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

NCT05435118 | Completed

• 1 other identifier: INF202201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• pain perception in 2 years-old children

  30 minutes

• pain perception in 3 to 5 years-old children

  30 minutes

• side effect 1

  30 minutes

• side effect 2

  30 minutes

Study Arms (2)

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

NO INTERVENTION

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

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

Interventions

EMONO + audiovisuals tool OTHER

EMONO + use of audiovisuals tool on smartphone or tablet

EMONO + audiovisuals tool

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale di Lodi: lead

Study Sites (1)

Stefano Maiandi

Lodi, Lombardy, 26900, Italy

Location

Related Publications (2)

• Maiandi S, Coluccia S, Ghizzardi G, Nicardi R, Giacchero R, Lusignani M, Gianni ML, Edefonti VC. Effectiveness of Equimolar Mixture of Oxygen and Nitrous Oxide Combined With Audiovisual in Young Children: A Randomised Controlled Trial. Eur J Pain. 2025 Sep;29(8):e70096. doi: 10.1002/ejp.70096.

  PMID: 40762409 DERIVED

• Maiandi S, Ghizzardi G, Edefonti V, Giacchero R, Lusignani M, Gianni ML. Is the equimolar mixture of oxygen and nitrous oxide (EMONO) associated with audiovisuals effective in reducing pain and side effects during peripheral venous access placement in children? Protocol for a single-centre randomised controlled trial from Italy. BMJ Open. 2023 Jul 7;13(7):e067912. doi: 10.1136/bmjopen-2022-067912.

  PMID: 37419632 DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Maiandi, PhDs

  Azienda Socio Sanitaria Territoriale di Lodi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc PhDs - Health Professionals Directorate

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 28, 2022
• Study Start: August 17, 2023
• Primary Completion: January 31, 2024
• Study Completion: April 22, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)