Methoxyflurane for IUD Insertion and Endometrial Biopsy
We're researching if a special inhaler, called Penthrox, helps reduce pain during two common gynaecological procedures: inserting an Intrauterine Device (IUD) for contraception and taking a small sample from the womb lining (endometrial biopsy). These procedures can sometimes be uncomfortable, and we are looking for ways to make them easier. Participants will get either the real Penthrox inhaler or a dummy inhaler (placebo), without knowing which one, to see if the Penthrox truly makes a difference to their pain levels. We'll ask participants to rate their pain after the procedure to understand how effective the inhaler is.
At a glance
What is this study about?
Many women find procedures like getting an Intrauterine Device (IUD) fitted or having a small sample taken from the womb lining (called an endometrial biopsy) can be uncomfortable or even painful. These procedures are common and important for contraception or checking women's health. Currently, there isn't one perfect way to manage this pain for everyone, and healthcare providers are always looking for better solutions.
This study aims to discover if a particular inhaler, known as Penthrox, which contains a medicine called Methoxyflurane, can effectively reduce the pain experienced during these procedures. Penthrox is sometimes used for short-term pain relief in other medical situations. By carefully studying its effects, we hope to find a new, simple way to make these essential gynaecological procedures more comfortable for women.
To make sure our results are fair and accurate, this study is designed in a way where neither you nor your doctor will know if you are receiving the active pain relief (Penthrox) or a harmless dummy inhaler (a placebo). This helps us avoid any bias and truly understand if Penthrox works better than no treatment at all for pain relief during these specific procedures.
Key takeaways
- Tests if Penthrox inhaler reduces pain during IUD insertion or endometrial biopsy.
- Participants receive either active Penthrox or a placebo inhaler.
- Study is 'double-blind' – no one knows who gets what.
- Pain will be rated on a scale after the procedure.
- Aims to make these common procedures more comfortable.
Who may be eligible?
To join this study, you need to be a woman between 18 and 65 years old who is scheduled to have an IUD fitted or an endometrial biopsy. For IUD insertions, only women who haven't given birth before are eligible. You also need to be able to speak English.
There are a few reasons why you might not be able to take part. For instance, if you've recently taken certain strong pain medications (other than standard painkillers like paracetamol or ibuprofen) or a medicine called Misoprostol, or if you are breastfeeding. We also can't include you if you have certain existing health conditions, such as chronic pain syndromes, kidney or liver problems, or specific heart conditions.
Also, if you've had a previous unsuccessful attempt at an IUD insertion or biopsy by the same doctor, or if you have any breathing difficulties, you wouldn't be able to join. It's important that you also have someone who can drive you home after your appointment.
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 65 years old?
- Are you scheduled for an IUD insertion (and haven't given birth before) or an endometrial biopsy?
- Can you speak English?
- Do you have someone to drive you home after your appointment?
- Have you avoided strong pain relievers (other than paracetamol/ibuprofen) or Misoprostol in the last 24 hours?
- Do you have any existing chronic pain conditions, kidney/liver disease, or breathing problems? (If yes, you may not be eligible.)
What does participation involve?
If you decide to take part, you'll be assigned by chance to one of two groups: one will receive the Penthrox inhaler, and the other will receive a harmless dummy inhaler. You won't know which one you're getting. Just before your IUD insertion or endometrial biopsy, you'll be asked to inhale from the assigned device. The procedure will then be carried out as planned.
About 5 minutes after your procedure, we'll ask you to rate your pain on a special scale from 0 to 100. This is the main way we'll measure if the inhaler made a difference. Apart from using the inhaler and filling out the pain scale, there are no extra appointments or follow-up visits specifically for this study. The whole process, including the procedure and pain rating, will happen during your single appointment.
Potential risks and benefits
Locations (1)
- OPGVerified postcodeToronto, Canada· Recruiting
Common questions
What is an IUD?
An IUD, or Intrauterine Device, is a small, T-shaped birth control device that is inserted into the womb to prevent pregnancy.
What is an endometrial biopsy?
An endometrial biopsy is a procedure where a small sample of the lining of the womb (uterus) is taken. This sample can then be checked under a microscope.
What is a 'placebo'?
A placebo is a substance or treatment that has no active medicine. In this study, it's a dummy inhaler that looks and feels like the real thing, but contains no active drug, so we can compare its effects to the real medicine.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctor will know whether you are receiving the active Penthrox or the placebo. This helps to keep the study fair and accurate.
How will my pain be measured?
About 5 minutes after your procedure, you'll be asked to rate your pain on a simple scale, usually from 0 (no pain) to 100 (worst possible pain).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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