Study Of the Nitrous Oxide Perception in Health Students (SONOPS)

September 17, 2019 updated by: Nantes University Hospital
In order to evaluate the perception of the Nantes health students we wish to place an anonymous survey concerning their training, their knowledge of the legislative framework governing the use of EMONO and their personal and professional experience around nitrous oxide.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The use of nitrous oxide in the form of EMONO (Equimolar Mixture of Nitrous Oxide and Oxygen) is common practice in the medical field in France since obtaining the AMM in France in 2001. It is used daily in the hospital services for its analgesic and anxiolytic properties in order to obtain a conscious sedation of the patient during the realization of painful care. Its use in liberal practice has been authorized since 2009 in France following the confirmation of its security by clinical studies.

In its medical use, the use of nitrous oxide is subject to numerous regulations; EMONO's various presentations are on the I list of poisonous substances and are subject in part to the regulation of narcotics (secure storage, obligation to report flights ...) in France. The use of this substance can only be done under medical prescription, in adapted premises, by a medical or paramedical staff specifically trained, and whose knowledge will be periodically reevaluated. All conditions of use and storage of EMONO are specified in the French Code of Public Health (Article L5123-2) and, since it is authorized in a non-hospital environment, enhanced monitoring of pharmacovigilance and addictovigilance and a Risk Management Plan (RMP) has been put in place.

Paradoxically, apart from the supervised medical use, it is very simple to obtain nitrous oxide. It is found in particular in whipped cream cartridges in a pure concentration (100% N2O) over-the-counter and unregulated. In this form it is transferred into balloons by consumers in order to be inhaled. Also known as laughing gas, it is diverted from its original use for its euphoric properties and its effects (visual and sensory distortions) that last only a few minutes.

The regulations governing the use of nitrous oxide have been put in place because the toxicity of the latter is recognized in particular during chronic use. The risks associated with the acute consumption of nitrous oxide are essentially hypoxia with even cases of death recorded in the literature. Nitrous oxide consumed chronically can inactivate vitamin B12 by oxidizing its cobalt ion causing neurological pathologies (myoneuropathies).

The risks related to nitrous oxide are certainly rare but known. The fact that it can be easily obtained gives this "legal drug" a special status combining rare but existing side effects and the risk of public abuse.

The medical and paramedical professions are the more at risk populations as the use of this molecule becomes more popular. In the literature, the death cases mainly concern dentists for exemple.

The use of nitrous oxide in the form of EMONO is not necessarily part of the core curriculum of medical and paramedical education but today requires specific training. However, all health students will one day be brought to use it in the realization of painful care. It is fundamental to respect the defined framework of this drug use so as not to end up in a situation of abuse (on the part of patients as well as that of practitioners).

There is the question of student training. Is the initial medical training on nitrous oxide sufficient? Do students have a fair perception of this medicine as well as its use and misuse? In order to evaluate the perception of the students we wish to place an anonymous questionnaire concerning their training, their knowledge of the legislative framework governing the use of MEOPA and their personal and professional experience around nitrous oxide.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • CHU de NANTES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is that of healthy students in Nantes who are exposed to the use of EMONO and their personal and professional experience with nitrous oxide.

Description

Inclusion Criteria:

  • Being an health students in Nantes University

Exclusion Criteria:

  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
nitrous oxide use in the form of EMONO
Time Frame: 5 minutes
Investigate the percentage of health students who had contact with EMONO Survey on the use of EMONO among health students
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nitrous Oxide Abuse

Clinical Trials on Nitrous oxide use

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings