Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals in … (NCT05435118) | Clinical Trial Compass
CompletedNot Applicable
Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals in Children
Italy120 participantsStarted 2023-08-17
Plain-language 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.
Who can participate
Age range
2 Years – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
collaboration
Timeframe: 30 minutes
Trial details
NCT IDNCT05435118
SponsorAzienda Socio Sanitaria Territoriale di Lodi