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

NCT05666869 | Unknown

• 1 other identifier: AFERSAU-2022-01
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Acute

Keywords

analgesia; emergency department; esketamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pain self assesment T0(a)

  beginning of perfusion (T0)

• Pain self assesment T0(b)

  beginning of perfusion (T0)

• Pain self assesment T15(a)

  15 minutes after the beginning of perfusion (T0 + 15 minutes)

• Pain self assesment T15(b)

  15 minutes after the beginning of perfusion (T0 + 15 minutes)

• Pain self assesment T30(a)

  30 minutes after the beginning of perfusion (T0 + 30 minutes)

Interventions

Esketamine perfusion DRUG

Analgesic dose of ESKETAMINE via a 30 minutes.intravenous perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nice

Nice, Alpes Maritimes, 06001, France

RECRUITING

MeSH Terms

Conditions

Acute Pain; Agnosia; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Julie Contenti, MD, PhD

  Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences

  STUDY DIRECTOR

Central Study Contacts

Julie Contenti, MD, PhD

CONTACT

0492033715; contenti.j@chu-nice.fr

Jocelyn Rapp, MSc

CONTACT

0492038535; rapp.j@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 28, 2022
• Study Start: December 12, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

FR (1)