Study on Fentanyl and Esketamine for Pain Relief in Patients with Acute Traumatic Pain

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What is this study about?

This clinical trial is focused on studying treatments for acute traumatic pain, which is a sudden and severe pain resulting from an injury. The study will compare the effectiveness of different medications in managing this type of pain. The medications being tested include fentanyl and esketamine, both of which are known for their pain-relieving properties. Fentanyl will be administered either through the nose (intranasal) or directly into the bloodstream (intravenous), while esketamine will be given either through the nose or intravenously. Additionally, a placebo may be used for comparison.

The purpose of the study is to determine if intranasal fentanyl, intravenous esketamine, and intranasal esketamine are as effective as intravenous fentanyl in providing pain relief in a prehospital setting, such as in an ambulance. Participants in the study will receive one of these treatments, and their pain levels will be monitored at various intervals, including 10 and 20 minutes after receiving the medication, as well as upon arrival at the hospital. The study will also assess the need for additional doses and any side effects experienced by participants.

This trial aims to improve pain management for individuals experiencing acute traumatic pain before they reach the hospital. By comparing these treatments, the study hopes to find the most effective and safe option for pain relief in emergency situations. The trial is expected to conclude by March 2025, with recruitment having started in September 2023.

1 joining the trial

Upon joining the trial, you will be assessed to ensure you meet the eligibility criteria. This includes being at least 18 years old, having pain caused by trauma that occurred on the same day, and requiring a strong pain reliever as determined by prehospital personnel. You will also be transported to a hospital.

2 initial assessment

Your pain level will be measured using a scale called the Numerical Rating Scale (NRS). This will help determine the effectiveness of the pain relief medication you receive.

3 medication administration

You will receive one of the following medications for pain relief: intranasal fentanyl, intravenous esketamine, or intranasal esketamine. The specific medication and its dosage will be determined by the trial protocol.

4 monitoring and follow-up

Your pain level will be reassessed 10 minutes after receiving the medication. This is to evaluate the immediate effect of the treatment.

Further assessments will occur 20 minutes after the first dose and upon arrival at the hospital. These assessments will help determine the ongoing effectiveness of the medication.

5 additional medication if needed

If your pain is not adequately managed, a second dose of the study medication may be administered. The need for additional medication will be determined by the medical team.

6 completion of trial participation

Your participation in the trial will conclude upon arrival at the hospital. Your overall satisfaction with the pain relief provided will be recorded as part of the study’s evaluation.

Who Can Join the Study?

Must be at least 18 years old.
Must have pain caused by an injury that happened on the same day.
Must need a strong painkiller, like an opioid or esketamine, as decided by emergency medical staff.
Must be on the way to a hospital for treatment.

Who Cannot Join the Study?

Patients with allergies to any of the study medications cannot participate. Allergies are when your body reacts badly to something.
Patients who are pregnant or breastfeeding cannot participate. This means if you are expecting a baby or feeding a baby with your milk.
Patients with a history of substance abuse cannot participate. Substance abuse means having problems with drugs or alcohol.
Patients with severe liver or kidney disease cannot participate. The liver and kidneys are important organs that help clean your blood and body.
Patients with uncontrolled high blood pressure cannot participate. High blood pressure is when the force of your blood against your artery walls is too high.
Patients with severe heart problems cannot participate. This includes conditions that affect how well your heart works.
Patients who have had a recent head injury cannot participate. A head injury is any harm to your head or brain.
Patients who are currently taking certain medications that might interfere with the study cannot participate. Some medicines can affect how the study drugs work.
Patients with mental health conditions that might affect their ability to understand the study cannot participate. This means if you have a condition that affects your thinking or mood.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Aaofxpsat Aptiqywne	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	11.09.2023

Trial locations

Investigated drugs:

Fentanyl is a strong pain-relief medication often used in emergency situations to help manage severe pain. In this trial, it is being tested in a form that can be sprayed into the nose, which allows it to work quickly to relieve pain. The goal is to see if this method is as effective as giving the medication through an IV, which is a more traditional way of administering it.

Esketamine is another medication being tested in this trial for its ability to relieve pain. It is being studied in two forms: one that is given through an IV and another that is sprayed into the nose. Esketamine is known for its fast-acting effects and is being compared to fentanyl to see if it can provide similar pain relief in emergency situations.

Investigated diseases:

Traumatic pain

Acute traumatic pain – Acute traumatic pain is a sudden and intense sensation of discomfort that occurs as a direct result of physical injury or trauma to the body. This type of pain typically arises immediately following an incident such as a fall, accident, or impact that causes damage to tissues, muscles, or bones. The pain is often sharp and localized to the area of injury, and it may be accompanied by swelling, bruising, or bleeding. As the body begins to heal, the intensity of the pain may decrease, but it can persist if the injury is severe or if complications arise. The progression of acute traumatic pain can vary depending on the nature and extent of the injury, as well as the individual’s response to the trauma. Over time, with proper care and healing, the pain usually diminishes and resolves.

Trial ID:

2022-500176-63-00

Protocol code:

FP-2023

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Fentanyl and Esketamine for Pain Relief in Patients with Acute Traumatic Pain

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?