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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)
EU CTIS ID: 2023-508216-29-00
What this study is testing
The main aim of this study is to evaluate the efficacy of methoxyflurane (Penthrox®) in the management of pain in oral emergencies.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.