Pain, Acute Clinical Trial
— EMONOOfficial 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
Verified date | April 2024 |
Source | Azienda Socio Sanitaria Territoriale di Lodi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | April 22, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 5 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Stefano Maiandi | Lodi | Lombardia |
Lead Sponsor | Collaborator |
---|---|
Azienda Socio Sanitaria Territoriale di Lodi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | collaboration | children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016) | 30 minutes | |
Secondary | pain perception in 2 years-old children | pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997) | 30 minutes | |
Secondary | pain perception in 3 to 5 years-old children | pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988) | 30 minutes | |
Secondary | 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 | 30 minutes | |
Secondary | 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 | 30 minutes |
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