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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not yet recruiting
01.09.2025

Trial locations

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.

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 ID:
2025-521354-42-00
Protocol code:
PIP-Icat
Trial Phase:
Therapeutic exploratory (Phase II)

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