Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05435118
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2022-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals in Children
Sponsor:
Azienda Socio Sanitaria Territoriale di Lodi
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMONO
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: