NCT06495372 Study of the Use of Methoxyflurane vs Placebo in the Management of Pain in Oral and Dental Emergencies in Adults: METODO (METhoxyflurane in ODOntology)
| NCT ID | NCT06495372 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Brest |
| Condition | Dental Pain and Sensation Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 192 participants in total. It began in 2024-10-14 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 main reason for consultation, and is particularly exacerbated in the orofacial sphere. Dental pain has several etiologies: infectious, inflammatory or traumatic accidents.Beyond the ethical aspects of acute pain management, pain relief is a real objective. Despite prioritization systems, patients can wait a long time in an unsettled environment, with tired and sometimes aggressive patients. Numerous recommendations exist to improve analgesia in emergency departments, but there are still difficulties in effectively and rapidly managing acute dental and orofacial pain. To meet this demand and facilitate the treatment process, an alternative solution using methoxyflurane (Penthrox®) could be considered. This product, mainly intended for emergency services, has been approved in Europe since 2016 for the "emergency relief of moderate to severe pain associated with trauma in conscious adult patients". Thus, it would be interesting to assess the value of methoxyflurane (Penthrox®) in the management of pain in oral emergencies as a wait-and-see solution.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06495372 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dental Pain and Sensation Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06495372 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 192 participants.
Is NCT06495372 currently recruiting?
Yes, NCT06495372 is actively recruiting participants. Contact the research team at sylvie.boisrame@chu-brest.fr for enrollment information.
Where is the NCT06495372 trial being conducted?
This trial is being conducted at Brest, France.
Who is sponsoring the NCT06495372 clinical trial?
NCT06495372 is sponsored by University Hospital, Brest. The trial plans to enroll 192 participants.