RecruitingPHASE3INTERVENTIONAL

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

Dental emergencies, often caused by severe pain, are becoming more common in adults. Sometimes, people have to wait a while to see a dentist in an emergency. This study wants to find out if a pain relief medicine called methoxyflurane, also known as Penthrox, can quickly and effectively ease moderate to severe dental pain while people are waiting for treatment. It’s a medicine already used for other types of pain, like after an accident. Researchers will compare Penthrox with a dummy medicine (placebo) to see how well it works. The aim is to make waiting for dental care more comfortable for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Brest

Enrolment target

192

Start

14 Oct 2024

Estimated completion

01 Oct 2026

Dental Pain and Sensation Disorder

What is this study about?

Imagine you have really bad toothache and need to go to an emergency dental clinic. Sometimes, you might have to wait for a while before a dentist can see you. This can be very uncomfortable, especially when you're in a lot of pain. Doctors and nurses are always looking for better ways to help people quickly when they are in pain, especially in emergency situations.

This study, called METODO, is looking at a medicine called methoxyflurane, which you might know as Penthrox. It's a type of pain relief that’s used by emergency services for adults who have moderate to severe pain after an injury. The researchers want to see if this same medicine could be helpful for people with severe dental pain while they are waiting for treatment.

The study will involve two groups of people. One group will receive the standard care for dental pain plus methoxyflurane. The other group will receive the standard care plus a dummy medicine, called a placebo. By comparing these two groups, the researchers can find out if methoxyflurane is a safe and effective way to reduce severe dental pain quickly in an emergency setting.

Key takeaways

Targets adults with moderate to severe emergency dental pain.
Compares methoxyflurane (Penthrox) with a dummy medicine (placebo).
Aims to find a faster way to relieve dental pain during waits.
Participation involves using an inhaler and answering questions.
Strict rules on who can or cannot join based on health history.
You can leave the study at any time.

Who may be eligible?

To join this study, you need to be an adult over 18 years old and be experiencing moderate to severe dental pain that scores 4 or more on a pain scale. You also need to be able to understand and speak French well enough to answer questions and fill out forms, and be able to give your informed consent to take part.

There are certain reasons why you might not be able to join. For example, if you're allergic to methoxyflurane or if you have a history of certain serious medical conditions, such as severe kidney or liver problems, or if you've had a bad reaction to similar medicines in the past. People who are pregnant or breastfeeding, or who have serious heart or breathing problems, also cannot take part. If you have any questions about whether you can join, it's best to speak to the study team or your doctor.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or older?
Are you currently experiencing moderate to severe dental pain?
Do you have a history of serious kidney or liver problems?
Are you currently pregnant or breastfeeding?
Have you ever had a severe allergic reaction to methoxyflurane or similar medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups: either you'll receive methoxyflurane plus your usual care, or a placebo (a dummy medicine) plus your usual care. You'll be asked to describe your pain levels using a simple scale. The study team will explain how to use the medication and then monitor you carefully. There will be questions about how you feel and how satisfied you are with your pain relief. The total time you'd be involved in the study would likely be for a short period during your emergency dental visit.

Potential risks and benefits

Taking part in this study could potentially help reduce your dental pain more quickly if you receive the active medicine. However, as with any medication, there's a chance of side effects, which the study team will discuss with you. You might also receive the placebo, which means your pain relief would rely on standard treatments. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHU Brest
Verified postcode
Brest, France· Recruiting

Common questions

What is methoxyflurane (Penthrox)?

It's a fast-acting pain relief medicine, often given through an inhaler, used for moderate to severe pain, typically in emergency situations.

What is a placebo?

A placebo is a dummy medicine that looks and feels like the real treatment but doesn't contain any active drug. It helps researchers see if the real medicine is truly effective.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know until after the study is over. This helps ensure fair results.

What happens if my pain gets worse during the study?

Your safety and comfort are the top priority. The study team will be monitoring you closely and will provide additional pain relief or treatment as needed.

Do I have to pay to join the study?

No, you will not have to pay to participate in the study. All study-related treatments and assessments are provided free of charge.

How to find out more

Sylvie BOISRAME, PU-PH

sylvie.boisrame@chu-brest.fr +33 298223330 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.