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)
- Conditions
- Dental care
- Registration Number
- 2023-508216-29-00
- Brief Summary
The main aim of this study is to evaluate the efficacy of methoxyflurane (Penthrox®) in the management of pain in oral emergencies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 192
Adult patient (> 18 years)
Conscious patient consulting an oral emergency department with pain assessed as moderate to severe NPS greater than or equal to 4
Patient has social security affiliation or who beneficiary of such social security
Patients who have given informed consent
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 & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint was pain at baseline and at T=15min post-treatment, measured using a numerical pain scale (NPS) graded from 0 to 10 The primary endpoint was pain at baseline and at T=15min post-treatment, measured using a numerical pain scale (NPS) graded from 0 to 10
- Secondary Outcome Measures
Name Time Method Pain intensity <4/10 (yes/no) at T=15min after treatment Pain intensity <4/10 (yes/no) at T=15min after treatment
Measurement of pain intensity at T=7min (immediate efficacy) Measurement of pain intensity at T=7min (immediate efficacy)
Measurement of pain intensity at T=40 minutes after treatment and just prior to treatment by the practitioner (persistence of efficacy) Measurement of pain intensity at T=40 minutes after treatment and just prior to treatment by the practitioner (persistence of efficacy)
Anxiety, measured at inclusion and just before chairside treatment using a translated and adapted anxiety questionnaire (MDAS: modified dental anxiety scale) Anxiety, measured at inclusion and just before chairside treatment using a translated and adapted anxiety questionnaire (MDAS: modified dental anxiety scale)
Report adverse events in both groups Report adverse events in both groups
Measuring the amount of local anesthetic used during treatment Measuring the amount of local anesthetic used during treatment
Post-care satisfaction questionnaire Post-care satisfaction questionnaire
Measurement of pain intensity at T=15min according to analgesic associated with methoxyflurane Measurement of pain intensity at T=15min according to analgesic associated with methoxyflurane
Measurement of pain intensity at T=15min according to type of emergency Measurement of pain intensity at T=15min according to type of emergency
Trial Locations
- Locations (1)
Centre Hospitalier Regional Et Universitaire De Brest
🇫🇷Brest, France
Centre Hospitalier Regional Et Universitaire De Brest🇫🇷Brest, FranceSylvie BOISRAMESite contact0298223330sylvie.boisrame@chu-brest.fr