RecruitingPHASE4INTERVENTIONAL

3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion

This study is investigating if a special inhaled medicine called Methoxyflurane, given through a Penthrox inhaler, can help make getting an Intrauterine Device (IUD) fitted less painful and worry-free. Many people find IUD insertions quite uncomfortable, and current pain relief options often aren't enough. Methoxyflurane is a fast-acting pain reliever that you breathe in yourself. It's often used for quick pain relief in other situations. Researchers want to see if a small amount of this medicine can improve how satisfied patients are with their pain control during the procedure. The goal is to make IUD fitting a better experience, helping more people access this effective birth control method.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Women's College Hospital

Enrolment target

110

Start

27 Apr 2026

Estimated completion

01 Feb 2027

IUD

What is this study about?

Getting an Intrauterine Device, or IUD, fitted is a very common procedure that offers long-lasting contraception. However, many people find it quite painful or feel anxious during the process. The pain relief options usually offered, like common painkillers, often don't work well enough for everyone. This can make the experience difficult and sometimes puts people off getting an IUD, even if it's the best choice for them.

This study is looking into a different potential way to manage pain: an inhaled medicine called Methoxyflurane, often known by the brand name Penthrox. It's a type of pain reliever that you breathe in yourself using a small inhaler. It's known for working quickly and wearing off fast, and it's already used to help with pain in other situations like during accidents or minor medical procedures. Patients can control how much they breathe in, which helps manage their own comfort.

Researchers want to see if using a small amount of Methoxyflurane during an IUD insertion can significantly reduce pain and anxiety. The main aim is to understand if people are happier with their pain management when they use this inhaler. They will also look at how much pain and anxiety people report, and if there are any side effects. The hope is that by finding a better way to manage pain, more people will have a positive experience when getting an IUD, making it easier to access this important form of contraception.

Key takeaways

This study explores using an inhaler for pain during IUD insertion.
The inhaled medicine, Methoxyflurane, is fast-acting and self-administered.
It aims to reduce pain and anxiety for a more comfortable experience.
Participation involves using an inhaler during your IUD procedure.
The goal is to improve access to effective contraception by making IUD insertion easier.
You might receive the active drug or a comparison drug.

Who may be eligible?

To join this study, you need to be a woman between 18 and 55 years old and be planning to have an IUD fitted. You must be able to speak English and be comfortable using an inhaler device. It's also important that you are willing to have a local anaesthetic injection in your cervix (a 'cervical block') as part of your IUD insertion.

There are some reasons why you wouldn't be able to join. These include if you are pregnant, or if you've taken certain strong pain medications, cannabis, or a medicine called misoprostol in the 24 hours before your procedure. If you have a head injury, are under the influence of drugs or alcohol, or have had a bad reaction to similar medicines in the past, you also can't take part. They also can't include you if you have certain health conditions affecting your kidneys, liver, heart, or breathing, or if the shape of your womb or cervix makes the procedure very complex.

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 between 18 and 55 years old?
Are you planning to have an IUD fitted?
Are you able to understand English and use an inhaler?
Are you willing to have a local anaesthetic injection in your cervix?
Have you avoided strong pain medications or cannabis in the last 24 hours?
Do you have any serious kidney, liver, or heart problems?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have your IUD insertion as planned. Before the procedure, you'll be asked to use an inhaler: one group of patients will breathe in a small amount of the study medicine (Methoxyflurane), and another group will breathe in a substance that does not contain active medicine (called saline), as a comparison. You will breathe this in just before and during your IUD insertion to help manage pain.

Throughout the process, you will be asked questions about your pain levels and how anxious you feel. The researchers will also watch for any side effects. Your total time participating in the study will mostly be focused around the day of your IUD insertion, with a focus on your experience during and immediately after the procedure. There are no long-term follow-up visits specifically for the study, beyond your usual IUD check-ups.

Potential risks and benefits

Taking part in this study could potentially make your IUD insertion more comfortable and less painful, improving your overall experience. However, there's no guarantee that you will receive the active pain relief, as some participants will receive a comparison substance. As with any medicine, Methoxyflurane can have side effects, which are usually mild and temporary, such as feeling a bit dizzy or having a headache. Risks associated with the IUD insertion itself remain the same. You are free to withdraw from the study at any time without affecting your medical care, and your decision will be respected.

Locations (1)

Women's College Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is an IUD?

An IUD, or Intrauterine Device, is a small, T-shaped birth control device that a doctor or nurse places inside your womb to prevent pregnancy. It can be a very effective and long-lasting form of contraception.

What is Methoxyflurane?

Methoxyflurane is a medicine you breathe in through an inhaler to help quickly reduce pain. You control when and how much you breathe in, so it's often used for short, painful procedures.

Will I definitely get the pain-relieving drug?

Because this is a study, some people will get the active pain medicine and some will get a non-active substance (like plain air or saline). This helps researchers understand if the medicine really works better than no specific pain relief.

What are the common side effects?

Common side effects of Methoxyflurane are usually mild and don't last long, like feeling a little dizzy or lightheaded, or having a headache. The study will carefully monitor for any side effects.

Does taking part affect my normal IUD care?

No, joining the study will not affect the quality of your IUD insertion or your regular care. You will still receive a cervical block as planned, and you can withdraw from the study at any time without it impacting your medical treatment.

How to find out more

Didem Bozak

didem.bozak@wchospital.ca 6473814051 Official trial record

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