Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-30 @ 2:14 AM
Study NCT ID:
NCT05666869
Status:
UNKNOWN
Last Update Posted:
2022-12-28
First Post:
2022-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-23', 'studyFirstSubmitDate': '2022-12-13', 'studyFirstSubmitQcDate': '2022-12-23', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ESKETAMINE adverse reactions', 'timeFrame': 'From beginning of perfusion (T0) to patient exit of the emergency department (up to 4 hours after T0)', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Pain self assesment T0(a)', 'timeFrame': 'beginning of perfusion (T0)', 'description': 'Numerical pain rating scale spanning from 0 (no pain) to 10 (the worst pain imaginable)'}, {'measure': 'Pain self assesment T0(b)', 'timeFrame': 'beginning of perfusion (T0)', 'description': '4 points Likert pain relief scale : completely relieved ; much relieved ; a little relieved ; not relieved at all'}, {'measure': 'Pain self assesment T15(a)', 'timeFrame': '15 minutes after the beginning of perfusion (T0 + 15 minutes)', 'description': 'Numerical pain rating scale spanning from 0 (no pain) to 10 (the worst pain imaginable)'}, {'measure': 'Pain self assesment T15(b)', 'timeFrame': '15 minutes after the beginning of perfusion (T0 + 15 minutes)', 'description': '4 points Likert pain relief scale : completely relieved ; much relieved ; a little relieved ; not relieved at all'}, {'measure': 'Pain self assesment T30(a)', 'timeFrame': '30 minutes after the beginning of perfusion (T0 + 30 minutes)', 'description': 'Numerical pain rating scale spanning from 0 (no pain) to 10 (the worst pain imaginable)'}, {'measure': 'Pain self assesment T30(b)', 'timeFrame': '30 minutes after the beginning of perfusion (T0 + 30 minutes)', 'description': '4 points Likert pain relief scale : completely relieved ; much relieved ; a little relieved ; not relieved at all'}, {'measure': 'Patient satisfaction about his treatment (T15)', 'timeFrame': '15 minutes after the beginning of perfusion (T0 + 15 minutes)', 'description': 'Self assessed 3 points Likert satisfaction scale : Very satisfied; Satisfied ; Not satisfied'}, {'measure': 'Patient satisfaction about his treatment (T30)', 'timeFrame': '30 minutes after the beginning of perfusion (T0 + 30 minutes)', 'description': 'Self assessed 3 points Likert satisfaction scale : Very satisfied; Satisfied ; Not satisfied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['analgesia', 'emergency department', 'esketamine'], 'conditions': ['Pain, Acute']}, 'descriptionModule': {'briefSummary': '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.\n\nNevertheless, 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.\n\nRecently, 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.\n\nStudies suggest that at equivalent doses, ESKETAMINE would be better tolerated than the KETAMINE usually used in emergency departments.\n\nIn this study, the tolerance of ESKETAMINE used at analgesic doses for treatment of moderate to severe pain will be assessed in an emergency departement\n\nA wider usage of ESKETAMINE for analgesia purpose in emergency departments is expected, with a better tolerance for the patients compared to KETAMINE'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age is 18 years old or more\n* 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)\n* Physician has decided to use ESKETAMINE\n* Patient is not opposed to enroll in the study after having been informed, as attested by the physician in the patient's file\n\nExclusion Criteria:\n\n* Adult under juridic protection, under guardianship, under curatorship\n* Patient unable to express his consent\n* Patient deprived of liberty by a judicial or administrative decision\n* Pregnant, parturient or nursing mother\n* Patients physically or mentally unable to answer the questionnaire\n* Typical kidney colic pain"}, 'identificationModule': {'nctId': 'NCT05666869', 'acronym': 'ESKETAMINE', 'briefTitle': 'Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement', 'organization': {'class': 'OTHER', 'fullName': "Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences"}, 'officialTitle': 'Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement', 'orgStudyIdInfo': {'id': 'AFERSAU-2022-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Esketamine perfusion', 'type': 'DRUG', 'description': 'Analgesic dose of ESKETAMINE via a 30 minutes.intravenous perfusion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06001', 'city': 'Nice', 'state': 'Alpes Maritimes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabien LEMOËL, MD', 'role': 'CONTACT'}, {'name': 'Shelsea THIBURCE, MD', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Universitaire de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Julie Contenti, MD, PhD', 'role': 'CONTACT', 'email': 'contenti.j@chu-nice.fr', 'phone': '0492033715', 'phoneExt': '+33'}, {'name': 'Jocelyn Rapp, MSc', 'role': 'CONTACT', 'email': 'rapp.j@chu-nice.fr', 'phone': '0492038535', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Julie Contenti, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}