Dental CareMEOPAeDentNCT03453411
Effects of EMONO in Children During Dental Care
An observational study of Dental Care, run by Nantes University Hospital at 1 site in France.
Trial summary
The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The Investigators will try to characterize the children who have submitted a request to extend contact with EMONO. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Dental Care
- What is being tested?
- Non interventional study
- How many people
- 679 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2018to 24 Jun 2020
- Phase
- Observational
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: For this study we have therefore chosen to include all patients under 15 years of age seen for care under EMONO in the different participating DSCs. The use of EMONO in dental care is indicated for minor patients who are not cooperating in the dental care (doing not allow the realisation in the chair of care according to the acquired data of science) or who have a handicap limiting their cooperation. It applies during diagnostic or therapeutic consultations. The investigators will not include patients under 3 years of age as EMONO is much less effective below this age. All dental surgeons of the participating DSCs will be responsible for selecting patients who meet the inclusion criteria, offering selected patients and their parents to participate and include them in the study.
Who may be able to join
- Children aged 3 to 15, requiring care under MEOPA
Who cannot join
- Do not fit into the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre, Prospective, Uncontrolled Study to Describe the Present, Felt and Sought Effects of EMONO in Children During Dental Care
The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The Investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential.
Read the detailed description
Some narcotic drugs and psychotropic drugs associated with a risk of misuse or identified dependence and are, moreover, the object of a reinforced surveillance. This is the case of EMONO (Equimolar Oxygen and Nitrogen Protoxide Mix), which is part of the ANSM (French National Agency for Medicines and Health Products Safety) list of drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide (also called laughing gas). He has had a marketing authorization in France since 2001. Until 2009, it was reserved for hospital use. Since 2009, a modification of its MA has enabled the release of the hospital reserve, EMONO can now be used in city medicine and dental surgery. The ANSM has made its provision outside health facilities conditional on the implementation of a common national RMP, accompanied by a national monitoring of pharmacovigilance and addictovigilance. The latter is under the responsibility of CEIP-A of Nantes.
The use of EMONO in pediatric dental care is a particular mode of use in a pediatric population in which the administration of EMONO is often the first administration of a psychoactive substance known for its positive effects (euphoria). Health professionals daily observe children, who after care under EMONO, have a strong appetite for EMONO and claim for any intervention. It would be necessary to understand why, and to estimate the number of children involved. Do children feel positive effects during these actions, which could lead to a wish to prolong the contact with the gas, in search of an effect other than therapeutic? The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential.
- Conditions
- Dental Care
- Being tested
- Non interventional study
- Keywords
- Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO), Substance-Related Disorders
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
Non interventional study
| Study group | Role | What they receive |
|---|---|---|
| Non interventional study | Not described Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the effects felt and sought after by EMONO during the first care session.
Exhaustive interview of patients about the presence or absence of each expected effect of EMONO and each adverse event at the first session of care; with also questioning the perception of this effect (positive or not).
Measured: Day 0
Secondary outcomes (5)
Assess the child's appreciation of the EMONO
VAS score of contact with EMONO
Measured: Day 0
Characterization of children who experience both analgesia and anxietyolysis
Choice of the child (inhalation of EMONO) with the minting tool test (drug-liking)
Measured: Day 0
Evaluate children's palatability for EMONO and characterize children with high palatability.
Composite criterion
Measured: Day 0
Evaluate the course of taking EMONO between the first and the last session of care
Evolution of the effective dose between the first and last treatment session
Measured: Month 1
Assess the impact of the difference in practice between the French University Hospitals on anxiety
Composite criterion
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start17 May 2018
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
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 Dental CareStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Nationale de sécurité du Médicament
- Responsible party
- Sponsor
- Investigators
- Tony Prud'homme, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453411
- Sponsor's protocol ID
- RC17_0421
- Acronym
- MEOPAeDent
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2018
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prud'homme T, Rousselet M, Istvan M, Cheraud-Carpentier M, Dajean-Trutaud S, Lopez S, Muller-Bolla M, Marty M; French Pediatric Dentistry Network (FPDN); Feuillet F, Victorri-Vigneau C. Equimolar oxygen-nitrous oxide (EMONO) in dental pediatric care: which patients achieve therapeutic effects? A French national exploratory prospective observational multicenter study. Eur Arch Paediatr Dent. 2025 Feb;26(1):149-158. doi: 10.1007/s40368-024-00950-2. Epub 2024 Nov 15.
PubMed 39548019Prud'homme T, Dajean-Trutaud S, Rousselet M, Feuillet F, Carpentier-Cheraud M, Bonnot O, Hyon I, Grall-Bronnec M, Lopez-Cazaux S, Victorri-Vigneau C. The MEOPAeDent trial protocol-an observational study of the Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) effects in paediatric dentistry. BMC Oral Health. 2019 Mar 7;19(1):42. doi: 10.1186/s12903-019-0732-6.
PubMed 30845960
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Prospective, Uncontrolled Study to Describe the Present, Felt and Sought Effects of EMONO in Children During Dental Care
- ClinicalTrials.gov ID
- NCT03453411
- Acronym / sponsor ID
- MEOPAeDent / RC17_0421
- Conditions
- Dental Care
- Keywords
- Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO), Substance-Related Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Agence Nationale de sécurité du Médicament
- Study start
- 17 May 2018 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 5 Mar 2018 (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.
The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The Investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential.
Detailed description
Some narcotic drugs and psychotropic drugs associated with a risk of misuse or identified dependence and are, moreover, the object of a reinforced surveillance. This is the case of EMONO (Equimolar Oxygen and Nitrogen Protoxide Mix), which is part of the ANSM (French National Agency for Medicines and Health Products Safety) list of drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide (also called laughing gas). He has had a marketing authorization in France since 2001. Until 2009, it was reserved for hospital use. Since 2009, a modification of its MA has enabled the release of the hospital reserve, EMONO can now be used in city medicine and dental surgery. The ANSM has made its provision outside health facilities conditional on the implementation of a common national RMP, accompanied by a national monitoring of pharmacovigilance and addictovigilance. The latter is under the responsibility of CEIP-A of Nantes.
The use of EMONO in pediatric dental care is a particular mode of use in a pediatric population in which the administration of EMONO is often the first administration of a psychoactive substance known for its positive effects (euphoria). Health professionals daily observe children, who after care under EMONO, have a strong appetite for EMONO and claim for any intervention. It would be necessary to understand why, and to estimate the number of children involved. Do children feel positive effects during these actions, which could lead to a wish to prolong the contact with the gas, in search of an effect other than therapeutic? The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non interventional study | – | Other: Non interventional study |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- For this study we have therefore chosen to include all patients under 15 years of age seen for care under EMONO in the different participating DSCs. The use of EMONO in dental care is indicated for minor patients who are not cooperating in the dental care (doing not allow the realisation in the chair of care according to the acquired data of science) or who have a handicap limiting their cooperation. It applies during diagnostic or therapeutic consultations. The investigators will not include patients under 3 years of age as EMONO is much less effective below this age. All dental surgeons of the participating DSCs will be responsible for selecting patients who meet the inclusion criteria, offering selected patients and their parents to participate and include them in the study.
Key inclusion criteria (1 listed)
- Children aged 3 to 15, requiring care under MEOPA
Key exclusion criteria (1 listed)
- Do not fit into the inclusion criteria
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 |
|---|---|---|
| Non interventional studyNon interventional study | Other | Non interventional study |
Primary outcome
Description of the effects felt and sought after by EMONO during the first care session.
Time frame: Day 0
Exhaustive interview of patients about the presence or absence of each expected effect of EMONO and each adverse event at the first session of care; with also questioning the perception of this effect (positive or not).
5 secondary outcomes
Assess the child's appreciation of the EMONO
Time frame: Day 0
Characterization of children who experience both analgesia and anxietyolysis
Time frame: Day 0
Evaluate children's palatability for EMONO and characterize children with high palatability.
Time frame: Day 0
Evaluate the course of taking EMONO between the first and the last session of care
Time frame: Month 1
Assess the impact of the difference in practice between the French University Hospitals on anxiety
Time frame: Day 0
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 25 Mar 2021.
- Derived from this study: PubMed 39548019Prud'homme T, Rousselet M, Istvan M, Cheraud-Carpentier M, Dajean-Trutaud S, Lopez S, Muller-Bolla M, Marty M; French Pediatric Dentistry Network (FPDN); Feuillet F, Victorri-Vigneau C. Equimolar oxygen-nitrous oxide (EMONO) in dental pediatric care: which patients achieve therapeutic effects? A French national exploratory prospective observational multicenter study. Eur Arch Paediatr Dent. 2025 Feb;26(1):149-158. doi: 10.1007/s40368-024-00950-2. Epub 2024 Nov 15.
- Derived from this study: PubMed 30845960Prud'homme T, Dajean-Trutaud S, Rousselet M, Feuillet F, Carpentier-Cheraud M, Bonnot O, Hyon I, Grall-Bronnec M, Lopez-Cazaux S, Victorri-Vigneau C. The MEOPAeDent trial protocol-an observational study of the Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) effects in paediatric dentistry. BMC Oral Health. 2019 Mar 7;19(1):42. doi: 10.1186/s12903-019-0732-6.
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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.
Tony Prud'homme, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Care, run by Nantes University Hospital at 1 site in France.
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 1 inclusion and 1 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 25 Mar 2021. 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 France. 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?
Description of the effects felt and sought after by EMONO during the first care session. (time frame: Day 0). 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 NCT03453411, 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 25 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.