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

Pain, Acute Clinical Trial

— ESKETAMINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666869
• Other study ID #: AFERSAU-2022-01
• Status: Recruiting
• Start date: December 12, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2022
• Source: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
• Contact: Julie Contenti, MD, PhD
• Phone: 0492033715
• Email: contenti.j[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: September 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies
• Pain, Acute

Intervention

Drug:
• Esketamine perfusion
Analgesic dose of ESKETAMINE via a 30 minutes.intravenous perfusion

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nice	Nice	Alpes Maritimes

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain self assesment T0(a)	Numerical pain rating scale spanning from 0 (no pain) to 10 (the worst pain imaginable)	beginning of perfusion (T0)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)