Study on Methoxyflurane for Pain Relief in Adult Dental Emergencies

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What is this study about?

This clinical trial is focused on managing pain in adults experiencing oral and dental emergencies. The study is investigating the effectiveness of a treatment called methoxyflurane, which is administered as an inhalation vapor. This treatment is being compared to a placebo, which looks like the treatment but does not contain the active substance. The main goal of the study is to see how well methoxyflurane can reduce pain in these emergency situations.

Participants in the study will receive either the methoxyflurane treatment or the placebo. The study will monitor the level of pain relief experienced by participants at different times after receiving the treatment. This includes checking pain levels shortly after treatment and observing how long the pain relief lasts. The study will also look at other factors, such as anxiety levels and the amount of local anesthetic used during dental procedures.

The trial is designed to be a double-blind study, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study is expected to continue until early 2026, with recruitment of participants starting in early 2024. The findings from this study could provide valuable insights into better pain management options for dental emergencies.

1 joining the study

Upon joining the study, eligibility is confirmed. This includes being an adult over 18 years old, experiencing moderate to severe pain in an oral emergency, and having social security affiliation. Informed consent is required.

2 initial assessment

Pain is assessed using a numerical pain scale (NPS) from 0 to 10. This initial measurement is crucial for evaluating the effectiveness of the treatment.

3 treatment administration

The treatment involves inhaling a liquid vapor. The active substance is methoxyflurane, administered through inhalation. A placebo may be used, which looks the same but does not contain methoxyflurane.

4 pain assessment at 15 minutes

Pain is measured again 15 minutes after treatment using the NPS. The goal is to determine if pain intensity is less than 4 out of 10.

5 additional pain assessments

Pain intensity is also measured at 7 minutes for immediate efficacy and at 40 minutes to check if the effect persists before further treatment.

6 anxiety evaluation

Anxiety levels are assessed at the start and just before any dental treatment using a modified dental anxiety scale (MDAS).

7 reporting adverse events

Any adverse events experienced during the study are documented for both the methoxyflurane and placebo groups.

8 local anesthetic measurement

The amount of local anesthetic used during dental treatment is recorded.

9 post-care satisfaction

After care, a satisfaction questionnaire is completed to gather feedback on the treatment experience.

Who Can Join the Study?

The patient must be an adult, which means they are over 18 years old.
The patient must be conscious and visiting an oral emergency department because they have pain that is considered moderate to severe. This means their pain level is rated as 4 or higher on a scale called the NPS (Numerical Pain Scale).
The patient must have social security or be a beneficiary of social security. This means they have access to government-provided health insurance or benefits.
The patient must have given informed consent, which means they have agreed to participate in the study after being fully informed about what it involves.

Who Cannot Join the Study?

Patients who are allergic to methoxyflurane or any of its ingredients cannot participate. Methoxyflurane is a type of medication used to relieve pain.
Individuals with a history of liver disease are excluded. Liver disease refers to any condition that affects the liver’s ability to function properly.
Patients who have kidney problems are not eligible. Kidney problems mean any issues that affect how the kidneys work.
People who are currently taking medications that might interact with methoxyflurane should not participate. This means if you are on certain drugs that could cause a reaction when combined with methoxyflurane, you cannot join the study.
Pregnant or breastfeeding women are excluded from the study. This is to ensure the safety of both the mother and the baby.
Children under the age of 12 cannot take part in the study.
Individuals who have participated in another clinical trial within the last 30 days are not eligible. This is to avoid any interference with the results of the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not recruiting	02.01.2024

Trial locations

Investigated drugs:

Methoxyflurane

Methoxyflurane: This medication is used to help manage pain in adults experiencing oral and dental emergencies. It is inhaled and works by providing quick pain relief. In this study, it is being evaluated to see how effective it is in reducing pain during such emergencies.

Dental Caries – Dental caries, commonly known as tooth decay, is a condition where the hard surfaces of the teeth are damaged due to the action of bacteria. These bacteria produce acids from sugar, which erode the enamel and dentin layers of the teeth. As the decay progresses, it can lead to cavities, which are small holes in the teeth. If left untreated, the decay can reach deeper layers, causing pain and potential infection. The progression of dental caries can vary, with some cases advancing rapidly while others develop slowly over time. Regular dental check-ups and good oral hygiene are essential to prevent and manage this condition.

Trial ID:

2023-508216-29-00

Protocol code:

29BRC23.0024

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Methoxyflurane for Pain Relief in Adult Dental Emergencies

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