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

• Sponsor: Azienda Socio Sanitaria Territoriale di Lodi (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05435118
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.5
• Patients Per Site Per Month: 48.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute; Child, Only; Nurse's Role; Nitrous Oxide	Other: EMONO + audiovisuals tool	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 17, 2022
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: EMONO (usual care administered to all the children undergoing painful procedures) 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.
Experimental: EMONO + audiovisuals tool 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.	Other: EMONO + audiovisuals tool; EMONO + use of audiovisuals tool on smartphone or tablet

Outcome Measures

Primary Outcome Measures

1. collaboration [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 Outcome Measures

1. pain perception in 2 years-old children [30 minutes]

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

2. pain perception in 3 to 5 years-old children [30 minutes]

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

3. side effect 1 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stefano Maiandi	Lodi	Lombardia	Italy	26900

Sponsors and Collaborators

• Azienda Socio Sanitaria Territoriale di Lodi

Investigators

• Principal Investigator: Stefano Maiandi, PhDs, Azienda Socio Sanitaria Territoriale di Lodi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefano Maiandi, MSc PhDs - Health Professionals Directorate, Azienda Socio Sanitaria Territoriale di Lodi
• ClinicalTrials.gov Identifier: NCT05435118
• Other Study ID Numbers: INF202201
• First Posted: Jun 28, 2022
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Pain

Study Results

No Results Posted as of Aug 18, 2022