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

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508216-29-00

Acronym

29BRC23.0024

Enrollment

192

Registered

2024-03-18

Start date

2024-10-14

Completion date

2025-10-03

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental care

Brief summary

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

Detailed description

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=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), Report adverse events in both groups, Measuring the amount of local anesthetic used during treatment, 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 type of emergency

Interventions

DRUGPENTHROX 3mL inhalation vapour

DRUGliquid

DRUGPlacebo control corresponds to the same conditioning as the experimental treatment without methoxyflurane liquid bottle.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
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=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), Report adverse events in both groups, Measuring the amount of local anesthetic used during treatment, 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 type of emergency	—

Measure

Time frame

—

Primary

Measure	Time frame
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	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026