Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-01 @ 5:20 PM
Study NCT ID:
NCT02432456
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2015-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012253', 'term': 'Rib Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'D008721', 'term': 'Methocarbamol'}, {'id': 'D000701', 'term': 'Analgesics, Opioid'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D009294', 'term': 'Narcotics'}], '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': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D048448', 'term': 'Phenylcarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D006140', 'term': 'Guaifenesin'}, {'id': 'D006139', 'term': 'Guaiacol'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tcarver@mcw.edu', 'phone': '414-955-1733', 'title': 'Thomas Carver', 'organization': 'Medical College of Wisconsin'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'NPS presents challenges as pain is subjective and difficult to assess. Treating providers were allowed any medications within the multimodal rib fracture pain protocol leading to non-standardized pain regimens based on providers.'}}, 'adverseEventsModule': {'timeFrame': 'Data was collected for the duration of all participants hospitalizations. At time of discharge adverse event recording was stopped as patients were monitored throughout only their index stay defined up to 365 days.', 'description': 'All adverse events were reported and reviewed by the IRB at our insitution.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 15, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 7, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Delirium', 'notes': 'Delirium as outlined by positive CAM testing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'notes': 'Concern on nursing that patient was sedated as result of over medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'notes': 'Need for intubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Numeric Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}], 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '2', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-24 hours post infusion', 'description': 'Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'type': 'SECONDARY', 'title': 'Visual Analog Numeric Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}], 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-48 hours post infusion', 'description': 'Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'type': 'SECONDARY', 'title': 'Oral Morphine Equivalent (Narcotic Usage)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}], 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '295'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '187.2'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '131'}, {'value': '21.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '203'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12-24 hours post infusion', 'description': 'This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.', 'unitOfMeasure': 'oral morphine equivalents', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'type': 'SECONDARY', 'title': 'Oral Morphine Equivalent (Narcotic Usage)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}], 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1201.0'}, {'value': '69.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '656.5'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '302'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '765'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24-48 hours post infusion', 'description': 'This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.', 'unitOfMeasure': 'oral morphine equivalents', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}], 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '33'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '20'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '109'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Total Index Hospitalization up to 365 days', 'description': 'Total hospital length of stay in days up to 365 days.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'type': 'SECONDARY', 'title': 'Regional Anesthesia Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}], 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Total Index Hospitalization up to 365 days', 'description': 'This is a measure of the Epidural Placement rates. Epidural placement was binary as in patient received or did not receive an epidural infusion catheter for supplemental pain management.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'type': 'SECONDARY', 'title': 'Respiratory Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}], 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total Index Hospitalization up to 365 days', 'description': 'Respiratory failure within this trial was defined by the need for unanticipated intubation and/or transfer to ICU for respiratory support.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'type': 'SECONDARY', 'title': 'Hallucination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}], 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total Index Hospitalization up to 365 days', 'description': 'Hallucinations were documented and confirmed by the treating medical team.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'type': 'SECONDARY', 'title': 'Oral Morphine Equivalent (Narcotic Usage) in Severely Injured', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}], 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '170.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1589.0'}, {'value': '153.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '758.5'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '376'}, {'value': '67.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '988'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Total Index Hospitalization up to 365 days', 'description': 'This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.', 'unitOfMeasure': 'oral morphine equivalents', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 45 participants were categorized as severely injured within the adult trial. A total of 24 participants were categorized as severely injured within the elderly trial.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'FG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Adult Study: From August 2015 to December of 2017, all adult blunt trauma patients with three or more rib fractures were screened for eligibility in this study.\n\nElderly Study: From August 2015 to June 2018, all elderly blunt trauma patients with three or more rib fractures were screened for eligibility in the study.', 'preAssignmentDetails': '153 patients agreed to participate. Three subjects (two from elderly and one from adult) were randomized but withdrawn prior to collecting any data or initiation of the infusions. This left a total of 150 participants within the trial, of which 75 were randomized to the placebo infusion with the other 75 randomized to the ketamine infusion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Infusion', 'description': 'Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.'}, {'id': 'BG001', 'title': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'title': 'Adult BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'BG000', 'lowerLimit': '18.7', 'upperLimit': '50'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '18.3', 'upperLimit': '51.7'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '18.3', 'upperLimit': '51.7'}]}]}, {'title': 'Elderly BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'BG000', 'lowerLimit': '20.6', 'upperLimit': '39.7'}, {'value': '29.2', 'groupId': 'BG001', 'lowerLimit': '22.5', 'upperLimit': '38'}, {'value': '27.7', 'groupId': 'BG002', 'lowerLimit': '20.6', 'upperLimit': '39.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'title': 'Number of Rib Fractures', 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '6.4', 'spread': '3.2', 'groupId': 'BG002'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '6.3', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Rib Fractures', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'title': 'Flail Chest', 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'title': 'Injury Severity Score, median', 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '38'}, {'value': '17', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '34'}, {'value': '14', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '38'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '48'}, {'value': '13', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '41'}, {'value': '13', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '48'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Injury Severity Scale Score', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Injury severity of each of 6 body systems is scored according the Abbreviated Injury Scale. Three body systems with the highest AIS scores are used to calculate the Injury Severity Score (ISS). These scores are squared and the results summed to produce the Injury Severity Score which ranges from 3-75. The higher the ISS the greater the injury.'}, {'title': 'Injury Severity Score greater than15', 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'title': 'ICU Admission', 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'title': 'Motor Vehicle Collision', 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'title': 'Fall', 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}, {'title': 'Other Mechanism of Injury', 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Elderly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-01', 'size': 795629, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-15T11:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2015-04-20', 'resultsFirstSubmitDate': '2019-12-15', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-27', 'studyFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Numeric Pain Score', 'timeFrame': '12-24 hours post infusion', 'description': 'Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Numeric Pain Score', 'timeFrame': '24-48 hours post infusion', 'description': 'Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable.'}, {'measure': 'Oral Morphine Equivalent (Narcotic Usage)', 'timeFrame': '12-24 hours post infusion', 'description': 'This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.'}, {'measure': 'Oral Morphine Equivalent (Narcotic Usage)', 'timeFrame': '24-48 hours post infusion', 'description': 'This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.'}, {'measure': 'Length of Stay', 'timeFrame': 'Total Index Hospitalization up to 365 days', 'description': 'Total hospital length of stay in days up to 365 days.'}, {'measure': 'Regional Anesthesia Utilization', 'timeFrame': 'Total Index Hospitalization up to 365 days', 'description': 'This is a measure of the Epidural Placement rates. Epidural placement was binary as in patient received or did not receive an epidural infusion catheter for supplemental pain management.'}, {'measure': 'Respiratory Failure', 'timeFrame': 'Total Index Hospitalization up to 365 days', 'description': 'Respiratory failure within this trial was defined by the need for unanticipated intubation and/or transfer to ICU for respiratory support.'}, {'measure': 'Hallucination', 'timeFrame': 'Total Index Hospitalization up to 365 days', 'description': 'Hallucinations were documented and confirmed by the treating medical team.'}, {'measure': 'Oral Morphine Equivalent (Narcotic Usage) in Severely Injured', 'timeFrame': 'Total Index Hospitalization up to 365 days', 'description': 'This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wounds and Injuries', 'Rib Fractures']}, 'referencesModule': {'references': [{'pmid': '30376537', 'type': 'DERIVED', 'citation': 'Carver TW, Kugler NW, Juul J, Peppard WJ, Drescher KM, Somberg LB, Szabo A, Yin Z, Paul JS. Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. J Trauma Acute Care Surg. 2019 Feb;86(2):181-188. doi: 10.1097/TA.0000000000002103.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effectiveness of ketamine infusions in the management of acute pain resulting from broken ribs suffered following a blunt trauma. Half of patients will receive the institutional standard of care and a placebo infusion (no active medication). The other half of patients will receive the institutional standard of care and a ketamine infusion. All subjects and staff will be blinded as to whether they are receiving placebo or ketamine.', 'detailedDescription': 'A prospective randomized, double blinded trial of ketamine use in adult and elderly blunt trauma patients with associated rib fractures admitted to the trauma service will be conducted. Examples of blunt mechanisms include assault, falls, motor vehicle collisions, motorcycle crashes, motor vehicle pedestrian collisions, crush injuries, and bicycle accidents. The experimental arm of the trial will receive ketamine infusion therapy while the control arm receives saline placebo infusions at an equivalent rate. All patients will be managed with adjunct therapy including opiates in accordance with the institutional thoracic trauma protocols. Two separate trials based on patient age are included in this study. Elderly rib fracture patients are certainly of interest but will be evaluated as a distinct entity given the discrete differences in the complications of rib fractures and the goals of therapy.\n\nAll blunt trauma patients with associated rib fractures will be screened. All patients will be enrolled into the institutional standard thoracic trauma pathway. All individuals will undergo Intercostal Nerve Block (ICNB) in the Emergency Department or on admission to the Intensive Care Unit. In addition to scheduled medications per institutional thoracic trauma protocols, all patients will receive adjunct opiate therapy. Patients will be screened by the clinical and pharmacy staff following the diagnosis of rib fractures for eligibility. Patients enrolled into the trial will be randomized into either the experimental or control arm of the trial. The Investigational Drug Services (IDS) department will randomize all enrollees and handle administration of all trial drugs. The infusate will be mixed by the IDS department and all bags will be labeled "Ketamine / Placebo." The IDS department will have unique bag identifiers, which will allow them to identify which bags have active ketamine and which are placebo in case of emergency.\n\nPatients will be randomized in a 1:1 fashion for experimental and control arms. Those enrolled in the experimental arm will receive early ketamine infusion therapy at a fixed infusion rate. For those enrolled in the adult trial the infusion rate will be 2.5 mcg/kg/min while those in the elderly trial will receive infusions at 2.0 mcg/kg/min. All ketamine infusions will be calculated based on ideal body weight (IBW), unless actual body weight is less than ideal. IBW will be calculated for males as 50kg + 2.3\\*(number of inches above 5 feet) and for women as 45.5kg + 2.3\\*(number of inches over 5 feet). Patients randomized to the control arm will receive placebo saline solution at an equivalent rate. Time zero will be defined as the time at which the "ketamine / placebo" infusion is begun. For inclusion in the trial, initiation of ketamine / placebo infusions must take place within 6 hours of presentation to Froedtert Memorial Lutheran Hospital (FMLH). Ketamine infusion therapy will be continued for 48 hours. At 6-8 hours post-ICNB all subjects will be assessed for need for repeat ICNB. Need for repeat ICNB will be defined by a thoracic specific numeric pain score greater than seven. Between eight and ten hours post-ketamine infusion initiation, subjects who have thoracic specific pain scores above seven will be evaluated for epidural placement by the Regional Anesthesia and Acute Pain Service.\n\nA subject will be allowed to remove himself/herself from the trial or be un-blinded should he/she, pharmacy, anesthesia, and/or surgical staff deem it medically necessary. Medical necessity would be determined by inability to treat the patient appropriately without knowledge of trial assignment; otherwise the assumption of treating staff will be all patients have received ketamine. All adverse events will be recorded and if necessary subjects will be un-blinded in the event of a serious adverse event. The trauma and anesthesia teams along with the inpatient clinical pharmacists will monitor all trial patients for any adverse event trends. Patients will be followed through the time of discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age greater than 18 years\n2. rib fractures following recent trauma with admission to Froedtert Memorial Lutheran Hospital\n\nExclusion Criteria:\n\n1. history of adverse reaction / intolerance to ketamine therapy\n2. elevated intracranial pressure\n3. ischemic heart disease defined as active acute coronary syndrome\n4. severe, poorly controlled hypertension (Systolic Blood Pressure \\> 200 mmHg or Diastolic Blood Pressure \\> 100 mmHg)\n5. current opiate agonist/antagonist therapy\n6. concurrent use of monoamine oxidase inhibitors (MAOIs)\n7. chronic pain or opioid tolerance defined as \\> 3 weeks of \\>30mg oral morphine equivalents per day\n8. current substance abuse with opiates (prescription and/or heroin) or ketamine\n9. Glasgow Coma Scale \\<13\n10. Intubation on arrival or need for urgent intubation on arrival\n11. inability to delineate pain and/or appropriately communicate with staff\n12. history of psychosis\n13. three or more psychotropic medications\n14. active delirium\n15. glaucoma\n16. pregnancy\n17. prisoners'}, 'identificationModule': {'nctId': 'NCT02432456', 'briefTitle': 'Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients', 'orgStudyIdInfo': {'id': 'PRO00024679'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.\n\nAll patients will undergo Intercostal Nerve Blockade with administration of scheduled medications including acetaminophen, ibuprofen, pantoprazole, and methocarbamol. All subjects will receive adjunct opioids.', 'interventionNames': ['Drug: Placebo', 'Procedure: Intercostal Nerve Block', 'Drug: Acetaminophen', 'Drug: Ibuprofen', 'Drug: Pantoprazole', 'Drug: Methocarbamol', 'Drug: Opioid']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine Infusion', 'description': 'Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion.\n\nAll patients will undergo Intercostal Nerve Blockade with administration of scheduled medications including acetaminophen, ibuprofen, pantoprazole, and methocarbamol. All subjects will receive adjunct opioids.', 'interventionNames': ['Drug: Ketamine', 'Procedure: Intercostal Nerve Block', 'Drug: Acetaminophen', 'Drug: Ibuprofen', 'Drug: Pantoprazole', 'Drug: Methocarbamol', 'Drug: Opioid']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'All individuals randomized to the experimental arm of the trial will receive early ketamine therapy (within 6 hours of admission) at a rate of 0.15 mg/kg/hr dosed based on ideal body weight. Individuals in the control arm will receive our standard of care for thoracic trauma patients, however, they will receive an additional placebo infusion of normal saline.', 'armGroupLabels': ['Ketamine Infusion']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['NaCl Placebo Solution'], 'description': 'Individuals enrolled into the control arm of the trial will receive a normal saline placebo infusion at a rate equivalent to the dosage of ketamine in the experimental arm.', 'armGroupLabels': ['Placebo Infusion']}, {'name': 'Intercostal Nerve Block', 'type': 'PROCEDURE', 'otherNames': ['Rib Block'], 'description': 'All individuals enrolled into the trial will undergo an Intercostal Nerve Blockade as a part of the institutional standard of care for rib fractures. This procedure will be performed according to current standard protocols in the Emergency Department or on admission.', 'armGroupLabels': ['Ketamine Infusion', 'Placebo Infusion']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'All patients admitted to the hospital will be placed on scheduled acetaminophen 1000mg PO q 6 hours unless signs of liver disease/impairment or creatinine clearance \\< 35ml/min at which point dosage would be reduced to 650mg q 8 hours. Individuals unable to take oral medications would be placed on intravenous acetaminophen.', 'armGroupLabels': ['Ketamine Infusion', 'Placebo Infusion']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['Advil, Motrin'], 'description': 'All patients will be placed on scheduled Ibuprofen or an equivalent NSAID at dosage of 600mg every 6 hours. Patients must have a Glomerular Filtration Rate \\> 60 ml/min with no contraindications to NSAID therapy (e.g. Aspirin use, allergy/sensitivity, concurrent ACE inhibitor use, other nephrotoxins, etc)', 'armGroupLabels': ['Ketamine Infusion', 'Placebo Infusion']}, {'name': 'Pantoprazole', 'type': 'DRUG', 'otherNames': ['Protonix'], 'description': 'All individuals on scheduled Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy will receive scheduled pantoprazole at 40mg daily. Individuals unable to take medications orally will be placed on intravenous therapy. Individuals with previous reaction or intolerance to pantoprazole will be placed on an equivalent proton pump inhibitor.', 'armGroupLabels': ['Ketamine Infusion', 'Placebo Infusion']}, {'name': 'Methocarbamol', 'type': 'DRUG', 'otherNames': ['Robaxin'], 'description': 'All individuals enrolled in the trial will be placed on scheduled methocarbamol 500 mg orally every 6 hours while admitted. Individuals with previous intolerance to methocarbamol will be placed on a pharmacy directed equivalent.', 'armGroupLabels': ['Ketamine Infusion', 'Placebo Infusion']}, {'name': 'Opioid', 'type': 'DRUG', 'otherNames': ['opiate, narcotic'], 'description': 'All individuals will receive as needed opiate therapy as an adjunct to the scheduled medications and "ketamine/placebo" solution. Choice in opiate therapy will be at the discretion of the attending trauma faculty. Dosage and adjustments will be in accordance with the institutional policy on appropriate opiate dosage adjustment.', 'armGroupLabels': ['Ketamine Infusion', 'Placebo Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Memorial Lutheran Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Thomas W Carver, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lead Research Resident', 'investigatorFullName': 'Nathan Kugler', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}