Actively Recruiting

Phase 3
Age: 18Years +
All Genders
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)

Led by University Hospital, Brest · Updated on 2025-02-14

192

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient (older than 18 years)
  • Conscious patient visiting an oral emergency department with moderate to severe pain (numerical rating scale 4 or higher)
  • Patient has social security coverage or is a beneficiary
  • Patient has given informed consent
Not Eligible

You will not qualify if you...

  • Allergy to methoxyflurane or any Penthrox components, including family history of severe allergic reactions
  • History or genetic risk of malignant hyperthermia
  • Liver problems after methoxyflurane or similar anesthesia use
  • Severe kidney failure
  • Altered consciousness from any cause such as head trauma, drug, or alcohol use
  • Cardiovascular instability or respiratory depression
  • Pregnant or breastfeeding patients (pregnancy test required for women of childbearing age)
  • Patients under legal protection or deprived of liberty
  • Patients unable to speak or read French fluently or unable to understand and cooperate with pain and satisfaction assessments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Brest

Brest, France, 29200

Actively Recruiting

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Research Team

S

Sylvie BOISRAME, PU-PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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