MEOPAeDent 试验方案——一项观察性研究，评估小儿牙科中氧气和氧化亚氮等摩尔混合（EMONO）的效果。
The MEOPAeDent trial protocol-an observational study of the Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) effects in paediatric dentistry.
机构信息
Faculty of Dental Surgery, Pediatric Dentistry Department, CHU Nantes, 1 place Alexis Ricordeau, BP 84215, 44042, Nantes, Cedex 1, France.
Université Nantes, Nantes, France.
出版信息
BMC Oral Health. 2019 Mar 7;19(1):42. doi: 10.1186/s12903-019-0732-6.
BACKGROUND
Many studies were conducted to assess the benefit/risk ratio of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) in France before it was authorized for use outside the hospital setting in 2009. The main objective of this project is to evaluate the effects sought and felt by children when EMONO is used in paediatric dentistry. The secondary objectives are to (i) evaluate the appreciation of EMONO by the children, (ii) characterize children who experience both analgesia and anxiolysis, (iii) evaluate children's appetite for EMONO and characterize children with a high appetite and (iv) evaluate the impact of the difference in practice among the French dental service university hospitals on anxiety. The maintenance of a framework for the safe use of this drug, whose place in dental care is fundamental, is essential. Twelve of the 16 French dental service university hospitals agreed to participate in this study.
METHODS
MEOPAeDent is an observational, descriptive, transversal study that aims to evaluate the effects sought and felt by children when EMONO is used in paediatric dentistry. Subjects requiring dental care under EMONO are recruited by 12 French dental service university hospitals. Patients aged from 3 to 15 years are recruited for the study when they visit a dental service of a French university hospital requiring dental care under EMONO. The investigator collects the necessary data from the child's medical records, from his own observations and from questions posed to the child and his/her parents. A survey is completed at the first and final sessions of dental care under EMONO.
DISCUSSION
This study will provide an evaluation of the effects of EMONO on the French paediatric population in need of dental care as well as evaluate the appetite for the use of this substance. The results will first be used to provide additional data that is essential to monitor the use of a product with an authorization to use it outside of hospitals from 2009 in France, confirm its safety for use and justify its framework of application.
TRIAL REGISTRATION
ClinicalTrials.gov ID: NCT03453411 registered 2 March 2018.
背景
在 2009 年，EMONO（氧气和氧化亚氮等摩尔混合物）获得批准在医院环境外使用之前，法国进行了许多研究来评估其获益/风险比。本项目的主要目的是评估 EMONO 在儿科牙科中使用时儿童所寻求和感受到的效果。次要目的是：（i）评估儿童对 EMONO 的评价，（ii）确定同时具有镇痛和解焦虑作用的儿童，（iii）评估儿童对 EMONO 的需求并确定需求高的儿童，以及（iv）评估法国牙科服务大学医院之间实践差异对焦虑的影响。维持这种药物的安全使用框架至关重要，因为它在牙科护理中的地位是基础。16 家法国牙科服务大学医院中有 12 家同意参与这项研究。
方法
MEOPAeDent 是一项观察性、描述性、横断面研究，旨在评估 EMONO 在儿科牙科中使用时儿童所寻求和感受到的效果。通过 12 家法国牙科服务大学医院招募需要 EMONO 牙科护理的患者。当需要在 EMONO 下进行牙科护理的患者到法国大学医院的牙科服务就诊时，招募 3 至 15 岁的患者进行研究。研究者从患儿的病历、自身观察以及向患儿及其父母提出的问题中收集必要的数据。在 EMONO 下进行的牙科护理的第一和最后一次就诊时完成调查。
讨论
这项研究将评估 EMONO 对需要牙科护理的法国儿科人群的影响，并评估对使用这种物质的需求。研究结果将首先用于提供额外的数据，这些数据对于监测自 2009 年以来在法国获得医院外使用授权的产品的使用至关重要，以确认其使用安全性并证明其应用框架的合理性。
试验注册
ClinicalTrials.gov 标识符：NCT03453411，于 2018 年 3 月 2 日注册。
Zotero 插件