Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
Study NCT ID:
NCT02078492
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2014-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D020911', 'term': 'Ketorolac Tromethamine'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smotov@maimonidesmed.org', 'phone': '718-283-8693', 'title': 'Dr. Sergey Motov', 'organization': 'Maimonides Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1 - 10 mg of Ketorolac', 'description': 'Subjects will be administered 10 mg of Ketorolac for pain relief.\n\n10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.', 'otherNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2 - 15mg', 'description': 'Subjects will be administered 15mg of Ketorolac.\n\n15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.', 'otherNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3 - 30mg', 'description': 'Subject will receive 30mg of Ketorolac as a part of standard care.\n\n30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.', 'otherNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score at 30 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - 10 mg of Ketorolac', 'description': 'Subjects will be administered 10 mg of Ketorolac for pain relief.\n\n10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.'}, {'id': 'OG001', 'title': 'Group 2 - 15mg', 'description': 'Subjects will be administered 15mg of Ketorolac.\n\n15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.'}, {'id': 'OG002', 'title': 'Group 3 - 30mg', 'description': 'Subject will receive 30mg of Ketorolac as a part of standard care.\n\n30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.14', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '5.05', 'spread': '2.56', 'groupId': 'OG001'}, {'value': '4.81', 'spread': '2.85', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.', 'unitOfMeasure': 'pain score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Effect of Dizziness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - 10 mg of Ketorolac', 'description': 'Subjects will be administered 10 mg of Ketorolac for pain relief.\n\n10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.'}, {'id': 'OG001', 'title': 'Group 2 - 15mg', 'description': 'Subjects will be administered 15mg of Ketorolac.\n\n15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.'}, {'id': 'OG002', 'title': 'Group 3 - 30mg', 'description': 'Subject will receive 30mg of Ketorolac as a part of standard care.\n\n30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 minutes', 'description': 'the number of study patients who reported having dizziness after administration of medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Effect of Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - 10 mg of Ketorolac', 'description': 'Subjects will be administered 10 mg of Ketorolac for pain relief.\n\n10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.'}, {'id': 'OG001', 'title': 'Group 2 - 15mg', 'description': 'Subjects will be administered 15mg of Ketorolac.\n\n15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.'}, {'id': 'OG002', 'title': 'Group 3 - 30mg', 'description': 'Subject will receive 30mg of Ketorolac as a part of standard care.\n\n30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 minutes', 'description': 'The number of study patients who reported nausea after administration of medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Effect of Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - 10 mg of Ketorolac', 'description': 'Subjects will be administered 10 mg of Ketorolac for pain relief.\n\n10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.'}, {'id': 'OG001', 'title': 'Group 2 - 15mg', 'description': 'Subjects will be administered 15mg of Ketorolac.\n\n15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.'}, {'id': 'OG002', 'title': 'Group 3 - 30mg', 'description': 'Subject will receive 30mg of Ketorolac as a part of standard care.\n\n30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.783', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The main hypothesis was that there would be equivalence of dose effect across the three groups at every time point, and the primary comparison consisted of the pain assessment at 30 minutes.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': '2 degrees of freedom', 'nonInferiorityComment': 'We assumed a minimal clinically significant difference (MCSD) of 1.3 between the three ketorolac groups at the 30-minute pain assessment and a standard deviation of 3.0. A power analysis determined that a sample of 78 subjects per group provided at least 80% power to detect an MCSD of at least 1.3 at 30 minutes with α=0.05.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 minutes', 'description': 'The number of study patients who reported headache after administration of medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 - 10 mg of Ketorolac', 'description': 'Subjects will be administered 10 mg of Ketorolac for pain relief.\n\n10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.'}, {'id': 'FG001', 'title': 'Group 2 - 15mg', 'description': 'Subjects will be administered 15mg of Ketorolac.\n\n15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.'}, {'id': 'FG002', 'title': 'Group 3 - 30mg', 'description': 'Subject will receive 30mg of Ketorolac as a part of standard care.\n\n30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 - 10 mg of Ketorolac', 'description': 'Subjects will be administered 10 mg of Ketorolac for pain relief.\n\n10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.'}, {'id': 'BG001', 'title': 'Group 2 - 15mg', 'description': 'Subjects will be administered 15mg of Ketorolac.\n\n15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.'}, {'id': 'BG002', 'title': 'Group 3 - 30mg', 'description': 'Subject will receive 30mg of Ketorolac as a part of standard care.\n\n30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '38.8', 'spread': '11.6', 'groupId': 'BG002'}, {'value': '40.2', 'spread': '11.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-25', 'studyFirstSubmitDate': '2014-03-03', 'resultsFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2014-03-03', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-25', 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score at 30 Minutes', 'timeFrame': '30 minutes', 'description': 'Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.'}], 'secondaryOutcomes': [{'measure': 'Adverse Effect of Dizziness', 'timeFrame': '120 minutes', 'description': 'the number of study patients who reported having dizziness after administration of medication.'}, {'measure': 'Adverse Effect of Nausea', 'timeFrame': '120 minutes', 'description': 'The number of study patients who reported nausea after administration of medication'}, {'measure': 'Adverse Effect of Headache', 'timeFrame': '120 minutes', 'description': 'The number of study patients who reported headache after administration of medication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '8655940', 'type': 'BACKGROUND', 'citation': 'Catapano MS. The analgesic efficacy of ketorolac for acute pain. J Emerg Med. 1996 Jan-Feb;14(1):67-75. doi: 10.1016/0736-4679(95)02052-7.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.', 'detailedDescription': 'Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED) for the treatment of moderate-to-severe pain. Ketorolac is available in both oral and parenteral forms and possess significant analgesic potency. However, ketorolac provides few advantages over other currently available analgesics and its use is limited by a virtue of having an "analgesic ceiling" with the dose being 10mg as well as having a range of severe side effects, of which gastrointestinal hemorrhage is most concerning.The concept of an analgesic ceiling is that doses beyond this value (10mg) do not provide additional analgesia and do contribute to side effects. In spite of this, the majority of research conducted on ketorolac in the ED and recommendations in Tintinalli\'s Emergency Medicine Textbook advocating for use of three-to-six fold higher dosages.\n\nHypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSevere flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain.\n\nExclusion Criteria:\n\nAge \\>65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.'}, 'identificationModule': {'nctId': 'NCT02078492', 'briefTitle': 'A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'Maimonides Medical Center'}, 'officialTitle': 'A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management in the Emergency Department"', 'orgStudyIdInfo': {'id': '2014-01-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 - 10 mg of Ketorolac', 'description': 'Subjects will be administered 10 mg of Ketorolac for pain relief.', 'interventionNames': ['Drug: 10 mg of Ketorolac']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - 15mg', 'description': 'Subjects will be administered 15mg of Ketorolac.', 'interventionNames': ['Drug: 15 mg of Ketorolac']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 - 30mg', 'description': 'Subject will receive 30mg of Ketorolac as a part of standard care.', 'interventionNames': ['Drug: 30 mg of Ketorolac']}], 'interventions': [{'name': '10 mg of Ketorolac', 'type': 'DRUG', 'otherNames': ['Toradol'], 'description': 'Patients will receive 10 mg of Ketorolac for pain control.', 'armGroupLabels': ['Group 1 - 10 mg of Ketorolac']}, {'name': '15 mg of Ketorolac', 'type': 'DRUG', 'otherNames': ['Toradol'], 'description': 'Patients will receive 15mg of Ketorolac for pain control.', 'armGroupLabels': ['Group 2 - 15mg']}, {'name': '30 mg of Ketorolac', 'type': 'DRUG', 'otherNames': ['Toradol'], 'description': 'Patients will receive 30mg of Ketorolac for pain control.', 'armGroupLabels': ['Group 3 - 30mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11219', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Sergey Motov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Attending'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antonios Likourezos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Manager', 'investigatorFullName': 'Antonios Likourezos', 'investigatorAffiliation': 'Maimonides Medical Center'}}}}