Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Evaluating the effectiveness of icatibant in reducing propofol injection pain in healthy adult volunteers

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on managing injection pain that occurs when patients receive propofol, a medication used for anesthesia. The study aims to test whether a medication called icatibant can help reduce the discomfort that people experience during propofol administration.

The research involves testing two different treatments: icatibant and a placebo. Both treatments will be given through intravenous injection, which means they are delivered directly into a vein. The study uses propofol in the form of an injection/infusion solution called Propolipid, along with a salt solution to dilute the medications.

During the study, participants will receive both treatments at different times, and their pain levels will be measured using a special scale. The total duration of treatment for each participant is expected to be very short, lasting only a few days. This is a carefully controlled study where neither the participants nor the healthcare providers know which treatment is being given at any particular time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    A medical evaluation will be performed, including medical history and physical examination to confirm your health status

    If you are a woman who can become pregnant, you will need to take a urine pregnancy test

  2. Step 2

    Pain sensitivity assessment

    You will receive a propofol injection to assess your pain sensitivity

    Your pain level will be measured using a pain scale from 0 to 100

    To qualify for the next phase, you must experience a pain level of at least 30 on the scale

  3. Step 3

    Treatment phase

    You will receive two different treatments on separate occasions:

    One treatment will include icatibant (a pain-reducing medication)

    The other treatment will include a placebo (inactive substance)

    Neither you nor the medical staff will know which treatment you are receiving at the time

    Both medications will be given through an intravenous injection (directly into a vein)

  4. Step 4

    Pain evaluation

    After each treatment, your pain levels will be measured using the same pain scale (0-100)

    The medical team will record how the pain changes over time

    The maximum pain level will be documented for each treatment session

  5. Step 5

    Study completion

    The study will continue until all treatment sessions are completed

    A final medical evaluation will be performed to ensure your well-being

Who can join the trial?

5 criteria

  • You must be considered healthy based on a medical evaluation, which includes reviewing your medical history and having a physical examination
  • Your age must be between 18 and 50 years
  • If you are a woman who can become pregnant (WOCBP), you must have a negative urine pregnancy test
  • You must read, understand, and sign an informed consent form agreeing to follow all study requirements and restrictions
  • You must have previously participated in the PropPain study and experienced pain measuring at least 30 millimeters on a visual pain scale (VAS - a tool where you mark your pain level on a line from no pain to worst pain)

Who cannot join the trial?

14 criteria

  • History of allergic reactions or hypersensitivity to propofol (an anesthetic medication) or its components
  • History of allergic reactions to icatibant (the study medication)
  • Pregnant or breastfeeding women
  • Current use of pain medications or medications that could interact with the study drugs
  • Any significant medical conditions that could affect pain perception
  • History of chronic pain conditions
  • Current participation in other clinical trials
  • Unable to follow study instructions or provide informed consent
  • History of drug or alcohol abuse within the past year
  • Any abnormal blood test results that could indicate health issues
  • Severe kidney or liver problems
  • Uncontrolled high blood pressure or heart conditions
  • History of blood clotting disorders
  • Mental health conditions that could affect pain assessment
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Icatibant

    is a medication that works by blocking a substance in the body called bradykinin. It is being studied to see if it can help reduce pain that occurs when patients receive propofol injections. The medication is typically given as an injection under the skin.

  • Propofol

    is an anesthetic medication given through an intravenous (IV) line that helps put patients to sleep before surgery. While effective as an anesthetic, it is known to cause pain or discomfort at the injection site when administered.

What is already known about the treatment

  • Icatibant

    A synthetic peptide medication administered through subcutaneous injection that works by blocking bradykinin B2 receptors, which are involved in pain and inflammation processes. It is primarily used in the treatment of acute attacks of hereditary angioedema, and is being studied for its potential in reducing injection-related pain. The medication belongs to the class of selective bradykinin B2 receptor antagonists and works by preventing bradykinin from binding to its receptors, thereby reducing pain signaling and inflammatory responses.

  • Propofol

    A short-acting intravenous anesthetic agent commonly used for the induction and maintenance of general anesthesia, as well as for sedation in intensive care settings. This white, oil-based emulsion is known to cause injection site pain in many patients during administration. It works by enhancing the effects of GABA, the main inhibitory neurotransmitter in the brain, and belongs to the class of alkylphenols, providing rapid onset of action and quick recovery time.

Investigated diseases

  • Acute Pain

    A sudden onset of unpleasant sensory experience triggered by actual or potential tissue damage. It serves as a warning mechanism that helps protect the body from harm. Acute pain typically develops quickly and can range from mild to severe intensity. The sensation can be sharp, throbbing, or burning in nature. It usually subsides as the underlying cause heals.

  • Propofol Injection Pain

    A specific type of acute pain that occurs during the administration of the anesthetic drug propofol through intravenous injection. It manifests as a burning or stinging sensation at the injection site, typically in the arm where the medication is being administered. The discomfort usually begins immediately upon injection and can vary in intensity from mild to severe. The sensation is temporary and typically resolves shortly after the injection is complete.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521354-42-00Protocol codePIP-IcatEstimated enrolment26 patientsSponsorOslo University Hospital HF

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.