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NCT Number: 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)

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.

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Key information

Conditions

Dental Pain and Sensation Disorder Facial Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Brest

Brest, 29200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimenta group (standard of care + Methoxyflurane).

Drug

standard of care + Methoxyflurane

control group (standard of care + placebo).

Drug

standard of care + placebo

Primary outcomes

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

    Time frame: 15 minutes 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)

Secondary outcomes

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

    Time frame: 15 minutes post-treatment

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

    Time frame: 7 minutes post-treatment

    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)

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

    Time frame: 40 minutes post-treatment

    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)

  4. Assessment of Anxiety

    Time frame: Just before chairside treatment

    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

  5. Measuring the amount of local anesthetic used during treatment

    Time frame: 1 day

  6. Post-care satisfaction questionnaire

    Time frame: End of the study (up to 1 day)

    Answers to 4 questions on overall satisfaction of the care, ranging from very dissatisfied to very satisfied

  7. Pain assessed by a numerical rating scale at T=15min according to analgesic associated with methoxyflurane

    Time frame: 15 minutes post-treatment

    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)

  8. Pain assessed by a numerical rating scale at T=15min according to type of emergency

    Time frame: 15 minutes post-treatment

    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)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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)

Acronym: METODO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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