Study on Pain from Propofol Injection Compared to Placebo in Healthy Adults

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What is this study about?

This clinical trial is focused on studying the pain experienced during the injection of a medication called Propofol in healthy adult participants. Propofol is commonly used as an anesthetic to help patients relax or sleep before and during surgery. The study will compare the pain caused by the injection of Propofol with that of a placebo, which is a substance with no active medication.

The purpose of the study is to determine how many participants experience significant pain when Propofol is injected intravenously, which means directly into a vein. Participants will receive either Propofol or a placebo through an intravenous bolus, which is a method of delivering a medication quickly into the bloodstream. The study will involve both male and female participants who are healthy and between the ages of 18 and 50.

Throughout the study, participants will be monitored to assess the level of pain they experience using a tool called the Visual Analog Scale (VAS), which measures pain on a scale from 0 to 100. The study will also use the Numeric Rating Scale (NRS) to measure pain on a scale from 0 to 10. The trial aims to gather information on the intensity and duration of pain following the injection, helping to better understand and manage pain associated with Propofol injections.

1 joining the study

Upon joining the study, you will be required to provide a signed informed consent. This document confirms your understanding of the study and your agreement to participate.

You must meet certain criteria, such as being between 18 and 50 years old and being in good health, as determined by a medical evaluation.

2 initial assessment

A medical professional will conduct a physical examination and review your medical history to ensure you are eligible to participate.

If you are a woman of childbearing potential, a urine pregnancy test will be conducted to confirm you are not pregnant.

3 randomization

You will be randomly assigned to receive either the study medication, propofol, or a placebo (a substance with no active medication).

This process is double-blind, meaning neither you nor the study staff will know which treatment you are receiving.

4 medication administration

The assigned medication will be administered to you as an intravenous bolus, which means it will be injected directly into your vein in a single, quick dose.

The medication used is either Propolipid 10 mg/ml or a saline solution, depending on your group assignment.

5 pain assessment

After the injection, you will be asked to rate any pain you experience using a scale called the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 100 (worst pain imaginable).

You may also be asked to use the Numeric Rating Scale (NRS), which ranges from 0 to 10, to describe your pain.

6 monitoring and follow-up

Your pain levels will be monitored over a short period, and you may be asked to describe the intensity and duration of any pain experienced.

The study will track how quickly pain reaches its maximum level and how it changes over time.

Who Can Join the Study?

The participant must be in good health, as determined by a medical check-up, which includes reviewing their medical history and a physical examination.
The participant must be 18 years or older but younger than 50 years.
If the participant is a woman who can become pregnant, a highly sensitive urine pregnancy test must show that she is not pregnant.
The participant must sign a consent form, which means they agree to follow the rules and requirements of the study.

Who Cannot Join the Study?

Participants who are not experiencing pain cannot join the study.
Participants who are younger than 18 years old cannot join the study.
Participants who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	04.08.2025

Trial locations

Investigated drugs:

Propofol is a medication used to help people relax before and during surgery or other medical procedures. It is given through an injection into a vein and works quickly to make you feel sleepy and less aware of pain. In this clinical trial, the focus is on understanding how much pain people feel when propofol is injected compared to a placebo. The goal is to see how often people experience significant pain from the injection of propofol.

Pain – Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. It can be acute, lasting for a short duration, or chronic, persisting over a longer period. Pain progresses through various stages, starting with the initial sensation, which can be sharp or dull. It may then become more intense or spread to other areas. The perception of pain can be influenced by psychological factors, making it subjective and variable among individuals. Over time, pain can lead to changes in behavior and physical function, affecting daily activities.

Trial ID:

2024-514307-34-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Pain from Propofol Injection Compared to Placebo in Healthy Adults

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?