Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT03464461
Status:
TERMINATED
Last Update Posted:
2024-11-05
First Post:
2018-03-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dosing of Ketorolac in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-15', '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': 'D020910', 'term': 'Ketorolac'}], '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': 'robinsonmt@health.missouri.edu', 'phone': '573 884-4400', 'title': 'Dr. Matthew Robinson', 'organization': 'University of Missouri'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study enrollment ended early, resulting in less than half of the number of participants needed according to the power analysis. Our study site was closed to enrollment during the recent pandemic, and there was major supply chain issues for saline and IV equipment. Ultimately the study was closed due to the extenuating circumstances.'}}, 'adverseEventsModule': {'timeFrame': 'Approximately 40 minutes, from the time of consent until post-treatment pain score was obtained', 'eventGroups': [{'id': 'EG000', 'title': '0 mg', 'description': '0 mg ketorolac - placebo\n\nKetorolac: IV drug', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 0, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '10 mg', 'description': '10 mg ketorolac - low dose ketorolac\n\nKetorolac: IV drug', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 0, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '30 mg', 'description': '30 mg ketorolac - usual dose ketorolac\n\nKetorolac: IV drug', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 0, 'seriousNumAtRisk': 83, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 mg', 'description': '0 mg ketorolac - placebo\n\nKetorolac: IV drug'}, {'id': 'OG001', 'title': '10 mg', 'description': '10 mg ketorolac - low dose ketorolac\n\nKetorolac: IV drug'}, {'id': 'OG002', 'title': '30 mg', 'description': '30 mg ketorolac - usual dose ketorolac\n\nKetorolac: IV drug'}], 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '19.4', 'groupId': 'OG001'}, {'value': '16.7', 'spread': '20.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9844', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'non-parametric'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'The outcome measure is the average change in pain score.\n\nChange in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group.\n\nThe pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients presenting to the Emergency Department with pain that falls in one of the for categories: abdominal, headache, trauma/musculoskeletal, viral'}, {'type': 'PRIMARY', 'title': 'Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 mg', 'description': '0 mg ketorolac - placebo\n\nKetorolac: IV drug'}, {'id': 'OG001', 'title': '10 mg', 'description': '10 mg ketorolac - low dose ketorolac\n\nKetorolac: IV drug'}, {'id': 'OG002', 'title': '30 mg', 'description': '30 mg ketorolac - usual dose ketorolac\n\nKetorolac: IV drug'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '22.1', 'spread': '21.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1580', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'non-parametric'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group.\n\nThe pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients presenting to the Emergency Department with abdominal pain'}, {'type': 'PRIMARY', 'title': 'Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 mg', 'description': '0 mg ketorolac - placebo\n\nKetorolac: IV drug'}, {'id': 'OG001', 'title': '10 mg', 'description': '10 mg ketorolac - low dose ketorolac\n\nKetorolac: IV drug'}, {'id': 'OG002', 'title': '30 mg', 'description': '30 mg ketorolac - usual dose ketorolac\n\nKetorolac: IV drug'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '18.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8730', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'non-parametric'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group.\n\nThe pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients presenting to the Emergency Department with headache'}, {'type': 'PRIMARY', 'title': 'Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 mg', 'description': '0 mg ketorolac - placebo\n\nKetorolac: IV drug'}, {'id': 'OG001', 'title': '10 mg', 'description': '10 mg ketorolac - low dose ketorolac\n\nKetorolac: IV drug'}, {'id': 'OG002', 'title': '30 mg', 'description': '30 mg ketorolac - usual dose ketorolac\n\nKetorolac: IV drug'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '19.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0740', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'non-parametric'}], 'paramType': 'MEAN', 'timeFrame': '30 min', 'description': 'The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group.\n\nThe pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients presenting to the Emergency Department with trauma/musculoskeletal pain'}, {'type': 'PRIMARY', 'title': 'Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0 mg', 'description': '0 mg ketorolac - placebo\n\nKetorolac: IV drug'}, {'id': 'OG001', 'title': '10 mg', 'description': '10 mg ketorolac - low dose ketorolac\n\nKetorolac: IV drug'}, {'id': 'OG002', 'title': '30 mg', 'description': '30 mg ketorolac - usual dose ketorolac\n\nKetorolac: IV drug'}], 'classes': [{'categories': [{'measurements': [{'value': '21.8', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '17.5', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '15.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0984', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'non-parametric'}], 'paramType': 'MEAN', 'timeFrame': '30 min', 'description': 'The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group.\n\nThe pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients presenting to the Emergency Department with viral pain'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0 mg', 'description': '0 mg ketorolac - placebo\n\nKetorolac: IV drug'}, {'id': 'FG001', 'title': '10 mg', 'description': '10 mg ketorolac - low dose ketorolac\n\nKetorolac: IV drug'}, {'id': 'FG002', 'title': '30 mg', 'description': '30 mg ketorolac - usual dose ketorolac\n\nKetorolac: IV drug'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'exclusionary medication given ,', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants were excluded if they were giving medications that could interfere with study results, if study medication could not be administered, at the providers discretion, or if the participant decided to withdraw from the study.\n\n31 participants signed consent but withdrew/were excluded before study drug administration 4 participants were excluded after study drug administration (see below)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '0 mg', 'description': '0 mg ketorolac - placebo\n\nKetorolac: IV drug'}, {'id': 'BG001', 'title': '10 mg', 'description': '10 mg ketorolac - low dose ketorolac\n\nKetorolac: IV drug'}, {'id': 'BG002', 'title': '30 mg', 'description': '30 mg ketorolac - usual dose ketorolac\n\nKetorolac: IV drug'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '44', 'spread': '17', 'groupId': 'BG000'}, {'value': '44', 'spread': '16', 'groupId': 'BG001'}, {'value': '41', 'spread': '16', 'groupId': 'BG002'}, {'value': '43', 'spread': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], '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': '82', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Pain Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '67.2', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '65.3', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '16.7', 'groupId': 'BG002'}, {'value': '66.30', 'spread': '21.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The average number of millimeters measured from the 0mm end of the 100mm long Visual Analog Scale (VAS) line to the mark on the line made by the participants indicating their pain level before given the study treatment.', 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-12', 'size': 254593, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-15T10:02', 'hasProtocol': True}, {'date': '2022-03-09', 'size': 344431, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-28T10:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'blinded drug'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '4 groups with 3 different treatments'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}}, 'statusModule': {'whyStopped': 'Pandemic related supply shortages and slowed enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2018-03-07', 'resultsFirstSubmitDate': '2024-09-19', 'studyFirstSubmitQcDate': '2018-03-07', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-16', 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type', 'timeFrame': '30 minutes', 'description': 'The outcome measure is the average change in pain score.\n\nChange in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group.\n\nThe pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.'}, {'measure': 'Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain', 'timeFrame': '30 minutes', 'description': 'The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group.\n\nThe pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.'}, {'measure': 'Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache', 'timeFrame': '30 minutes', 'description': 'The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group.\n\nThe pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.'}, {'measure': 'Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain', 'timeFrame': '30 min', 'description': 'The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group.\n\nThe pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.'}, {'measure': 'Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain', 'timeFrame': '30 min', 'description': 'The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group.\n\nThe pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'descriptionModule': {'briefSummary': 'The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.', 'detailedDescription': 'Patients from 4 groups will be treated with 3 different doses of ketorolac. The groups are 1. headache 2. abdominal pain 3. musculo-skeletal pain 4. viral syndrome. The doses will be 0, 10, 30mgs of ketorolac to clarify the placebo effect and the optimal dosage as a function of condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\> 18 y/o\n\nExclusion Criteria:\n\npregnant allergic other contraindication'}, 'identificationModule': {'nctId': 'NCT03464461', 'briefTitle': 'Dosing of Ketorolac in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department', 'orgStudyIdInfo': {'id': '2010856'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '0 mg', 'description': '0 mg ketorolac - placebo', 'interventionNames': ['Drug: Ketorolac']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10 mg', 'description': '10 mg ketorolac - low dose ketorolac', 'interventionNames': ['Drug: Ketorolac']}, {'type': 'ACTIVE_COMPARATOR', 'label': '30 mg', 'description': '30 mg ketorolac - usual dose ketorolac', 'interventionNames': ['Drug: Ketorolac']}], 'interventions': [{'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['Use of placebo, low, usual dose ketorolac'], 'description': 'IV drug', 'armGroupLabels': ['0 mg', '10 mg', '30 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Health Care', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Matthew Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Matthew Robinson', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}