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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Pain and Sensation Disorder
• Intervention / Treatment: Drug: Experimenta group (standard of care + Methoxyflurane).; Drug: control group (standard of care + placebo).

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sylvie BOISRAME, PU-PH; Phone Number: +33 298223330; Email: sylvie.boisrame@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHU Brest
    • Contact: Sylvie BOISRAME, PUPH; Email: sylvie.boisrame@chu-brest.fr
    • Contact: Sylvie BOISRAME, PUPH
    • Contact: Arthur FALGUIERE, DDS
    • Contact: Marie ORLIAGUET, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group	Drug: control group (standard of care + placebo).; standard of care + placebo
Experimental: Experimental group	Drug: Experimenta group (standard of care + Methoxyflurane).; standard of care + Methoxyflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Pain at T=7 min post-treatment, measured using a numerical rating scale (NRS) graded from 0 to 10 (0 means no pain, 10 means maximum imaginable pain)	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)	Pain at T=40 min post-treatment, measured using a numerical rating scale (NRS) graded from 0 to 10 (0 means no pain, 10 means maximum imaginable pain)	40 minutes post-treatment
Assessment of Anxiety	Anxiety, measured at inclusion and just before chairside treatment using a translated and adapted anxiety questionnaire (MDAS: modified dental anxiety scale) Total score is a sum of all five items, range 5 to 25: 5 means not anxious, 25 means extremely anxious	Just before chairside treatment
Measuring the amount of local anesthetic used during treatment		1 day
Post-care satisfaction questionnaire	Answers to 4 questions on overall satisfaction of the care, ranging from very dissatisfied to very satisfied	End of the study (up to 1 day)
Pain assessed by a numerical rating scale at T=15min according to analgesic associated with methoxyflurane	Pain at T=15 min 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
Pain assessed by a numerical rating scale at T=15min according to type of emergency	Pain at T=15 min 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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Anesthetics, General; Anesthetics, Inhalation; Methoxyflurane
• Other Study ID Numbers: 29BRC23.0024 (METODO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No