Ariane Ballard, Christelle Khadra, Olivier Fortin, Estelle Guingo, Evelyne D Trottier, Benoit Bailey, Naveen Poonai, Sylvie Le May
{"title":"Cold and vibration for children undergoing needle-related procedures: A non-inferiority randomized clinical trial.","authors":"Ariane Ballard, Christelle Khadra, Olivier Fortin, Estelle Guingo, Evelyne D Trottier, Benoit Bailey, Naveen Poonai, Sylvie Le May","doi":"10.1002/pne2.12125","DOIUrl":null,"url":null,"abstract":"<p><p>The use of a rapid, easy-to-use intervention could improve needle-related procedural pain management practices in the context of the Emergency Department (ED). As such, the Buzzy device seems to be a promising alternative to topical anesthetics. The aim of this study was to determine if a cold vibrating device was non-inferior to a topical anesthetic cream for pain management in children undergoing needle-related procedures in the ED. In this randomized controlled non-inferiority trial, we enrolled children between 4 and 17 years presenting to the ED and requiring a needle-related procedure. Participants were randomly assigned to either the cold vibrating device or topical anesthetic (4% liposomal lidocaine; standard of care). The primary outcome was the mean difference (MD) in adjusted procedural pain intensity on the 0-10 Color Analogue Scale (CAS), using a non-inferiority margin of 0.70. A total of 352 participants were randomized (cold vibration device <i>n</i> = 176, topical anesthetic cream <i>n</i> = 176). Adjusted procedural pain scores' MD between groups was 0.56 (95% CI:-0.08-1.20) on the CAS, showing that the cold vibrating device was not considered non-inferior to topical anesthetic. The cold vibrating device was not considered non-inferior to the topical anesthetic cream for pain management in children during a needle-related procedure in the ED. As topical anesthetic creams require an application time of 30 min, cost approximately CAD $40.00 per tube, are underused in the ED setting, the cold vibrating device remains a promising alternative as it is a rapid, easy-to-use, and reusable device.</p>","PeriodicalId":94166,"journal":{"name":"Paediatric & neonatal pain","volume":"6 4","pages":"164-173"},"PeriodicalIF":0.0000,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11645969/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Paediatric & neonatal pain","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/pne2.12125","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/12/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
The use of a rapid, easy-to-use intervention could improve needle-related procedural pain management practices in the context of the Emergency Department (ED). As such, the Buzzy device seems to be a promising alternative to topical anesthetics. The aim of this study was to determine if a cold vibrating device was non-inferior to a topical anesthetic cream for pain management in children undergoing needle-related procedures in the ED. In this randomized controlled non-inferiority trial, we enrolled children between 4 and 17 years presenting to the ED and requiring a needle-related procedure. Participants were randomly assigned to either the cold vibrating device or topical anesthetic (4% liposomal lidocaine; standard of care). The primary outcome was the mean difference (MD) in adjusted procedural pain intensity on the 0-10 Color Analogue Scale (CAS), using a non-inferiority margin of 0.70. A total of 352 participants were randomized (cold vibration device n = 176, topical anesthetic cream n = 176). Adjusted procedural pain scores' MD between groups was 0.56 (95% CI:-0.08-1.20) on the CAS, showing that the cold vibrating device was not considered non-inferior to topical anesthetic. The cold vibrating device was not considered non-inferior to the topical anesthetic cream for pain management in children during a needle-related procedure in the ED. As topical anesthetic creams require an application time of 30 min, cost approximately CAD $40.00 per tube, are underused in the ED setting, the cold vibrating device remains a promising alternative as it is a rapid, easy-to-use, and reusable device.