safety, and acceptability of hydroxyzine as an alternate drug for sedation.

Methods

Children aged six months to five years who did not sleep naturally for EEG recording were randomly assigned to receive either hydroxyzine or triclofos in 1:1 ratio. Our primary outcome was successful EEG completion as defined by achieving at least 40 minutes of sleep record in a one-hour EEG recording. Our secondary outcomes were Ramsay sedation score, time taken for sedation, need for second dose of sedative agent, yield of abnormal EEG records, incidence of adverse events, technologist and caregiver satisfaction score (based on a Likert scale), neurologist assessment of motion artifacts based on a visual analog scale, and effect of the drug on the amplitude and frequency of the background rhythm. The parents were interviewed telephonically regarding any adverse effects within the next 24 hours.

Results

Successful EEG completion was achieved in 82.6% in the hydroxyzine arm and in 90.2% in the triclofos arm with a mean difference of −7.66 (95% confidence interval: −16.5 to 1.2, P = 0.092). Secondary outcomes such as time taken to sleep, need for second dose of sedation, yield of abnormal EEG records, adverse effect profile, neurologist grading of motion artifacts, and effect on background were comparable between both groups.

Conclusion

Hydroxyzine may be a safe, acceptable, and efficacious alternative sedative agent for EEG recording in children.

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来源期刊

Pediatric neurology 医学-临床神经学

CiteScore

4.80

自引率

2.60%

发文量

176

审稿时长

78 days

期刊介绍： Pediatric Neurology publishes timely peer-reviewed clinical and research articles covering all aspects of the developing nervous system. Pediatric Neurology features up-to-the-minute publication of the latest advances in the diagnosis, management, and treatment of pediatric neurologic disorders. The journal''s editor, E. Steve Roach, in conjunction with the team of Associate Editors, heads an internationally recognized editorial board, ensuring the most authoritative and extensive coverage of the field. Among the topics covered are: epilepsy, mitochondrial diseases, congenital malformations, chromosomopathies, peripheral neuropathies, perinatal and childhood stroke, cerebral palsy, as well as other diseases affecting the developing nervous system.