Pain, AcuteEMONONCT05435118
Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals in Children
A study testing EMONO + audiovisuals tool in people with Pain, Acute and Child, Only, run by Azienda Socio Sanitaria Territoriale di Lodi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Pain, Acute, Child, Only, Nurse's Role
- What is being tested?
- EMONO + audiovisuals tool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 17 Aug 2023to 22 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Pain, Acute, Child, Only, Nurse's Role, Nitrous Oxide
- Being tested
- EMONO + audiovisuals tool
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMONO + audiovisuals toolOther
EMONO + use of audiovisuals tool on smartphone or tablet
| Study group | Role | What they receive |
|---|---|---|
| EMONO (usual care administered to all the children undergoing painful procedures) | No intervention | 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. |
| EMONO + audiovisuals tool | Experimental | 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. Receives: Other: EMONO + audiovisuals tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
collaboration
children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016)
Measured: 30 minutes
Secondary outcomes (4)
pain perception in 2 years-old children
pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997)
Measured: 30 minutes
pain perception in 3 to 5 years-old children
pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988)
Measured: 30 minutes
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
Measured: 30 minutes
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start17 Aug 2023
- Primary completion31 Jan 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di Lodi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Maiandi, Azienda Socio Sanitaria Territoriale di Lodi
- Investigators
- Stefano Maiandi, PhDs, Principal investigator, Azienda Socio Sanitaria Territoriale di Lodi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435118
- Sponsor's protocol ID
- INF202201
- Acronym
- EMONO
- Status last verified
- Apr 2024
- First submitted
- 27 May 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maiandi S, Coluccia S, Ghizzardi G, Nicardi R, Giacchero R, Lusignani M, Gianni ML, Edefonti VC. Effectiveness of Equimolar Mixture of Oxygen and Nitrous Oxide Combined With Audiovisual in Young Children: A Randomised Controlled Trial. Eur J Pain. 2025 Sep;29(8):e70096. doi: 10.1002/ejp.70096.
PubMed 40762409Maiandi S, Ghizzardi G, Edefonti V, Giacchero R, Lusignani M, Gianni ML. Is the equimolar mixture of oxygen and nitrous oxide (EMONO) associated with audiovisuals effective in reducing pain and side effects during peripheral venous access placement in children? Protocol for a single-centre randomised controlled trial from Italy. BMJ Open. 2023 Jul 7;13(7):e067912. doi: 10.1136/bmjopen-2022-067912.
PubMed 37419632
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05435118
- Acronym / sponsor ID
- EMONO / INF202201
- Conditions
- Pain, Acute, Child, Only, Nurse's Role, Nitrous Oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di LodiUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMONO (usual care administered to all the children undergoing painful procedures) | No intervention | –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. |
| EMONO + audiovisuals tool | Experimental | Other: EMONO + audiovisuals toolUse 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. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMONO + audiovisuals toolEMONO + use of audiovisuals tool on smartphone or tablet | Other | EMONO + audiovisuals tool |
Primary outcome
collaboration
Time frame: 30 minutes
children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016)
4 secondary outcomes
pain perception in 2 years-old children
Time frame: 30 minutes
pain perception in 3 to 5 years-old children
Time frame: 30 minutes
side effect 1
Time frame: 30 minutes
side effect 2
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 40762409Maiandi S, Coluccia S, Ghizzardi G, Nicardi R, Giacchero R, Lusignani M, Gianni ML, Edefonti VC. Effectiveness of Equimolar Mixture of Oxygen and Nitrous Oxide Combined With Audiovisual in Young Children: A Randomised Controlled Trial. Eur J Pain. 2025 Sep;29(8):e70096. doi: 10.1002/ejp.70096.
- Derived from this study: PubMed 37419632Maiandi S, Ghizzardi G, Edefonti V, Giacchero R, Lusignani M, Gianni ML. Is the equimolar mixture of oxygen and nitrous oxide (EMONO) associated with audiovisuals effective in reducing pain and side effects during peripheral venous access placement in children? Protocol for a single-centre randomised controlled trial from Italy. BMJ Open. 2023 Jul 7;13(7):e067912. doi: 10.1136/bmjopen-2022-067912.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Maiandi, PhDs principal investigator
Azienda Socio Sanitaria Territoriale di Lodi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMONO + audiovisuals tool in people with Pain, Acute and Child, Only, run by Azienda Socio Sanitaria Territoriale di Lodi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collaboration (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435118, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.