Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Randomized controlled double-blind study ESKAPE : ESKetamine low-dose versus ketamine low-dose for Severe Acute Pain in Emergency Departments, comparison of PsychodyslEptic effects

This study, called ESKAPE, is looking at two medicines, esketamine and ketamine, both used to treat severe sudden pain in hospital emergency departments. The main goal is to compare how often patients experience unusual side effects, such as feeling strange or confused, when they receive a low dose of either medicine. Patients will be asked about these feelings every five minutes for an hour after starting the treatment. The researchers also want to see which medicine is better at reducing pain and if patients need more pain relief. They will also look for any other side effects and check vital signs like blood pressure and heart rate. It's a 'double-blind' study, meaning neither patients nor their doctors will know which medicine is being given.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire De Nice

Enrolment target

Start

06 Mar 2025

Severe acute pain

What is this study about?

Imagine you've had a sudden, very painful injury or condition and you're in the emergency department. Doctors often give strong medicines to help with this kind of pain. This particular study, called ESKAPE, is focusing on two similar medicines, ketamine and esketamine, which are part of a group of drugs that can be very effective for severe pain.

The main aim of this study is to look closely at a particular type of side effect sometimes linked to these medicines. These side effects can include feeling a bit strange, confused, or having unusual thoughts or perceptions. The researchers want to find out if one of these medicines, given at a low dose, causes these unusual feelings less often than the other, while still being good at taking away the pain. They believe that esketamine might have fewer of these side effects.

To do this, patients in the study will be given either a low dose of esketamine or a low dose of ketamine through a drip. Neither the patient nor their doctor will know which one they are receiving – this is called a 'double-blind' study and helps make the results fairer. Over the first hour, patients will be regularly asked about how their pain feels and if they're experiencing any of those unusual side effects. The researchers will also keep an eye on other things like blood pressure and heart rate, and see if patients need any extra pain relief.

Key takeaways

Compares two pain medicines for severe sudden pain.
Aims to find out if one causes fewer 'strange' side effects.
Patients asked about pain and feelings for 1 hour.
Neither patient nor doctor knows which medicine is given.
Focuses on emergency department treatment only.

Who may be eligible?

This study is open to adults aged 18 and over who are suffering from severe, sudden pain when they come into an emergency department. Both men and women can take part.

There might be other reasons why someone can't join the study, even if they fit the age and pain criteria. For example, if you have certain other health conditions, are taking specific medications, or are pregnant, you might not be suitable. The doctors involved in the study will check all these details carefully to make sure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently experiencing severe, sudden pain?
Are you currently in an emergency department?
Are you able to understand and agree to take part in the study?
Are you not pregnant or breastfeeding (if applicable)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full check-up to make sure the study is right for you. If you qualify, you would receive either a low dose of esketamine or a low dose of ketamine through a drip in your arm in the emergency department.

During the first hour of treatment, you would be asked about your pain levels and any unusual feelings or side effects you might experience, roughly every 5 minutes. Nurses would also be checking your vital signs, like your heart rate and blood pressure, every 15 minutes during this time. The study primarily focuses on this first hour of treatment and observation while you are in the emergency department. There are no long-term follow-up visits after you leave.

Potential risks and benefits

Taking part in this study might mean you receive a pain medicine (esketamine) that potentially causes fewer unusual side effects than the standard treatment (ketamine), while still relieving your pain effectively. However, it's also possible that the medicine you receive might not work as well for your pain, or you could still experience those unusual side effects. As with any medicine, there's always a risk of other, less common side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'psychodysleptic effect'?

It's a medical term for feeling strange, confused, or having unusual thoughts or perceptions, sometimes described as a 'dissociative' feeling.

Will I know which medicine I'm getting?

No, because this is a 'double-blind' study, neither you nor your doctor will know whether you're getting esketamine or ketamine.

What if my pain doesn't go away?

The team will be checking your pain regularly, and if your pain isn't controlled, you can receive additional pain relief medicine.

How long will I be in the study?

The main part of the study involves monitoring you for one hour after you receive the medicine in the emergency department.

Can I leave the study at any time?

Yes, you are always free to decide to leave the study at any point, and this won't affect your medical care.