{"title":"Atropine Versus Placebo for Neonatal Nonemergent Intubation: A Randomized Clinical Trial","authors":"Jehier Afifi MBBCh, MSc , Walid El-Naggar MD , Tara Hatfield RN , Navjot Sandila MPH , John Baier MD , Micheal Narvey MD","doi":"10.1016/j.jpeds.2025.114719","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>To compare the rates of severe bradycardia (<80/min for >10 seconds) between neonates who received atropine-fentanyl-succinylcholine (atropine/standard-of-care group) vs placebo-fentanyl-succinylcholine (placebo/intervention group) before orotracheal intubation.</div></div><div><h3>Study design</h3><div>A multicenter, double-blind, randomized clinical trial of neonates receiving nonemergent intubation. Randomization was by computer generated tables with random block size, stratified by postmenstrual age at randomization (<34 weeks and ≥34 weeks). The primary outcome was severe bradycardia during the whole procedure (from administration of the study medication until completion of last successful intubation). Secondary outcomes included any bradycardia (<100/min for >10 seconds), number and duration of intubation attempts and hypoxemia (<80% for >10 seconds). Safety outcomes included profound bradycardia (<60/min for >10 seconds), and receipt of chest compression or epinephrine. Analysis was by intention to treat.</div></div><div><h3>Results</h3><div>Seventy-three intubation events (60 infants) were randomized to administration of atropine (n = 24) or placebo (n = 49). Multiple attempts occurred in 33% of the events. No safety events occurred in either group. Severe bradycardia during the whole procedure was significantly higher in the placebo group compared with the atropine group (RR, 6.3; 95% CI, 1.2-34.1). The placebo group had significantly higher rates and duration of overall bradycardia, but lower rates and duration of hypoxemia compared with the atropine group, probably related to the lower proportion of multiple attempts (27% vs 46%; <em>P</em> = .09) and longer time to successful intubation (394 seconds vs 283 seconds; <em>P</em> = .08).</div></div><div><h3>Conclusions</h3><div>Among neonates receiving premedication for nonemergent intubation, atropine significantly decreased the rates and duration of severe and overall bradycardia compared with placebo.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov: <span><span>NCT01595399</span><svg><path></path></svg></span> (<span><span>https://clinicaltrials.gov/study/NCT01595399</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":54774,"journal":{"name":"Journal of Pediatrics","volume":"286 ","pages":"Article 114719"},"PeriodicalIF":3.5000,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pediatrics","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0022347625002604","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}
引用次数: 0
Abstract
Objective
To compare the rates of severe bradycardia (<80/min for >10 seconds) between neonates who received atropine-fentanyl-succinylcholine (atropine/standard-of-care group) vs placebo-fentanyl-succinylcholine (placebo/intervention group) before orotracheal intubation.
Study design
A multicenter, double-blind, randomized clinical trial of neonates receiving nonemergent intubation. Randomization was by computer generated tables with random block size, stratified by postmenstrual age at randomization (<34 weeks and ≥34 weeks). The primary outcome was severe bradycardia during the whole procedure (from administration of the study medication until completion of last successful intubation). Secondary outcomes included any bradycardia (<100/min for >10 seconds), number and duration of intubation attempts and hypoxemia (<80% for >10 seconds). Safety outcomes included profound bradycardia (<60/min for >10 seconds), and receipt of chest compression or epinephrine. Analysis was by intention to treat.
Results
Seventy-three intubation events (60 infants) were randomized to administration of atropine (n = 24) or placebo (n = 49). Multiple attempts occurred in 33% of the events. No safety events occurred in either group. Severe bradycardia during the whole procedure was significantly higher in the placebo group compared with the atropine group (RR, 6.3; 95% CI, 1.2-34.1). The placebo group had significantly higher rates and duration of overall bradycardia, but lower rates and duration of hypoxemia compared with the atropine group, probably related to the lower proportion of multiple attempts (27% vs 46%; P = .09) and longer time to successful intubation (394 seconds vs 283 seconds; P = .08).
Conclusions
Among neonates receiving premedication for nonemergent intubation, atropine significantly decreased the rates and duration of severe and overall bradycardia compared with placebo.
期刊介绍:
The Journal of Pediatrics is an international peer-reviewed journal that advances pediatric research and serves as a practical guide for pediatricians who manage health and diagnose and treat disorders in infants, children, and adolescents. The Journal publishes original work based on standards of excellence and expert review. The Journal seeks to publish high quality original articles that are immediately applicable to practice (basic science, translational research, evidence-based medicine), brief clinical and laboratory case reports, medical progress, expert commentary, grand rounds, insightful editorials, “classic” physical examinations, and novel insights into clinical and academic pediatric medicine related to every aspect of child health. Published monthly since 1932, The Journal of Pediatrics continues to promote the latest developments in pediatric medicine, child health, policy, and advocacy.
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