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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-17

Study Completion Date

2024-04-22

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EMONO (usual care administered to all the children undergoing painful procedures)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

EMONO + audiovisuals tool

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.

Group Type EXPERIMENTAL

EMONO + audiovisuals tool

Intervention Type OTHER

EMONO + use of audiovisuals tool on smartphone or tablet

Interventions

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EMONO + audiovisuals tool

EMONO + use of audiovisuals tool on smartphone or tablet

Intervention Type OTHER

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No