Dental Pain and Sensation DisorderPhase 3METODONCT06495372
Study of the Use of Methoxyflurane vs Placebo in the Management of Pain in Oral and Dental Emergencies in Adults: METODO (METhoxyflurane in ODOntology)
A Phase 3 study of Dental Pain and Sensation Disorder, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Pain and Sensation Disorder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2024to 3 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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
- Being tested
- Experimenta group (standard of care + Methoxyflurane)., control group (standard of care + placebo).
- Medical subject headings
- Toothache, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimenta group (standard of care + Methoxyflurane).Drug
standard of care + Methoxyflurane
control group (standard of care + placebo).Drug
standard of care + placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Experimenta group (standard of care + Methoxyflurane). |
| control group | Placebo comparator | Not described Receives: Drug: control group (standard of care + placebo). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 15 minutes post-treatment
Secondary outcomes (8)
Pain intensity <4/10 (yes/no) at T=15min after treatment
Measured: 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)
Measured: 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)
Measured: 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
Measured: Just before chairside treatment
Measuring the amount of local anesthetic used during treatment
Measured: 1 day
Post-care satisfaction questionnaire
Answers to 4 questions on overall satisfaction of the care, ranging from very dissatisfied to very satisfied
Measured: 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)
Measured: 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)
Measured: 15 minutes post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start14 Oct 2024
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pain and Sensation DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495372
- Sponsor's protocol ID
- 29BRC23.0024 (METODO)
- Acronym
- METODO
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06495372
- Acronym / sponsor ID
- METODO / 29BRC23.0024 (METODO)
- Conditions
- Dental Pain and Sensation Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Experimenta group (standard of care + Methoxyflurane). |
| control group | Placebo comparator | Drug: control group (standard of care + placebo). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimenta group (standard of care + Methoxyflurane).standard of care + Methoxyflurane | Drug | Experimental group |
| control group (standard of care + placebo).standard of care + placebo | Drug | control group |
Primary outcome
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)
8 secondary outcomes
Pain intensity <4/10 (yes/no) at T=15min after treatment
Time frame: 15 minutes post-treatment
Pain assessed by a numerical rating scale at T=7min (immediate efficacy)
Time frame: 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)
Time frame: 40 minutes post-treatment
Assessment of Anxiety
Time frame: Just before chairside treatment
Measuring the amount of local anesthetic used during treatment
Time frame: 1 day
Post-care satisfaction questionnaire
Time frame: End of the study (up to 1 day)
Pain assessed by a numerical rating scale at T=15min according to analgesic associated with methoxyflurane
Time frame: 15 minutes post-treatment
Pain assessed by a numerical rating scale at T=15min according to type of emergency
Time frame: 15 minutes post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Dental Pain and Sensation Disorder, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by a numerical rating scale at baseline and at T=15min post-treatment (time frame: 15 minutes post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.