Status:
RECRUITING
Study of the Use of Methoxyflurane vs Placebo in the Management of Pain in Oral and Dental Emergencies in Adults: METODO (METhoxyflurane in ODOntology)
Lead Sponsor:
University Hospital, Brest
Conditions:
Dental Pain and Sensation Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
With a chronic shortage of dentists in some regions, and an increase in life expectancy and living conditions, the number of patients admitted to oral health emergencies is on the rise. Pain is the ma...
Eligibility Criteria
Inclusion
- Adult patient (\> 18 years)
- Conscious patient consulting an oral emergency department with pain assessed as moderate to severe NRS greater than or equal to 4
- Patient has social security affiliation or who beneficiary of such social security
- Patients who have given informed consent
Exclusion
- Patients with a history of allergy to methoxyflurane or any of the components of Penthrox (take into account family history of severe allergic reactions)
- Patients with a history of malignant hyperthermia (known or genetic predisposition)
- Patients with hepatic impairment after use of methoxyflurane or halogenated hydrocarbon anesthesia
- Patients with severe renal Failure
- Patients with altered level of consciousness, whatever the cause: head trauma, drug or alcohol abuse
- Patients with cardiovascular instability or respiratory depression
- Pregnant or breast-feeding patients. Therefore, a urine pregnancy test will be performed for all patients of childbearing age eligible to participate in the study
- Patients under legal protection (guardianship and curatorship) or deprived of liberty
- Patients unable to speak or read French fluently, unable to understand the principle of a numerical scale, anxiety and satisfaction questionnaires, and unable to cooperate with tests
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06495372
Start Date
October 14 2024
End Date
October 1 2026
Last Update
February 14 2025
Active Locations (1)
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1
CHU Brest
Brest, France, 29200