Skip to main content
OpenTrials
Completed

NCT Number: NCT05435118

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Acute Acute Pain Child, Only Neurologic Manifestations Nitrous Oxide Nurse's Role Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stefano Maiandi

Lodi, Lombardy, 26900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMONO + audiovisuals tool

Other

EMONO + use of audiovisuals tool on smartphone or tablet

Primary outcomes

  1. collaboration

    Time frame: 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 outcomes

  1. pain perception in 2 years-old children

    Time frame: 30 minutes

    pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997)

  2. pain perception in 3 to 5 years-old children

    Time frame: 30 minutes

    pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988)

  3. side effect 1

    Time frame: 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

  4. side effect 2

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale di Lodi

Other

Registry information

Official study title

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

Acronym: EMONO

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2022
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.