Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05666869
Status:
RECRUITING
Last Update Posted:
2022-12-28
First Post:
2022-12-13
Brief Title:
Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement
Sponsor:
Association pour la Formation lEnseignement et la Recherche du Service de lAccueil des Urgences
Organization:
Association pour la Formation lEnseignement et la Recherche du Service de lAccueil des Urgences
Study Overview
Official Title:
Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESKETAMINE
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None