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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Child, Only; Nurse's Role; Nitrous Oxide
• Intervention / Treatment: Other: EMONO + audiovisuals tool

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Lodi, Lombardia, Italy, 26900
      • Stefano Maiandi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: EMONO + audiovisuals tool; EMONO + use of audiovisuals tool on smartphone or tablet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale di Lodi
• Investigators: Principal Investigator: Stefano Maiandi, PhDs, Azienda Socio Sanitaria Territoriale di Lodi

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): April 22, 2024

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: INF202201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No