Clinical trial NCT05435118: Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals in Children
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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Child, Only
Nurse's Role
Nitrous Oxide
Lead sponsor: Azienda Socio Sanitaria Territoriale di Lodi
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: collaboration
timeFrame: 30 minutes
Secondary outcomes:
measure: pain perception in 2 years-old children
timeFrame: 30 minutes
measure: pain perception in 3 to 5 years-old children
timeFrame: 30 minutes
measure: side effect 1
timeFrame: 30 minutes
measure: side effect 2
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Lodi
country: Italy
facility: Stefano Maiandi
state: Lombardia
Study officials:
affiliation: Azienda Socio Sanitaria Territoriale di Lodi
name: Stefano Maiandi, PhDs
role: PRINCIPAL_INVESTIGATOR
References: