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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine perfusion | Drug | Analgesic dose of ESKETAMINE via a 30 minutes.intravenous perfusion |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Contenti, MD, PhD | Contact | 0492033715 | +33 | contenti.j@chu-nice.fr |
| Jocelyn Rapp, MSc | Contact | 0492038535 | +33 | rapp.j@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julie Contenti, MD, PhD | Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Nice | Recruiting | Nice | Alpes Maritimes | 06001 | France |
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| 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) |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D000377 | Agnosia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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