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CompletedNCT04095494SONOPSUpdated Sep 19, 2019

Study Of the Nitrous Oxide Perception in Health Students

An observational study in Nitrous Oxide Abuse, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-19.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Nitrous Oxide Abuse

Keywords

  • EMONO
  • Health students
03

In context

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Being an health students in Nantes University

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
250 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • BehavioralNitrous oxide use

    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.

06

What researchers measure

Primary outcomes

  1. nitrous oxide use in the form of EMONO

    Investigate the percentage of health students who had contact with EMONO Survey on the use of EMONO among health students

    Time frame: 5 minutes

07

Study locations

1 site
  • Chu de Nantes
    Nantes, 44093, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04095494
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Sep 19, 2019
Start date
May 1, 2019
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019
Last update
Sep 19, 2019

Study contacts

Tony Prud'homme
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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