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

Study Overview
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Brief Summary
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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

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

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: Esketamine perfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esketamine perfusion|Analgesic dose of ESKETAMINE via a 30 minutes.intravenous perfusion|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, emergency department, esketamine