Early versus late switch over of antiseizure medications from intravenous to the oral route in children with seizures: Single-blinded, randomized controlled trial (ELAIO trial)

IF 2 4区医学 Q3 CLINICAL NEUROLOGY Epilepsy Research Pub Date : 2024-04-12 DOI:10.1016/j.eplepsyres.2024.107360

Prateek Kumar Panda , Sanjot Bhardwaj , Vignesh Kaniyappan Murugan , Aman Elwadhi , Puneet Dhamija , Lokesh Tiwari , Indar Kumar Sharawat

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Abstract

Introduction

Early switch-over of anti-seizure medications (ASMs) from intravenous to oral route may reduce the duration of hospitalization, drug acquisition costs, and behavioral upset in hospitalized children with seizures.

Objective

The primary objective was to compare short-term seizure recurrence within 1 week in hospitalized children aged 1 month to 18 years with new-onset/breakthrough seizures after an early versus late switch-over from intravenous to the oral route of ASMs. Secondary objectives were to compare the incidence of status epilepticus, duration of hospital stay, drug acquisition costs, and caregiver-reported satisfaction scores in both groups.

Methods

In this single-blind randomized controlled trial, patients with seizures were categorized based on the number of ASMs required and the history of status epilepticus. Patients in each category were randomized in a 1:1 ratio into either early or late switch-over (ES or LS) groups. In the ES groups, ASMs were tapered one-by-one between 0 and 24 hours of seizure freedom, while in the LS groups, they were tapered one-by-one between 24 and 48 hours of seizure freedom.

Results

A total of 112 children were enrolled in the study, with 56 in each arm. Seizure recurrence at 1 week and 12 weeks was comparable in ES and LS groups (3/55 vs. 1/54 at 1 week, p=0.61; 7/49 vs. 6/49 at 12 weeks, p=0.98). Drug acquisition costs were significantly lower in the ES group (393±274 vs. 658±568 INR, p=0.002). Thrombophlebitis and dysphoria were significantly more common in the LS group (p=0.008 and 0.03, respectively).

Conclusion

The early switch-over of ASMs from intravenous to oral route is safe without any significant increased risk of short-term seizure recurrence and also associated with a reduction in the incidence of thrombophlebitis and ASM acquisition costs.

Trial registration No

CTRI/2021/03/032145

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癫痫发作儿童抗癫痫药物从静脉途径转为口服途径的早期与晚期对比：单盲随机对照试验（ELAIO 试验）

导言抗癫痫药物（ASMs）从静脉注射到口服途径的早期转换可减少住院儿童癫痫发作的住院时间、药物采购成本和行为不安。目的主要目的是比较1个月至18岁新发/突破性癫痫发作的住院儿童在抗癫痫药物从静脉注射到口服途径的早期和晚期转换后1周内的短期癫痫复发情况。次要目标是比较两组患者的癫痫状态发生率、住院时间、药物采购成本和护理人员报告的满意度评分。方法在这项单盲随机对照试验中，根据所需的 ASMs 数量和癫痫状态病史对癫痫发作患者进行分类。每类患者按 1:1 的比例随机分为早期或晚期转换组（ES 组或 LS 组）。在 ES 组中，ASMs 在无癫痫发作的 0 到 24 小时之间逐次递减，而在 LS 组中，ASMs 在无癫痫发作的 24 到 48 小时之间逐次递减。ES组和LS组在1周和12周时的癫痫复发率相当（1周时3/55对1/54，P=0.61；12周时7/49对6/49，P=0.98）。ES 组的药物采购成本明显较低（393±274 INR vs. 658±568 INR，p=0.002）。结论早期将 ASM 从静脉途径转换为口服途径是安全的，不会显著增加短期癫痫复发的风险，同时还降低了血栓性静脉炎的发生率和 ASM 的购置成本。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Epilepsy Research 医学-临床神经学

CiteScore

0.10

自引率

4.50%

发文量

143

审稿时长

62 days

期刊介绍： Epilepsy Research provides for publication of high quality articles in both basic and clinical epilepsy research, with a special emphasis on translational research that ultimately relates to epilepsy as a human condition. The journal is intended to provide a forum for reporting the best and most rigorous epilepsy research from all disciplines ranging from biophysics and molecular biology to epidemiological and psychosocial research. As such the journal will publish original papers relevant to epilepsy from any scientific discipline and also studies of a multidisciplinary nature. Clinical and experimental research papers adopting fresh conceptual approaches to the study of epilepsy and its treatment are encouraged. The overriding criteria for publication are novelty, significant clinical or experimental relevance, and interest to a multidisciplinary audience in the broad arena of epilepsy. Review articles focused on any topic of epilepsy research will also be considered, but only if they present an exceptionally clear synthesis of current knowledge and future directions of a research area, based on a critical assessment of the available data or on hypotheses that are likely to stimulate more critical thinking and further advances in an area of epilepsy research.