Evaluation of Modified Fasting Protocols to Shorten Fasting Time Before Sedation in Children: A Prospective Randomized Noninferiority Trial.

IF 1.7 4区医学 Q2 ANESTHESIOLOGY

Pediatric Anesthesia Pub Date : 2025-06-18 DOI:10.1111/pan.15142

Eunah Cho, Jinyoung Song, June Huh, I-Seok Kang, Hyun Ju Kim, In Young Youn, Hyebin Lee, Ji Hee Kwak

{"title":"Evaluation of Modified Fasting Protocols to Shorten Fasting Time Before Sedation in Children: A Prospective Randomized Noninferiority Trial.","authors":"Eunah Cho, Jinyoung Song, June Huh, I-Seok Kang, Hyun Ju Kim, In Young Youn, Hyebin Lee, Ji Hee Kwak","doi":"10.1111/pan.15142","DOIUrl":null,"url":null,"abstract":"Backgrounds: Guidelines for fasting before procedural sedation aim to prevent pulmonary aspiration and are primarily targeted for deep sedation. Our study explored whether a shortened fasting protocol is noninferior to the standard protocol by comparing gastric contents evaluated by ultrasound.Methods: Pediatric patients aged < 3 years, scheduled for elective transthoracic echocardiography under sedation, were randomly allocated to a standard group (4-h fasting) or a modified group (4-h fasting for solid and 1-h fasting for water). Gastric ultrasound was performed to evaluate cross-sectional area (CSA) in supine and right lateral decubitus positions (RLDP), with the upper body elevated at 45°. The primary outcome was the CSA-RLDP (CSARLDP 45). A noninferiority test was performed applying the delta (Δ) of 2.1.Results: The noninferiority test showed that the modified fasting protocol was noninferior to the standard fasting protocol in terms of CSARLDP 45, with a mean difference (95% confidence interval) of 0.16 (-0.55 to 0.87) within the noninferiority range of delta.Conclusion: The modified fasting protocol was noninferior to the standard in pediatric patients undergoing sedation for transthoracic echocardiography, as assessed by gastric ultrasound.Trial registration: ClinicalTrials.gov identifier: NCT05810532.","PeriodicalId":19745,"journal":{"name":"Pediatric Anesthesia","volume":" ","pages":""},"PeriodicalIF":1.7000,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Anesthesia","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/pan.15142","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Backgrounds: Guidelines for fasting before procedural sedation aim to prevent pulmonary aspiration and are primarily targeted for deep sedation. Our study explored whether a shortened fasting protocol is noninferior to the standard protocol by comparing gastric contents evaluated by ultrasound.

Methods: Pediatric patients aged < 3 years, scheduled for elective transthoracic echocardiography under sedation, were randomly allocated to a standard group (4-h fasting) or a modified group (4-h fasting for solid and 1-h fasting for water). Gastric ultrasound was performed to evaluate cross-sectional area (CSA) in supine and right lateral decubitus positions (RLDP), with the upper body elevated at 45°. The primary outcome was the CSA-RLDP (CSA_{RLDP 45}). A noninferiority test was performed applying the delta (Δ) of 2.1.

Results: The noninferiority test showed that the modified fasting protocol was noninferior to the standard fasting protocol in terms of CSA_{RLDP 45}, with a mean difference (95% confidence interval) of 0.16 (-0.55 to 0.87) within the noninferiority range of delta.

Conclusion: The modified fasting protocol was noninferior to the standard in pediatric patients undergoing sedation for transthoracic echocardiography, as assessed by gastric ultrasound.

Trial registration: ClinicalTrials.gov identifier: NCT05810532.

查看原文本刊更多论文

评估改进禁食方案以缩短儿童镇静前禁食时间：一项前瞻性随机非劣效性试验。

背景：手术镇静前禁食指南旨在防止肺误吸，主要针对深度镇静。我们的研究通过比较超声评估的胃内容物来探讨缩短禁食方案是否优于标准方案。方法：年龄为RLDP 45岁的儿童患者。应用delta （Δ） 2.1进行非劣效性检验。结果：非劣效性检验显示，改良的禁食方案在CSARLDP 45方面不逊于标准禁食方案，在delta的非劣效性范围内，平均差值（95%置信区间）为0.16（-0.55 ~ 0.87）。结论：经胃超声评估，改良禁食方案不低于经胸超声心动图镇静儿科患者的标准。试验注册：ClinicalTrials.gov标识符：NCT05810532。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Pediatric Anesthesia 医学-麻醉学

CiteScore

3.20

自引率

11.80%

发文量

222

审稿时长

3-8 weeks

期刊介绍： Devoted to the dissemination of research of interest and importance to practising anesthetists everywhere, the scientific and clinical content of Pediatric Anesthesia covers a wide selection of medical disciplines in all areas relevant to paediatric anaesthesia, pain management and peri-operative medicine. The International Editorial Board is supported by the Editorial Advisory Board and a team of Senior Advisors, to ensure that the journal is publishing the best work from the front line of research in the field. The journal publishes high-quality, relevant scientific and clinical research papers, reviews, commentaries, pro-con debates, historical vignettes, correspondence, case presentations and book reviews.