RecruitingPHASE1INTERVENTIONAL

Nebulized Fentanyl in Healthy Volunteers

This study is investigating a new, non-invasive way to give strong pain medication called fentanyl. Instead of injections, they are trying out giving it as a mist you breathe in through a face mask (nebulizer) or a spray into the nose. This is important because many people go to A&E with severe pain, and doctors want to find quicker, more comfortable ways to give pain relief without needles. The research will check how safe and comfortable these new methods are, how the body absorbs the medicine, and how effectively it works. The goal is to make pain relief faster and easier to give during emergencies, and to explore if special devices improve how the medicine is delivered.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University Hospital, Rouen

Enrolment target

Start

26 Apr 2024

Estimated completion

01 Jun 2027

Analgesia Emergencies

What is this study about?

Imagine you're really hurting and need strong pain relief quickly, but you don't want an injection. This study is looking into new ways to give a powerful pain medicine called fentanyl without needles. Currently, many people visit A&E (Accident and Emergency) because of pain, and emergency teams need fast and effective ways to help them.

The main idea is to deliver pain medicine as a fine mist through a face mask (like an inhaler, but focused on pain relief) or as a spray into the nose. The researchers want to see if these methods are safe, comfortable, and whether the medicine gets into your system properly to manage pain. They are comparing different ways the mist is made, including traditional nebulizers and newer, more advanced devices, to see which works best for delivering the medicine.

This research is important because it could lead to quicker, less stressful ways to give pain relief, especially in emergency situations. It focuses on finding methods that are kind to patients, easy for medical staff to use, and don't require injections, which can be a big step forward in how pain is managed.

Key takeaways

Exploring needle-free ways to give strong pain relief (fentanyl).
Uses a face mask (nebulizer) or nose spray.
Aims for faster, more comfortable pain relief in emergencies.
First-stage study in healthy volunteers (Phase 1).
Focuses on safety and how the medicine works in the body.
Could improve future pain management techniques.

Who may be eligible?

To join this study, you need to be a healthy adult aged between 18 and 68, and your weight should be within a healthy range (BMI between 19 and 29). You must also be able to understand the study information and give your consent.

For women, you can join if you are using very effective birth control or if you are surgically sterile (meaning you've had an operation preventing pregnancy, like a hysterectomy) or if you have gone through menopause (no periods for 12 months).

You cannot join if you weigh less than 50kg, are taking certain painkillers or other medications that could affect the study, or have long-lasting pain. Also, if you have certain ongoing health conditions like heart, kidney, liver, or breathing problems, or specific nerve conditions that affect your eye pupils, you would not be able to participate. Anyone taking medications that affect the brain or nervous system, or substances like alcohol or cannabis that might interfere with fentanyl, would also be excluded.

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 68 years old?
Is your weight (BMI) in the healthy range (19-29)?
Are you generally healthy with no long-term medical conditions?
Are you currently not taking strong painkillers or certain other medications?
For women, are you using very effective birth control, surgically sterile, or postmenopausal?

Answer every question to see your result.

What does participation involve?

This is a Phase 1 study, meaning it's an early-stage trial focusing on safety and how the drug acts in the body. You would receive the study medication, fentanyl, either as a mist you breathe in through a facial nebulizer or as a nasal spray. The researchers will then carefully measure how your body handles the medicine and check your response, using equipment like pupillometry to measure changes in your pupils. This helps them understand how well the medication is working. Exact details on the number of visits, assessments, and the total duration would be provided in the full study information, but typically Phase 1 studies involve close monitoring over a defined, shorter period.

Potential risks and benefits

Potential benefits of participating include helping advance medical understanding of new pain relief methods, which could lead to better treatment options for others in the future. As this is an early-stage study in healthy volunteers, the direct personal benefit for pain relief is not the primary goal. Potential risks associated with fentanyl include drowsiness, nausea, and changes in breathing, although you would be very closely monitored. There could also be mild discomfort from assessments. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital, Rouen
Verified postcode
Rouen, France· Recruiting

Common questions

What is fentanyl?

Fentanyl is a strong pain-relieving medicine, usually used for severe pain. This study is looking at a new way to give it.

Why use a face mask or nose spray instead of an injection?

The aim is to find easier, quicker, and more comfortable ways to give pain relief, especially in emergencies, without needing needles.

Will I feel pain during the study?

This study involves healthy volunteers and is focused on how the body handles the medicine, not on treating existing pain. You will be monitored closely.

What does 'nebulized' mean?

It means the medicine is turned into a very fine mist that you can breathe in, like using an inhaler.

Who is funding this research?

The information provided does not specify the funding source for this trial.

How to find out more

Cassandre Follet

cassandre.follet@chu-rouen.fr +33232888990 Official trial record

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