Dental Care for ChildrenMOPEANCT03998774
Evaluation Ofe the Anxiolytic Effect of EMONO in Children During Dental Care (MOPEA)
An observational study of Dental Care for Children, run by Nantes University Hospital at 1 site in France.
Trial summary
The EquiMolar Oxygen and Nitrous Oxyde mix (EMONO) is listed by the ANSM (National Agency for the Safety of Medicines and Health Products) as drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide, presented in bottle. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Dental Care for Children
- What is being tested?
- Evaluate the anxiolytic effect during dental care with MEOPA in children
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2018to 30 Jan 2019
- How long will I take part?
- 1 Day
- 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: Children from 3 to 15 years old, requiring MEOPA treatment with local anaesthesia for the first time
Who may be able to join
- Children from 3 to 15 years,
- Requiring dental treatment under EMONO including local anesthesia
- Not opposed, as well as parents, to participate in the study
- Having a sufficiently cooperative attitude to allow the installation of the monitoring equipment
- The use of EMONO for dental care must be a first time for the child
Who cannot join
- The excluded patients will be those whose number of care is too important, justifying a general anesthesia. Similarly, patients who do not require anesthesia for their care will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uncontrolled Prospective Monocentric Study Aiming to Evaluate the Anxiolytic Effect of EMONO in Children During Dental Care
The EquiMolar Oxygen and Nitrous Oxyde mix (EMONO) is listed by the ANSM (National Agency for the Safety of Medicines and Health Products) as drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide, presented in bottle. The University Hospital of Nantes is currently conducting a general evaluation of the EMONO use in the hospital context. The department of odontology is part of this movement and wants to study the anxiolytic effect expected during dental care under MEOPA in children in the Dental Care Center. This analysis follows a previous study (MEOPAeDent) that subjectively took into account this anxiolysis.
Read the detailed description
The EquiMolar Oxygen and Nitrous Oxide Mix (EMONO) is listed by the ANSM (National Agency for the Safety of Medicines and Health Products) as drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide, presented in bottle. It has had a marketing authorization in France since 2001. Until 2009, it was reserved for hospital use and emergency vehicles; and indicated in the analgesia of short-term painful acts or during medical assistance. urgency in adults and children, dental sedation in children and frail subjects, and obstetrics. The actual benefit was considered important by the Transparency Committee.
Since 2009, a modification of the MAH for EMONO-based specialties has authorized their release from the hospital reserve, which can now be issued for professional use in city and dental surgery. Given the risks associated with the use of EMONO, in particular its potential for abuse and dependence, the ANSM conditioned its availability outside health facilities to the implementation of a common national RMP. This measure was also accompanied by a national monitoring of pharmacovigilance and addictovigilance. The latter is under the responsibility of CEIP-A of Nantes.
The University Hospital of Nantes is currently conducting a general evaluation of the use of EMONO in the hospital context. The department of odontology is part of this movement and wants to study the anxiolytic effect expected during dental care under EMONO in children in the Dental Care Center. This analysis follows a previous study (MEOPAeDent) that subjectively took into account this anxiolysis.
The analysis of this study will allow us to improve the good use of MEOPA for dental care.
- Conditions
- Dental Care for Children
- Being tested
- Evaluate the anxiolytic effect during dental care with MEOPA in children
- Keywords
- Nitrous oxide, Conscious sedation, Paediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the anxiolytic effect during dental care with MEOPA in childrenBehavioural
Primary Purpose: The main objective of this study is to evaluate the anxiolytic effect of EMONO in children during dental care.
Enrollment: 30
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the anxiolytic effect of EMONO in children during dental care
The primary endpoint will be a significant variation of heart rate at 3 key moments of the treatment session:
- Chair installation
- 5 minutes after induction of MEOPA induction
- The injection of the local anesthetic
Measured: 15 minutes
Secondary outcomes (2)
Assess whether the child's stress is less intense after certain types of dental care under EMONO by the measure of heart rate variation.
The criterion for assessing the child's stress based on the care taken will be the significant variation in heart rate at another point in the treatment session: at the time of the end of the inhalation and care. Comparison will be made between children having pulptomy or extraction.
Measured: 1 minute
Assess whether the child's stress is less intense after certain types of dental care under EMONO by the measure Veerkamp Modified VENHAM Anxiety Assessment Scale.
A Veerkamp Modified VENHAM Anxiety Assessment Scale will also be used before and after dental care ( from 0 to relaxed to 5 for extremely stressed) by the dentist. Comparison will also be made between chidren having pulpotomy or extraction.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start16 Mar 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Care for ChildrenStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tony Prud'homme, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998774
- Sponsor's protocol ID
- RC17_0275
- Acronym
- MOPEA
- Status last verified
- Sep 2021
- First submitted
- 28 May 2019
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled Prospective Monocentric Study Aiming to Evaluate the Anxiolytic Effect of EMONO in Children During Dental Care
- ClinicalTrials.gov ID
- NCT03998774
- Acronym / sponsor ID
- MOPEA / RC17_0275
- Conditions
- Dental Care for Children
- Keywords
- Nitrous oxide, Conscious sedation, Paediatric dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 26 Jun 2019 (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 EquiMolar Oxygen and Nitrous Oxyde mix (EMONO) is listed by the ANSM (National Agency for the Safety of Medicines and Health Products) as drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide, presented in bottle. The University Hospital of Nantes is currently conducting a general evaluation of the EMONO use in the hospital context. The department of odontology is part of this movement and wants to study the anxiolytic effect expected during dental care under MEOPA in children in the Dental Care Center. This analysis follows a previous study (MEOPAeDent) that subjectively took into account this anxiolysis.
Detailed description
The EquiMolar Oxygen and Nitrous Oxide Mix (EMONO) is listed by the ANSM (National Agency for the Safety of Medicines and Health Products) as drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide, presented in bottle. It has had a marketing authorization in France since 2001. Until 2009, it was reserved for hospital use and emergency vehicles; and indicated in the analgesia of short-term painful acts or during medical assistance. urgency in adults and children, dental sedation in children and frail subjects, and obstetrics. The actual benefit was considered important by the Transparency Committee.
Since 2009, a modification of the MAH for EMONO-based specialties has authorized their release from the hospital reserve, which can now be issued for professional use in city and dental surgery. Given the risks associated with the use of EMONO, in particular its potential for abuse and dependence, the ANSM conditioned its availability outside health facilities to the implementation of a common national RMP. This measure was also accompanied by a national monitoring of pharmacovigilance and addictovigilance. The latter is under the responsibility of CEIP-A of Nantes.
The University Hospital of Nantes is currently conducting a general evaluation of the use of EMONO in the hospital context. The department of odontology is part of this movement and wants to study the anxiolytic effect expected during dental care under EMONO in children in the Dental Care Center. This analysis follows a previous study (MEOPAeDent) that subjectively took into account this anxiolysis.
The analysis of this study will allow us to improve the good use of MEOPA for dental care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children from 3 to 15 years old, requiring MEOPA treatment with local anaesthesia for the first time
Key inclusion criteria (5 listed)
- Children from 3 to 15 years,
- Requiring dental treatment under EMONO including local anesthesia
- Not opposed, as well as parents, to participate in the study
- Having a sufficiently cooperative attitude to allow the installation of the monitoring equipment
- The use of EMONO for dental care must be a first time for the child
Key exclusion criteria (1 listed)
- The excluded patients will be those whose number of care is too important, justifying a general anesthesia. Similarly, patients who do not require anesthesia for their care will be excluded.
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 |
|---|---|---|
| Evaluate the anxiolytic effect during dental care with MEOPA in childrenPrimary Purpose: The main objective of this study is to evaluate the anxiolytic effect of EMONO in children during dental care. Enrollment: 30 | Behavioural | – |
Primary outcome
Evaluate the anxiolytic effect of EMONO in children during dental care
Time frame: 15 minutes
The primary endpoint will be a significant variation of heart rate at 3 key moments of the treatment session: * Chair installation * 5 minutes after induction of MEOPA induction * The injection of the local anesthetic
2 secondary outcomes
Assess whether the child's stress is less intense after certain types of dental care under EMONO by the measure of heart rate variation.
Time frame: 1 minute
Assess whether the child's stress is less intense after certain types of dental care under EMONO by the measure Veerkamp Modified VENHAM Anxiety Assessment Scale.
Time frame: 1 minute
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 13 Sep 2021.
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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 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 for Children, 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 5 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 13 Sep 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?
Evaluate the anxiolytic effect of EMONO in children during dental care (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2021.