Study of the Use of Methoxyflurane vs Placebo in the Management of Pain in Oral and Dental Emergencies in Adults: METODO (METhoxyflurane in ODOntology)

NCT06495372 | Recruiting Phase 3

• 1 other identifier: 29BRC23.0024 (METODO)
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain assessed by a numerical rating scale at baseline and at T=15min post-treatment

  Pain at baseline and at T=15min post-treatment, measured using a numerical rating scale (NRS) graded from 0 to 10 (0 means no pain, 10 means maximum imaginable pain)

  15 minutes post-treatment

Secondary Outcomes (8)

• Pain intensity <4/10 (yes/no) at T=15min after treatment

  15 minutes post-treatment

• Pain assessed by a numerical rating scale at T=7min (immediate efficacy)

  7 minutes post-treatment

• Pain assessed by a numerical rating scale at T=40 minutes after treatment and just prior to treatment by the practitioner (persistence of efficacy)

  40 minutes post-treatment

• Assessment of Anxiety

  Just before chairside treatment

• Measuring the amount of local anesthetic used during treatment

  1 day

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: Experimenta group (standard of care + Methoxyflurane).

control group

PLACEBO COMPARATOR

Drug: control group (standard of care + placebo).

Interventions

Experimenta group (standard of care + Methoxyflurane). DRUG

standard of care + Methoxyflurane

Experimental group

control group (standard of care + placebo). DRUG

standard of care + placebo

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU Brest

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Toothache; Sensation Disorders

Interventions

Standard of Care; Methoxyflurane; Control Groups

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Sylvie BOISRAME, PU-PH

CONTACT

+33 298223330; sylvie.boisrame@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: July 10, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion.
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)