Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drugNo placebo
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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

3 criteria

  • 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.
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 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

  • 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.

What is already known about the treatment

  • Esketamine

    Esketamine is administered as a nasal spray and is currently being studied for its effectiveness in treating severe acute pain, particularly in emergency department settings. It is a derivative of ketamine and is known for its rapid action in pain relief. The medication works by blocking NMDA receptors in the brain, which are involved in pain transmission and perception. Esketamine is classified as a dissociative anesthetic and is being compared to ketamine in clinical trials to assess its psychodysleptic effects, which are changes in perception and mood.

  • Ketamine

    Ketamine is typically administered intravenously or intramuscularly and is well-established in medical literature for its use in anesthesia and pain management. It is being studied for its role in managing severe acute pain in emergency settings. Ketamine acts by blocking NMDA receptors, which helps in reducing pain and altering perception. It is classified as a dissociative anesthetic and is being compared to esketamine in clinical trials to evaluate the incidence of psychodysleptic effects, which include altered sensory experiences and mood changes.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518733-29-00Protocol code24-PP-09Estimated enrolment74 patientsSponsorCentre Hospitalier Universitaire De Nice

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.