Study Comparing Low-Dose Esketamine and Ketamine for Severe Acute Pain in Emergency Department Patients

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What is this study about?

This clinical trial is focused on studying treatments for severe acute pain, which is intense pain that occurs suddenly and lasts for a short period. The study will compare two medications: ketamine and esketamine. Both are used to manage pain and are administered as a solution for injection. Ketamine is given at a dose of 0.3 mg per kilogram of body weight, while esketamine is given at a dose of 0.15 mg per kilogram.

The purpose of the study is to compare the effects of these two medications on patients experiencing severe acute pain in emergency departments. Specifically, the study will look at the occurrence of any psychodysleptic effects, which are unusual mental or sensory experiences, during the first hour after treatment. Patients will be monitored for these effects every five minutes for one hour after receiving the medication.

In addition to monitoring for psychodysleptic effects, the study will also assess how well each medication relieves pain and whether additional pain relief is needed. The intensity of any unusual effects and other possible side effects will be recorded every 15 minutes during the first hour of treatment. This study aims to provide valuable information on the effectiveness and side effects of low-dose ketamine and esketamine for managing severe acute pain.

1 initial assessment

Upon joining the study, eligibility is confirmed. This includes being an adult aged 18 or over, experiencing severe acute pain, and having given informed consent.

Pain is assessed using the EN pain scale, which ranges from 0 (no pain) to 10 (maximum imaginable pain). Eligibility requires a score of 6 or higher.

2 treatment administration

Participants are randomly assigned to one of two groups: the control group receiving ketamine or the active group receiving esketamine.

The control group receives an intravenous injection of ketamine at a dose of 0.3 mg per kilogram of body weight.

The active group receives an intravenous injection of esketamine at a dose of 0.15 mg per kilogram of body weight.

3 monitoring during treatment

During the first hour of treatment, the presence of any psychodysleptic effects is assessed every 5 minutes using the SERSDA scale, which includes 9 items.

Vital signs and any other adverse effects are monitored every 15 minutes.

4 pain and effect assessment

The intensity of any psychodysleptic effects is recorded.

The effectiveness of pain relief is evaluated by tracking changes in EN pain scores and noting any additional pain relief needed.

Who Can Join the Study?

Must be an adult aged 18 or over.
Must be experiencing acute severe pain that started less than 7 days ago. The pain should be rated as 6 or higher on a scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
Must have given free and informed consent, meaning you understand the study and agree to participate.
Must be affiliated with a social security scheme, which means you are part of a system that provides health insurance or benefits.

Who Cannot Join the Study?

Patients who are not experiencing severe acute pain cannot participate. This means the study is only for those with very strong and sudden pain.
Patients who are younger than 18 years old or older than 65 years old cannot participate. The study is for adults between these ages.
Patients who are part of a vulnerable population cannot participate. This refers to groups of people who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nice	Nice	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.04.2025

Trial locations

Investigated drugs:

Esketamine is a medication being studied for its potential to manage severe acute pain in emergency settings. It is a form of ketamine that is being tested at a low dose to see if it can effectively reduce pain while minimizing side effects, particularly those related to changes in perception or mood.

Ketamine is another medication included in the study, also administered at a low dose. It is commonly used for pain relief and anesthesia. In this trial, its effects are being compared to those of esketamine to determine which is more effective and has fewer side effects, especially those affecting the mind and senses.

Severe Acute Pain – Severe acute pain is an intense and sudden sensation of discomfort that typically arises as a response to injury, surgery, or illness. It is characterized by its rapid onset and can vary in intensity from moderate to severe. This type of pain often serves as a warning signal to the body, indicating potential harm or damage. It can be localized to a specific area or more widespread, depending on the underlying cause. The pain usually diminishes as the body begins to heal, but it can be distressing and may interfere with daily activities.

Trial ID:

2024-518733-29-00

Protocol code:

24-PP-09

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Low-Dose Esketamine and Ketamine for Severe Acute Pain in Emergency Department Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?