Clinical Trials Directory

Trials / Completed

CompletedNCT05435118

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Azienda Socio Sanitaria Territoriale di Lodi · Academic / Other
Sex
All
Age
2 Years – 5 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHEREMONO + audiovisuals toolEMONO + use of audiovisuals tool on smartphone or tablet

Timeline

Start date
2023-08-17
Primary completion
2024-01-31
Completion
2024-04-22
First posted
2022-06-28
Last updated
2024-04-23

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05435118. Inclusion in this directory is not an endorsement.