Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Fentanyl effect on ventilatory pattern under sham postsurgical conditions – an exploratory study in healthy men and women – the FAME study

The FAME study is investigating how a widely used pain medicine, Fentanyl, affects breathing in healthy adult volunteers. Fentanyl is a powerful painkiller often used during and after surgery. This study aims to understand its effects on breathing patterns in a safe, controlled way, simulating conditions after an operation without actually performing one. The main goal is to measure the amount of carbon dioxide in the blood during the recovery phase to see how breathing is affected. Researchers will also look for any signs of breathing difficulties. The insights gained from this study could help doctors use fentanyl more safely and effectively for pain relief, ensuring patients recover well after medical procedures.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Academisch Ziekenhuis Leiden

Enrolment target

Start

15 Jan 2024

none healthy subjects

What is this study about?

This research, known as the FAME study, is all about understanding how a medicine called Fentanyl affects our breathing. Fentanyl is a strong painkiller that doctors often use, particularly when people are having surgery or recovering afterwards. Even though it's very effective for pain, it can also affect how we breathe.

In this study, healthy adults will receive Fentanyl under carefully controlled conditions. The researchers are particularly interested in how breathing returns to normal during the recovery period, after the medicine has been given. They will measure the amount of carbon dioxide in the blood, which is a good indicator of how well someone is breathing. They will also keep a close eye on other breathing changes, like how often someone breathes or if their oxygen levels drop.

The findings from the FAME study are important because they will help doctors worldwide use Fentanyl even more safely for patients. By understanding its effects on breathing better, doctors can make more informed decisions about dosing and monitoring, ultimately contributing to better and safer pain management for everyone who needs it, especially after operations.

Key takeaways

The FAME study investigates how Fentanyl, a strong painkiller, affects breathing.
It aims to make Fentanyl use safer and more effective after operations.
Healthy adults (aged 18+) are needed to take part.
Participation involves one study visit with close monitoring of breathing.
You won't have surgery, but conditions will mimic post-op recovery.
Your contribution could significantly improve patient safety and care.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome to participate. "Healthy adults" means you don't have any ongoing serious health conditions that might interfere with the study or make participation unsafe for you.

Since this study involves looking at your breathing in detail, you would need to be in good general health, especially your lungs and heart, even though this study isn't looking at them specifically. The medical team will check your health carefully to ensure it's safe for you to take part.

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 18 years old or older?
Are you generally healthy with no ongoing serious medical conditions?
Are you comfortable participating in research that involves receiving medication?
Are you able to attend a single, longer study visit?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the FAME study, you'll be involved in a single study visit. During this visit, you'll receive a controlled dose of fentanyl, and at times, another medicine called naloxone, which can help reverse the effects of fentanyl if needed.

Throughout the study, the medical team will carefully monitor your breathing. This will involve measuring your carbon dioxide levels, checking your oxygen, and observing your breathing rate. You'll have regular checks and assessments to ensure your safety and to collect the necessary information. The team will be with you throughout the process, making sure you are comfortable and safe. The total time you'd spend in the study from start to finish would be during this one extensive visit.

Potential risks and benefits

Participating in research studies like FAME can provide valuable information that helps improve healthcare for others. While you might not directly benefit from taking part, you'd be contributing to a better understanding of how pain medicines work. Like all medicines and medical procedures, there are potential risks, such as temporary changes in breathing. Every precaution will be taken to minimise these, and you'll be closely monitored by a medical team. You are always free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is Fentanyl and why is it used?

Fentanyl is a powerful pain relief medicine often used by doctors for severe pain, especially during and after operations. It works very quickly to reduce pain.

Why are you studying Fentanyl in healthy people?

By studying healthy people, researchers can understand the medicine's direct effects on the body without other health conditions making the results unclear. This helps set a baseline for safe use.

What does 'sham postsurgical conditions' mean?

It means the study will create conditions that are similar to what someone might experience after surgery, but without actually performing an operation. This helps safely reproduce the environment for testing the medicine.

Will I receive an actual operation in this study?

No, absolutely not. This study involves giving you medication and monitoring your body's response, but no surgical procedures will be performed on you.

What is Naloxone?

Naloxone is a medicine that can quickly reverse the effects of opioid painkillers like Fentanyl. It's often used in emergencies to help someone breathe normally again if they've had too much opioid medicine. It will be available and may be given if needed.