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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nice

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

29 Apr 2025 → 5 May 2026

Decision date (initial)

2025-03-06

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Compare the proportion of patients experiencing at least one psychodysleptic effect in the control and active groups during the first hour of treatment.

Secondary objectives 3

1. Assess the intensity of psychodysleptic effects described by patients
2. Compare the analgesic efficacy of the 2 molecules during the first hour of treatment: evolution of EN pain scores over time ; proportion of patients reporting relief (EN≤3/10); rate of recourse to additional analgesia (“rescue analgesia”).
3. Define the proportion of other possible adverse effects or abnormal vital constants measured every 15 minutes from t0 to t0 + 60 minutes

Conditions and MedDRA coding

Severe acute pain

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. adult patients aged 18 or over
2. 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)
3. patient has given free and informed consent
4. patient affiliated to a social security scheme

Exclusion criteria 14

1. inability to quantify pain score
2. proven or suspected intoxication (drug or alcohol intoxication) leading to consciousness disorders (Glasgow score less than or equal to 15)
3. person under legal protection or deprived of liberty
4. pregnant or breast-feeding patients
5. known allergy to ketamine or esketamine
6. history of drug addiction or dependence
7. inadequately controlled hyperthyroidism
8. history of stroke
9. severe heart failure
10. existing intracranial hypertension, glaucoma or ocular trauma
11. unstable vital signs (systolic blood pressure < 90 mmHg or > 180, heart rate < 50 per minute or > 150, respiratory rate < 10 per minute or > 30)
12. chronic treatment with aminophylline, theophylline or methylergometrine
13. administration of morphine within one hour of inclusion
14. simultaneous participation in another study that could interfere with the treatment studied or the results of the statistical analysis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients experiencing at least one psychodysleptic effect, in the control group (ketamine IV 0.3 mg/kg) and in the active group (esketamine IV 0.15 mg/kg). We used the SERSDA (Side Effects Rating Scale for Dissociate Anesthetics) scale, the most widely used in studies, with 9 items. The presence of one of these 9 items will be assessed by patients every 5 minutes from t0 (start of infusion) to t0 + 60 minutes.

Secondary endpoints 3

1. Assess the intensity of psychodysleptic effects described by patients
2. Compare the analgesic efficacy of the 2 molecules during the first hour of treatment: evolution of EN pain scores over time ; proportion of patients reporting relief (EN≤3/10); rate of recourse to additional analgesia (“rescue analgesia”).
3. Define the proportion of other possible adverse effects or abnormal vital constants measured every 15 minutes from t0 to t0 + 60 minutes.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

Sponsor organisation

Centre Hospitalier Universitaire De Nice

Address

4 Avenue Reine Victoria

City

Nice

Postcode

06000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Dr Fabien LEMOEL

Public contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Sophie BONNET

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications