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

Primary Purpose

Pain, Acute, Child, Only, Nurse's Role

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EMONO + audiovisuals tool
Sponsored by
Azienda Socio Sanitaria Territoriale di Lodi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stefano MaiandiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

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

EMONO + audiovisuals tool

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

collaboration
children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016)

Secondary Outcome Measures

pain perception in 2 years-old children
pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997)
pain perception in 3 to 5 years-old children
pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988)
side effect 1
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
side effect 2
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

Full Information

First Posted
May 27, 2022
Last Updated
March 28, 2023
Sponsor
Azienda Socio Sanitaria Territoriale di Lodi
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1. Study Identification

Unique Protocol Identification Number
NCT05435118
Brief Title
Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals in Children
Acronym
EMONO
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale di Lodi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Child, Only, Nurse's Role, Nitrous Oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMONO (usual care administered to all the children undergoing painful procedures)
Arm Type
No Intervention
Arm Description
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.
Arm Title
EMONO + audiovisuals tool
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
EMONO + audiovisuals tool
Intervention Description
EMONO + use of audiovisuals tool on smartphone or tablet
Primary Outcome Measure Information:
Title
collaboration
Description
children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
pain perception in 2 years-old children
Description
pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997)
Time Frame
30 minutes
Title
pain perception in 3 to 5 years-old children
Description
pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988)
Time Frame
30 minutes
Title
side effect 1
Description
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
Time Frame
30 minutes
Title
side effect 2
Description
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
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Maiandi, PhDs
Phone
0371372739
Ext
+39
Email
stefano.maiandi@asst-lodi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Greta Ghizzardi, PhDs
Phone
0371376565
Ext
+39
Email
greta.ghizzardi@asst-lodi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Maiandi, PhDs
Organizational Affiliation
Azienda Socio Sanitaria Territoriale di Lodi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stefano Maiandi
City
Lodi
State/Province
Lombardia
ZIP/Postal Code
26900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Maiandi
Email
cardiomaio@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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