Prospective double-blind randomized comparative study of the use of methoxyflurane vs placebo in the management of pain in oral and dental emergencies in adults: METODO (METhoxyflurane in ODOntology)
- Conditions
- Dental careMedDRA version: 20.0Level: HLTClassification code: 10044049Term: Dental pain and sensation disorders Class: 10017947Therapeutic area: Not possible to specify
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 192
Adult patient (> 18 years), Conscious patient consulting an oral emergency department with pain assessed as moderate to severe NPS greater than or equal to 4, Patient has social security affiliation or who beneficiary of such social security, Patients who have given informed consent
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method