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ESKAPE randomized controlled double-blind study: ESKetamine low-dose versus ketamine low-dose for Severe Acute Pain in the Emergency Department, comparison of PsychodyslEptic effects.
EU CTIS ID: 2024-518733-29-00
What this study is testing
Compare the proportion of patients experiencing at least one psychodysleptic effect in the control and active groups during the first hour of treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- adult patients aged 18 or over
- patient consulting our department for a medical or traumatic pathology responsible for acute (less than 7 days old) and severe pain (greater than or equal to 6 on the EN pain scale, which has 11 levels: from 0 = no pain to 10 = maximum imaginable pain)
- patient has given free and informed consent
- patient affiliated to a social security scheme
You likely can't join if
- inability to quantify pain score
- existing intracranial hypertension, glaucoma or ocular trauma
- unstable vital signs (systolic blood pressure < 90 mmHg or > 180, heart rate < 50 per minute or > 150, respiratory rate < 10 per minute or > 30)
- chronic treatment with aminophylline, theophylline or methylergometrine
- administration of morphine within one hour of inclusion
- simultaneous participation in another study that could interfere with the treatment studied or the results of the statistical analysis
See the full eligibility criteria
- adult patients aged 18 or over
- patient consulting our department for a medical or traumatic pathology responsible for acute (less than 7 days old) and severe pain (greater than or equal to 6 on the EN pain scale, which has 11 levels: from 0 = no pain to 10 = maximum imaginable pain)
- patient has given free and informed consent
- patient affiliated to a social security scheme
- inability to quantify pain score
- existing intracranial hypertension, glaucoma or ocular trauma
- unstable vital signs (systolic blood pressure < 90 mmHg or > 180, heart rate < 50 per minute or > 150, respiratory rate < 10 per minute or > 30)
- chronic treatment with aminophylline, theophylline or methylergometrine
- administration of morphine within one hour of inclusion
- simultaneous participation in another study that could interfere with the treatment studied or the results of the statistical analysis
- proven or suspected intoxication (drug or alcohol intoxication) leading to consciousness disorders (Glasgow score less than or equal to 15)
- person under legal protection or deprived of liberty
- pregnant or breast-feeding patients
- known allergy to ketamine or esketamine
- history of drug addiction or dependence
- inadequately controlled hyperthyroidism
- history of stroke
- severe heart failure
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.