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

NCT ID: NCT05666869

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2023-09-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Esketamine perfusion

Analgesic dose of ESKETAMINE via a 30 minutes.intravenous perfusion

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Contenti, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

Centre Hospitalier Universitaire de Nice

Nice, Alpes Maritimes, France

Site Status: RECRUITING

Countries

France

Central Contacts

Julie Contenti, MD, PhD

Role: CONTACT

contenti.j@chu-nice.fr

0492033715 ext. +33

Jocelyn Rapp, MSc

Role: CONTACT

rapp.j@chu-nice.fr

0492038535 ext. +33

Facility Contacts

Fabien LEMOËL, MD

Role: primary

Shelsea THIBURCE, MD

Role: backup

Other Identifiers

AFERSAU-2022-01

Identifier Type: -

Identifier Source: org_study_id