Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals in Children

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Acute, Child, Only, Nurse's Role, Nitrous Oxide

Intervention / Treatment
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* Other: EMONO + audiovisuals tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: EMONO (usual care administered to all the children undergoing painful procedures)<br>Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) with facial mask. In the hospital EMONO is administered to all the children for procedure pain control. | |
| Experimental: EMONO + audiovisuals tool<br>Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) with facial mask and vision of audiovisual toll with smartphone or tablet. The intervention is represented by the audiovisual tool. | Other: EMONO + audiovisuals tool<br>* EMONO + use of audiovisuals tool on smartphone or tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collaboration | children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016) | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain perception in 2 years-old children | pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997) | 30 minutes | 
| pain perception in 3 to 5 years-old children | pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988) | 30 minutes | 
| side effect 1 | vomiting during procedure Due to not available scales, numerical values from 0 (absence of sign) to 3 (presence of sign requiring medical intervention ) will be assigned to these signs | 30 minutes | 
| side effect 2 | gag reflex during procedure Due to not available scales, numerical values from 0 (absence of sign) to 3 (presence of sign requiring medical intervention ) will be assigned to these signs | 30 minutes |