Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals During Peripheral Venous Access Insertion of Children Between 2-5 Years Old Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- collaboration
研究概览
简要总结
Children experience numerous painful experiences from nursing procedures: peripheral venous access placement is the main cause of procedural pain.
As much as pharmacological and nonpharmacological tools are known, their application during venipuncture is not systematic by children's hospitals.
Among pharmacological tools, the Equimolar Mixture of Nitrogen Protoxide and Oxygen (EMONO) provides adequate protection from procedural pain through inhalation of the gas mixture at least 3 minutes before the procedure.
Literature reports that the combination of nonpharmacological distractive tools and pharmacological interventions increases their analgesic effect.
The aim of the study is to measure children's cooperation during procedure (primary outcome), pain perception and side effects when EMONO is combined with audiovisuals compared with EMONO alone in peripheral venous access placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 years and 5 years and 364 days
- •Prescription for peripheral venous access placement
- •Parental consent for participation in the study
- •Presence of at least one parent in possession of a smartphone/tablet with the ability to connect to the Internet through Wi-Fi available to users
- •Absence of contraindications to the administration of EMONO reported in health records
- •Absence of facial pathology
- •Presence on duty of at least one experimental nurse trained in the use of EMONO
排除标准
- •Age less than 2 years and more than 5 years and 364 days
- •No parental consent to participate in the study
- •Parents not in possession of a smartphone/tablet with the ability to connect to the internet through Wi-Fi available to users
- •Presence of contraindications to EMONO administration
- •Presence of facial pathology
- •Oxygen therapy
- •Presence of tracheostomy
- •Absence on duty of at least one experimental nurse trained in the use of EMONO
结局指标
主要结局
collaboration
时间窗: 30 minutes
children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016)
次要结局
- pain perception in 2 years-old children(30 minutes)
- side effect 2(30 minutes)
- pain perception in 3 to 5 years-old children(30 minutes)
- side effect 1(30 minutes)
研究者
Stefano Maiandi
MSc PhDs - Health Professionals Directorate
Azienda Socio Sanitaria Territoriale di Lodi