Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement (ESKETAMINE)

KETAMINE has been used for several years in emergency departments for analgesic purposes. Its ease of use and its analgesic effect have been demonstrated in several studies.

Nevertheless, this molecule is not devoid of side effects, in particular the very frequent occurrence of nausea, vomiting, anxiety, an overall feeling of discomfort and more rarely hallucinations, feelings of unreality, or tachycardia.

Recently, ESKETAMINE, used as an anesthetic but also in the USA as an antidepressant, has obtained its Marketing Authorization in the management of moderate to severe pain. ESKETAMINE corresponds to the S-(-)-KETAMINE enantiomer. Like KETAMINE, it acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor but unlike KETAMINE does not interact, with the sigma receptors responsible for hallucinations and delusional symptoms. ESKETAMINE aimed at anesthetic is about twice as potent as KETAMINE and would also be eliminated more quickly.

Studies suggest that at equivalent doses, ESKETAMINE would be better tolerated than the KETAMINE usually used in emergency departments.

In this study, the tolerance of ESKETAMINE used at analgesic doses for treatment of moderate to severe pain will be assessed in an emergency departement

A wider usage of ESKETAMINE for analgesia purpose in emergency departments is expected, with a better tolerance for the patients compared to KETAMINE

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute
• Intervention / Treatment: Drug: Esketamine perfusion

• Study Type: Observational
• Enrollment (Anticipated): 55

Contacts and Locations

• Study Contact: Name: Julie Contenti, MD, PhD; Phone Number: +33 0492033715; Email: contenti.j@chu-nice.fr
• Study Contact Backup: Name: Jocelyn Rapp, MSc; Phone Number: +33 0492038535; Email: rapp.j@chu-nice.fr

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06001
      • Recruiting
      • Centre Hospitalier Universitaire de Nice
      • Contact: Fabien LEMOËL, MD
      • Contact: Shelsea THIBURCE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the emergency department of the university hospital of Nice, France (Hôpital Pasteur 2) from monday to friday, 8h30 am to 6h30 pm, meeting the eligibility criteria

Description

Inclusion Criteria:

• Age is 18 years old or more
• Moderate to severe pain as assessed by the patient with a verbal numerical rating scale (NRS) of 6/10 or more ; NRS goes from 0 (no pain) to 10 (the worst pain imaginable)
• Physician has decided to use ESKETAMINE
• Patient is not opposed to enroll in the study after having been informed, as attested by the physician in the patient's file

Exclusion Criteria:

• Adult under juridic protection, under guardianship, under curatorship
• Patient unable to express his consent
• Patient deprived of liberty by a judicial or administrative decision
• Pregnant, parturient or nursing mother
• Patients physically or mentally unable to answer the questionnaire
• Typical kidney colic pain

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ESKETAMINE adverse reactions	Enumeration of the adverse reactions occuring to the patient as collected by the investigator in the patient file and by the patient in the study questionnaire	From beginning of perfusion (T0) to patient exit of the emergency department (up to 4 hours after T0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain self assesment T0(a)	Numerical pain rating scale spanning from 0 (no pain) to 10 (the worst pain imaginable)	beginning of perfusion (T0)
Pain self assesment T0(b)	4 points Likert pain relief scale : completely relieved ; much relieved ; a little relieved ; not relieved at all	beginning of perfusion (T0)
Pain self assesment T15(a)	Numerical pain rating scale spanning from 0 (no pain) to 10 (the worst pain imaginable)	15 minutes after the beginning of perfusion (T0 + 15 minutes)
Pain self assesment T15(b)	4 points Likert pain relief scale : completely relieved ; much relieved ; a little relieved ; not relieved at all	15 minutes after the beginning of perfusion (T0 + 15 minutes)
Pain self assesment T30(a)	Numerical pain rating scale spanning from 0 (no pain) to 10 (the worst pain imaginable)	30 minutes after the beginning of perfusion (T0 + 30 minutes)
Pain self assesment T30(b)	4 points Likert pain relief scale : completely relieved ; much relieved ; a little relieved ; not relieved at all	30 minutes after the beginning of perfusion (T0 + 30 minutes)
Patient satisfaction about his treatment (T15)	Self assessed 3 points Likert satisfaction scale : Very satisfied; Satisfied ; Not satisfied	15 minutes after the beginning of perfusion (T0 + 15 minutes)
Patient satisfaction about his treatment (T30)	Self assessed 3 points Likert satisfaction scale : Very satisfied; Satisfied ; Not satisfied	30 minutes after the beginning of perfusion (T0 + 30 minutes)

Collaborators and Investigators

• Sponsor: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
• Investigators: Study Director: Julie Contenti, MD, PhD, Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: esketamine; emergency department; analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Acute Pain; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: AFERSAU-2022-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No