Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT03236805
Status:
TERMINATED
Last Update Posted:
2022-12-21
First Post:
2017-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'whyStopped': "285 patients have recruited instead on 496 but we don't want to continue to prolonge the study. Analysis will be performed on the data we have.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-28', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection.', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 15 minutes post first injection.', 'timeFrame': '15 minutes'}, {'measure': 'Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 45 minutes post first injection.', 'timeFrame': '45 minutes'}, {'measure': 'Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 60 minutes post first injection.', 'timeFrame': '60 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Morphine', 'Ketamine', 'Acute pain', 'prehospital'], 'conditions': ['Pain Management']}, 'referencesModule': {'references': [{'pmid': '38285446', 'type': 'DERIVED', 'citation': 'Le Cornec C, Le Pottier M, Broch H, Marguinaud Tixier A, Rousseau E, Laribi S, Janiere C, Brenckmann V, Guillerm A, Deciron F, Kabbaj A, Jenvrin J, Pere M, Montassier E. Ketamine Compared With Morphine for Out-of-Hospital Analgesia for Patients With Traumatic Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352844. doi: 10.1001/jamanetworkopen.2023.52844.'}, {'pmid': '29716637', 'type': 'DERIVED', 'citation': 'Le Cornec C, Lariby S, Brenckmann V, Hardouin JB, Ecoffey C, Le Pottier M, Fradin P, Broch H, Kabbaj A, Auffret Y, Deciron F, Longo C, Javaudin F, Le Bastard Q, Jenvrin J, Montassier E. Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial. Trials. 2018 May 2;19(1):260. doi: 10.1186/s13063-018-2634-3.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, single-blind trial evaluating prehospital patients experiencing moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5. Patients will be randomized to receive ketamine at or morphine by intravenous push.', 'detailedDescription': 'This study is designed to evaluate if ketamine alone is non inferior to morphine alone for prehospital analgesia. Numeric rating scale pain scores will be compared between recipients of ketamine and recipients of morphine at 15, 30, 45 and 60 min post first injection and at hospital admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years old\n* prehospital moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5\n\nExclusion Criteria:\n\n* unstable vital signs (systolic blood pressure \\<90 or \\>200 mm Hg, pulse rate \\<50 or \\>150 beats/min, and respiration rate \\<10 or \\>30 breaths/min)\n* pregnancy\n* breast-feeding\n* altered mental status\n* unable to give numeric rating scale scores\n* allergy to morphine or ketamine\n* acute pulmonary edema\n* acute coronary syndrome\n* renal or hepatic insufficiency\n* patient who received morphine for the same acute pain\n* acute psychiatric illness'}, 'identificationModule': {'nctId': 'NCT03236805', 'acronym': 'KETAMORPH', 'briefTitle': 'Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RC17_0082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine IV', 'interventionNames': ['Drug: Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine IV', 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'Initial bolus of 20 mg (around 0.3 mg per kg) followed by bolus of 10 mg every 5 minutes as reported by the recommandations of experts of the french society of urgency care', 'armGroupLabels': ['Ketamine IV']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'Bolus of 2 mg (patient with weight under 60 kgs) or bolus of 3 mg (patient with weight above 60 kgs) every 5 minutes as reported by the recommandations of experts of the french society of urgency care', 'armGroupLabels': ['Morphine IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'University Hospital of Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '44146', 'city': 'Châteaubriant', 'country': 'France', 'facility': 'Hospital of Chateaubriant', 'geoPoint': {'lat': 47.71675, 'lon': -1.37643}}, {'zip': '95500', 'city': 'Gonesse', 'country': 'France', 'facility': 'CH de Gonesse', 'geoPoint': {'lat': 48.98693, 'lon': 2.44892}}, {'zip': '38700', 'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '85600', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'La Roche sur Yon Hospital', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '72037', 'city': 'Le Mans', 'country': 'France', 'facility': 'Le Mans University Hospital', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '29107', 'city': 'Quimper', 'country': 'France', 'facility': 'Quimper Hospital', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '44600', 'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'Hospital of Saint Nazaire', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Tours University Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Joel JENVRIN, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}