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等摩尔混合氧和笑气(EMONO)联合视听是否能有效减轻儿童外周静脉穿刺置管时的疼痛和不良反应?来自意大利的单中心随机对照试验方案。

Is the equimolar mixture of oxygen and nitrous oxide (EMONO) associated with audiovisuals effective in reducing pain and side effects during peripheral venous access placement in children? Protocol for a single-centre randomised controlled trial from Italy.

机构信息

Healthcare Professions Directorate - ASST di Lodi, Lodi, Italy

Healthcare Professions Directorate - ASST di Lodi, Lodi, Italy.

出版信息

BMJ Open. 2023 Jul 7;13(7):e067912. doi: 10.1136/bmjopen-2022-067912.

Abstract

INTRODUCTION

Nurses frequently place a peripheral venous catheter during children's hospitalisation. Many studies suggest treatment of venipuncture-related pain. The administration of an equimolar mixture of oxygen and nitrous oxide (EMONO) is employed for pain control; however, no studies have analysed the association between EMONO and audiovisuals.The purpose of the study is to evaluate the effect of EMONO administration when combined with audiovisuals (EMONO+Audiovisual) versus EMONO alone on perceived pain, side effects and level of cooperation during peripheral venous access placement in children aged 2-5 years.

METHODS AND ANALYSIS

The first 120 eligible children admitted to the paediatric ward of the Lodi Hospital and presenting the indication for peripheral venous access will be enrolled. Sixty children will be randomly assigned to the experimental group (EMONO+Audiovisual) and 60 to the control group (EMONO alone).The Face, Legs, Activity, Cry, Consolability scale will be used to assess pain in the children aged 2-years old; pain in the children aged 3-5 years will be assessed using the Wong-Baker scale. The cooperation throughout the procedure will be measured using the Groningen Distress Rating Scale.

ETHICS AND DISSEMINATION

The Milan Area 1 Ethics Committee approved the study protocol (Experiment Registry No. 2020/ST/295). The trial results will be presented at conferences and published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT05435118.

摘要

简介

护士在儿童住院期间经常会放置外周静脉导管。许多研究都建议治疗与静脉穿刺相关的疼痛。目前,采用等摩尔混合氧和一氧化二氮(EMONO)来进行止痛治疗;然而,目前还没有研究分析 EMONO 与视听设备的关联。本研究旨在评估在进行外周静脉置管时,与单独使用 EMONO 相比,联合使用 EMONO 和视听设备(EMONO+视听)对 2-5 岁儿童的感知疼痛、副作用和合作程度的影响。

方法与分析

将纳入洛迪医院儿科病房中符合条件且需要进行外周静脉置管的前 120 名儿童。将 60 名儿童随机分配到实验组(EMONO+视听),60 名儿童分到对照组(单独使用 EMONO)。将使用面部、腿部、活动、哭泣、安慰评分法(FLACC)来评估 2 岁儿童的疼痛;使用 Wong-Baker 面部表情疼痛量表来评估 3-5 岁儿童的疼痛。整个过程中的合作程度将使用格罗宁根痛苦评分量表来测量。

伦理与传播

米兰第 1 区伦理委员会批准了该研究方案(实验注册号:2020/ST/295)。试验结果将在会议上展示,并发表在同行评议的期刊上。

临床试验注册号

NCT05435118。

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