Clinical trial 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)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dental Pain and Sensation Disorder
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain assessed by a numerical rating scale at baseline and at T=15min post-treatment
timeFrame: 15 minutes post-treatment
Secondary outcomes:
measure: Pain intensity <4/10 (yes/no) at T=15min after treatment
timeFrame: 15 minutes post-treatment
measure: Pain assessed by a numerical rating scale at T=7min (immediate efficacy)
timeFrame: 7 minutes post-treatment
measure: Pain assessed by a numerical rating scale at T=40 minutes after treatment and just prior to treatment by the practitioner (persistence of efficacy)
timeFrame: 40 minutes post-treatment
measure: Assessment of Anxiety
timeFrame: Just before chairside treatment
measure: Measuring the amount of local anesthetic used during treatment
timeFrame: 1 day
measure: Post-care satisfaction questionnaire
timeFrame: End of the study (up to 1 day)
measure: Pain assessed by a numerical rating scale at T=15min according to analgesic associated with methoxyflurane
timeFrame: 15 minutes post-treatment
measure: Pain assessed by a numerical rating scale at T=15min according to type of emergency
timeFrame: 15 minutes post-treatment
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
References: