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

A

Azienda Socio Sanitaria Territoriale di Lodi

Status

Completed

Conditions

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

Treatments

Other: EMONO + audiovisuals tool

Study type

Interventional

Funder types

Other

Identifiers

NCT05435118
INF202201

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

EMONO (usual care administered to all the children undergoing painful procedures)
No Intervention group
Description:
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.
EMONO + audiovisuals tool
Experimental group
Description:
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.
Treatment:
Other: EMONO + audiovisuals tool

Trial contacts and locations

1

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Central trial contact

Stefano Maiandi, PhDs; Greta Ghizzardi, PhDs

Data sourced from clinicaltrials.gov

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