AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind crossover study to investigate the analgesic efficacy of the bradykinin (B2) antagonist icatibant for propofol injection pain in healthy adult participants.

This research study is for healthy adult volunteers. It aims to investigate if a trial medicine called icatibant can help reduce the stinging pain people sometimes feel when they receive an injection of propofol. Propofol is a common medication given through a drip to help people feel sleepy or go to sleep for medical procedures. Volunteers will receive both the trial medicine and a dummy treatment, without knowing which they are getting at the time. Researchers will measure pain levels using a simple scale to see if icatibant makes a difference. The goal is to find a way to make common medical procedures more comfortable for patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Oslo University Hospital HF

Enrolment target

Start

14 Aug 2025

Pain

What is this study about?

When you have some medical procedures, especially those requiring you to go to sleep, doctors often use a medicine called propofol. While propofol works very well, some people find that the injection itself can cause a stinging or burning feeling. This feeling is usually brief but can be uncomfortable.

This study is looking into a new idea to make this experience better. Researchers are exploring if another medicine, called icatibant, could help prevent or reduce that stinging pain when propofol is given. Icatibant works by blocking a specific chemical in the body that can cause pain and swelling. By giving icatibant before or with the propofol, doctors hope to make the injection process more comfortable for patients.

This is an early-stage study, meaning it's one of the first times this idea is being tested in people in this way. The main goal is to carefully measure if icatibant can reduce the pain experienced during the propofol injection. If it proves to be helpful, it could lead to better ways to give common medicines and make medical experiences less stressful for many people.

Key takeaways

This study tests a new way to prevent pain from propofol injections.
Healthy adults aged 18 and over can join.
You'll receive the trial medicine and a dummy treatment at different times.
Researchers will measure your pain using a simple scale.
The goal is to make common medical procedures more comfortable.

Who may be eligible?

This study is looking for healthy adult volunteers. To take part, you need to be at least 18 years old – there's no upper age limit, as long as you're in good general health.

Both men and women are welcome to participate in this study. The most important thing is that you are generally healthy and do not have any serious ongoing medical conditions.

Before you can join, the study team will ask you some questions and do a simple check-up to make sure this study is safe and suitable for you.

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 serious ongoing medical conditions?
Are you available for several study visits?
Are you able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study centre a few times. During these visits, you'll receive an injection of propofol, which will be given along with either the trial medicine (icatibant) or a 'dummy' treatment (a saline solution, which is just salty water). You won't know which one you're getting at the time. This is done on different days, so eventually, you'll receive both the trial medicine and the dummy treatment.

After each injection, you'll be asked to rate any pain you feel using a simple scale, typically by pointing to a number or marking a line. The study team will also keep an eye on you to make sure you're feeling okay. There will be some follow-up checks to ensure everything is well after each part of the study. The total time you'll be involved in the study, including all visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it helps researchers understand if icatibant can make injections of propofol less uncomfortable, which could lead to better patient care in the future. The risks might include temporary side effects from icatibant or propofol, such as mild discomfort at the injection site or feeling drowsy from the propofol. All known risks will be fully explained to you before you agree to participate. Remember, you have the right to 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
Norway

Common questions

What is propofol?

Propofol is a common medicine given through a drip to help people feel sleepy or go to sleep for medical procedures.

What is icatibant?

Icatibant is an investigational medicine being tested to see if it can reduce the stinging pain some people feel when propofol is injected.

Will I feel sleepy during the study?

Yes, because propofol is used, you will likely feel sleepy or go to sleep briefly during parts of the study, and you won't be able to drive home afterwards.

What does 'double-blind crossover' mean?

It means neither you nor the study team will know if you're getting the trial medicine or the dummy treatment at any given time. Also, you'll receive both at different times.

Is this a new medicine?

Icatibant is an existing medicine used for other conditions, but this study is testing if it can help with propofol injection pain, which is a new use for it.