Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT03714620
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2018-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sub-dissociative Dose Ketamine Dosing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'slovett@lumc.edu', 'phone': '7082168705', 'title': 'Shannon Lovett, MD, Associate Professor of Emergency Medicine', 'organization': 'Trinity Health, Loyola University Medical Center, Stritch School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '60 minutes', 'description': 'The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.', 'eventGroups': [{'id': 'EG000', 'title': '0.15 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 28, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.3 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 31, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'notes': 'Experienced feeling of fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Feeling dizzy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Feeling Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling of Unreality', 'notes': 'Feeling out of body/unreality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hearing Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood Alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.15 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}, {'id': 'OG001', 'title': '0.3 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '4.7'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '4.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pain Score From Baseline to 15 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.15 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}, {'id': 'OG001', 'title': '0.3 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '4.4'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pain Score From Baseline to 60 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.15 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}, {'id': 'OG001', 'title': '0.3 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '4.6'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Need Additional Pain Medication at 30 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.15 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}, {'id': 'OG001', 'title': '0.3 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes', 'description': 'Patient request for additional pain medications at 30 minutes post initiation of drug administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Need Rescue Medications at 60 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.15 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}, {'id': 'OG001', 'title': '0.3 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 minutes', 'description': 'Patient request for additional pain medications at 60 minutes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Effects at 30 Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.15 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}, {'id': 'OG001', 'title': '0.3 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Feeling of Unreality', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hearing Changes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Vision Changes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Mood Alteration', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Discomfort', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Hallucinations', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'description': 'Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose Group', 'description': '0.15 mg/kg dose of intravenous ketamine'}, {'id': 'FG001', 'title': 'High Dose Group', 'description': '0.3 mg/kg dose of intravenous ketamine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '0.15 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}, {'id': 'BG001', 'title': '0.3 mg/kg IV Ketamine', 'description': 'Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '42'}, {'value': '37', 'groupId': 'BG001', 'lowerLimit': '34', 'upperLimit': '41'}, {'value': '38', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '42'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Co-morbidities', 'classes': [{'title': 'Diabetes', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Cancer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Heart Failure', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Obesity', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000', 'lowerLimit': '81', 'upperLimit': '90'}, {'value': '84', 'groupId': 'BG001', 'lowerLimit': '80', 'upperLimit': '89'}, {'value': '84', 'groupId': 'BG002', 'lowerLimit': '80', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Type of Pain', 'classes': [{'categories': [{'title': 'Flank', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Back', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Musculoskeletal', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Headache', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Abdominal', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Pain', 'classes': [{'categories': [{'title': '<24 hours', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': '2 days', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '3-7 days', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-17', 'size': 97129, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-12T13:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All study investigators, patients and clinicians except the clinical pharmacist will be blinded to the study treatment allocation. Treatment will be prepared and blinded by the ED clinical pharmacist.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2018-10-17', 'resultsFirstSubmitDate': '2022-05-09', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-08', 'studyFirstPostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration', 'timeFrame': '30 minutes', 'description': 'Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Score From Baseline to 15 Minutes', 'timeFrame': '15 minutes', 'description': 'Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.'}, {'measure': 'Change in Pain Score From Baseline to 60 Minutes', 'timeFrame': '60 minutes', 'description': 'Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.'}, {'measure': 'Number of Participants Who Need Additional Pain Medication at 30 Minutes', 'timeFrame': '30 minutes', 'description': 'Patient request for additional pain medications at 30 minutes post initiation of drug administration'}, {'measure': 'Number of Patients Who Need Rescue Medications at 60 Minutes', 'timeFrame': '60 minutes', 'description': 'Patient request for additional pain medications at 60 minutes'}, {'measure': 'Adverse Effects at 30 Min', 'timeFrame': '30 minutes', 'description': 'Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'descriptionModule': {'briefSummary': 'Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.', 'detailedDescription': 'Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups.\n\nInvestigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults ages 18-59\n* Weight 45 - 115 kg\n* Acute abdominal, flank, back, musculoskeletal pain, or a headache\n* Onset of pain within 7 days\n* Pain score of 5 or more\n* Requiring intravenous analgesia\n* Hasn't been enrolled in this study previously\n\nExclusion Criteria:\n\n* Pregnancy\n* Breast-feeding\n* Altered mental status rendering the patient unable to consent to the study\n* Allergy to ketamine\n* Unstable vital signs (systolic blood pressure \\<90 or \\>180 mm Hg, pulse rate \\<50 or \\>150 beats/minute, and respiration rate \\<10 or \\>30 breaths/minute)\n* History of acute head or eye injury, seizure, intracranial hypertension\n* Chronic pain\n* Renal or hepatic insufficiency\n* Known alcohol or drug use disorder\n* Currently under influence of alcohol/opiates\n* Acute psychiatric illness"}, 'identificationModule': {'nctId': 'NCT03714620', 'briefTitle': 'Sub-dissociative Dose Ketamine Dosing Study', 'organization': {'class': 'OTHER', 'fullName': 'Loyola University'}, 'officialTitle': 'A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department', 'orgStudyIdInfo': {'id': '211328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0.15 mg/kg IV Ketamine', 'interventionNames': ['Drug: Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.3 mg/kg IV Ketamine', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes', 'armGroupLabels': ['0.15 mg/kg IV Ketamine', '0.3 mg/kg IV Ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}], 'overallOfficials': [{'name': 'Shannon Lovett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loyola University Chicago, LUMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loyola University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Department of Emergency Medicine', 'investigatorFullName': 'Shannon Lovett', 'investigatorAffiliation': 'Loyola University'}}}}