Using Methoxyflurane for Pain Management in Dental Emergencies
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)
This study is testing if a pain relief medication called methoxyflurane can help adults with moderate to severe dental pain feel better during emergencies compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Trial ID | NCT06495372 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of methoxyflurane, a pain relief medication, compared to a placebo in managing moderate to severe dental pain in adults seeking emergency care. The study aims to address the growing demand for effective pain management in oral health emergencies, particularly in regions with a shortage of dental professionals. Participants will receive either standard care combined with methoxyflurane or standard care with a placebo, allowing researchers to assess the drug's efficacy in alleviating pain. The trial is conducted at the University Hospital in Brest, focusing on patients who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old experiencing moderate to severe dental pain.
Not a fit: Patients with a history of severe allergic reactions to methoxyflurane or those with significant health issues such as severe renal failure or cardiovascular instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective option for managing acute dental pain in emergency settings.
How similar studies have performed: Previous studies have shown promising results with methoxyflurane in emergency pain management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brest
- CHU Brest — Brest, France (Recruiting)
Study contacts
- Study coordinator: Sylvie BOISRAME, PU-PH
- Email: sylvie.boisrame@chu-brest.fr
- Phone: +33 298223330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.