Clinical trial NCT05666869: Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement
Official title: Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Acute
Keywords: analgesia
emergency department
esketamine
Lead sponsor: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


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

Primary outcomes:
measure: ESKETAMINE adverse reactions
timeFrame: From beginning of perfusion (T0) to patient exit of the emergency department (up to 4 hours after T0)
Secondary outcomes:
measure: Pain self assesment T0(a)
timeFrame: beginning of perfusion (T0)
measure: Pain self assesment T0(b)
timeFrame: beginning of perfusion (T0)
measure: Pain self assesment T15(a)
timeFrame: 15 minutes after the beginning of perfusion (T0 + 15 minutes)
measure: Pain self assesment T15(b)
timeFrame: 15 minutes after the beginning of perfusion (T0 + 15 minutes)
measure: Pain self assesment T30(a)
timeFrame: 30 minutes after the beginning of perfusion (T0 + 30 minutes)
measure: Pain self assesment T30(b)
timeFrame: 30 minutes after the beginning of perfusion (T0 + 30 minutes)
measure: Patient satisfaction about his treatment (T15)
timeFrame: 15 minutes after the beginning of perfusion (T0 + 15 minutes)
measure: Patient satisfaction about his treatment (T30)
timeFrame: 30 minutes after the beginning of perfusion (T0 + 30 minutes)
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
state: Alpes Maritimes
Study officials:
affiliation: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
name: Julie Contenti, MD, PhD
role: STUDY_DIRECTOR
References: