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)

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Pain and Sensation Disorder

Interventions

Type	Name	Description
DRUG	Experimenta group (standard of care + Methoxyflurane).	standard of care + Methoxyflurane
DRUG	control group (standard of care + placebo).	standard of care + placebo

Timeline

• Start date: 2024-10-14
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-07-10
• Last updated: 2025-02-14

Locations

1 site across 1 country: France