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

Not Applicable

Completed

• Conditions: Pain, Acute; Child, Only; Nurse's Role; Nitrous Oxide
• Interventions: Other: EMONO + audiovisuals tool

• Registration Number: NCT05435118
• Lead Sponsor: Azienda Socio Sanitaria Territoriale di Lodi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-28
• Study Start: 2023-08-17
• Primary Completion: 2024-01-31
• Status Verified: 2024-04
• Study Completion: 2024-04-22
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMONO + audiovisuals tool	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.

Primary Outcome Measures

Name	Time	Method
collaboration	30 minutes	children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016)

Secondary Outcome Measures

Name	Time	Method
pain perception in 2 years-old children	30 minutes	pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997)
side effect 2	30 minutes	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
pain perception in 3 to 5 years-old children	30 minutes	pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988)
side effect 1	30 minutes	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

Trial Locations

Locations (1)

Stefano Maiandi; 🇮🇹 Lodi, Lombardia, Italy