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

Phase 3RecruitingNCT06495372

University Hospital, Brest192 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

192

Conditions

Dental Pain and Sensation Disorder

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 15 minutes post-treatment

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)

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)

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)

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)

Time frame: 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

Time frame: Just before chairside treatment

Measuring the amount of local anesthetic used during treatment

Time frame: 1 day

Post-care satisfaction questionnaire

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

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

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)

Time frame: 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)

Time frame: 15 minutes post-treatment

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts