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

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-14
• Study Completion Date: 2026-10-31

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.

Conditions

Dental Pain and Sensation Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Experimenta group (standard of care + Methoxyflurane).

Intervention Type: DRUG

standard of care + Methoxyflurane

control group

Group Type: PLACEBO_COMPARATOR

control group (standard of care + placebo).

Intervention Type: DRUG

standard of care + placebo

Interventions

Experimenta group (standard of care + Methoxyflurane).

standard of care + Methoxyflurane

Intervention Type: DRUG

control group (standard of care + placebo).

standard of care + placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Brest

Brest, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sylvie BOISRAME, PU-PH

Role: CONTACT

sylvie.boisrame@chu-brest.fr

+33 298223330

Facility Contacts

Sylvie BOISRAME, PUPH

Role: primary

sylvie.boisrame@chu-brest.fr

Other Identifiers

29BRC23.0024 (METODO)

Identifier Type: -

Identifier Source: org_study_id