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

NCT05435118 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-23

No results posted yet for this study

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

Interventions

OTHER

EMONO + audiovisuals tool

EMONO + use of audiovisuals tool on smartphone or tablet

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale di Lodi

    lead OTHER

Principal Investigators

  • Stefano Maiandi, PhDs · Azienda Socio Sanitaria Territoriale di Lodi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2024-01-31
Completion
2024-04-22

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435118 on ClinicalTrials.gov