Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 2:25 AM
Study NCT ID:
NCT04650893
Status:
TERMINATED
Last Update Posted:
2024-08-23
First Post:
2020-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D055154', 'term': 'Dysphonia'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peter.danielson@unmc.edu', 'phone': '402-559-1703', 'title': 'Peter Danielson', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'no steroid or non steroidal anti-inflammatory\n\nPlacebo: Control', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketorolac', 'description': 'one time dose of 30mg of IV Ketorolac at time of closure\n\nIntravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dexamethasone', 'description': 'one time dose of 10mg of IV dexamethasone at the time of closure\n\nIntravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Moderate/Severe Bazaz Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'no steroid or non steroidal anti-inflammatory\n\nPlacebo: Control'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': 'one time dose of 30mg of IV Ketorolac at time of closure\n\nIntravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}, {'id': 'OG002', 'title': 'Dexamethasone', 'description': 'one time dose of 10mg of IV dexamethasone at the time of closure\n\nIntravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one year', 'description': 'The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'no steroid or non steroidal anti-inflammatory\n\nPlacebo: Control'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': 'one time dose of 30mg of IV Ketorolac at time of closure\n\nIntravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}, {'id': 'OG002', 'title': 'Dexamethasone', 'description': 'one time dose of 10mg of IV dexamethasone at the time of closure\n\nIntravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one year', 'description': 'Percentage of patients with severe dysphagia based on the Eating Assessment Tool (EAT-10).Scores on the EAT-10 greater than 15 are indicative of severe dysphonia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'no steroid or non steroidal anti-inflammatory\n\nPlacebo: Control'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': 'one time dose of 30mg of IV Ketorolac at time of closure\n\nIntravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}, {'id': 'OG002', 'title': 'Dexamethasone', 'description': 'one time dose of 10mg of IV dexamethasone at the time of closure\n\nIntravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one year', 'description': 'Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No placeholder numbers included; only one participant completed study.'}, {'type': 'SECONDARY', 'title': 'Mean Neck Disability Index (NDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'no steroid or non steroidal anti-inflammatory\n\nPlacebo: Control'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': 'one time dose of 30mg of IV Ketorolac at time of closure\n\nIntravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}, {'id': 'OG002', 'title': 'Dexamethasone', 'description': 'one time dose of 10mg of IV dexamethasone at the time of closure\n\nIntravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '38'}, {'value': '3.75', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one year', 'description': 'The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury. There are 10 sections, and each section contains 6 statements.The statements are scored from 0 to 5, with 0 indicating no disability and 5 indicating complete disability.\n\n0: No disability or difficulty\n\n1. Mild disability or difficulty\n2. Moderate disability or difficulty\n3. Severe disability or difficulty\n4. Very severe disability or difficulty\n5. Complete disability or difficulty\n\nTotal Score: The scores from each of the 10 sections are summed to calculate the total score. The maximum possible score is 50, which would indicate severe disability, while a score of 0 indicates no disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Median Visual Analogue Scale for Neck Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'no steroid or non steroidal anti-inflammatory\n\nPlacebo: Control'}, {'id': 'OG001', 'title': 'Ketorolac', 'description': 'one time dose of 30mg of IV Ketorolac at time of closure\n\nIntravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}, {'id': 'OG002', 'title': 'Dexamethasone', 'description': 'one time dose of 10mg of IV dexamethasone at the time of closure\n\nIntravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '1.75', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one year', 'description': 'The Visual analogue scale is a line with numbers underneath it, with extremes marked "no pain" score of 0 (left) and the "worst pain imaginable" score of 10 (right).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'no steroid or non steroidal anti-inflammatory\n\nPlacebo: Control'}, {'id': 'FG001', 'title': 'Ketorolac', 'description': 'one time dose of 30mg of IV Ketorolac at time of closure\n\nIntravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following anterior cervical discectomy and fusion (ACDF).'}, {'id': 'FG002', 'title': 'Dexamethasone', 'description': 'one time dose of 10mg of IV dexamethasone at the time of closure\n\nIntravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}]}]}], 'preAssignmentDetails': 'Study was terminated early, lack of compliance for follow-up intervals.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'no steroid or non steroidal anti-inflammatory\n\nPlacebo: Control'}, {'id': 'BG001', 'title': 'Ketorolac', 'description': 'one time dose of 30mg of IV Ketorolac at time of closure\n\nIntravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}, {'id': 'BG002', 'title': 'Dexamethasone', 'description': 'one time dose of 10mg of IV dexamethasone at the time of closure\n\nIntravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Collection was questionnaires, no analysis completed due to poor patient compliance regarding follow-up.', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Age data was not collected'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants per study arm', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline was less than desired due to closure of study because follow-up was poor.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-19', 'size': 90602, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-12T10:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Only patients will be masked from which cohort they were randomized into.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '25 patients into 3 separate arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'whyStopped': 'Poor compliance with data collection - too many intervals.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2020-11-12', 'resultsFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-20', 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Median Visual Analogue Scale for Neck Pain', 'timeFrame': 'one year', 'description': 'The Visual analogue scale is a line with numbers underneath it, with extremes marked "no pain" score of 0 (left) and the "worst pain imaginable" score of 10 (right).'}], 'primaryOutcomes': [{'measure': 'Percentage of Patients With Moderate/Severe Bazaz Classification', 'timeFrame': 'one year', 'description': 'The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation'}, {'measure': 'Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10)', 'timeFrame': 'one year', 'description': 'Percentage of patients with severe dysphagia based on the Eating Assessment Tool (EAT-10).Scores on the EAT-10 greater than 15 are indicative of severe dysphonia.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10).', 'timeFrame': 'one year', 'description': 'Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.'}, {'measure': 'Mean Neck Disability Index (NDI)', 'timeFrame': 'one year', 'description': 'The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury. There are 10 sections, and each section contains 6 statements.The statements are scored from 0 to 5, with 0 indicating no disability and 5 indicating complete disability.\n\n0: No disability or difficulty\n\n1. Mild disability or difficulty\n2. Moderate disability or difficulty\n3. Severe disability or difficulty\n4. Very severe disability or difficulty\n5. Complete disability or difficulty\n\nTotal Score: The scores from each of the 10 sections are summed to calculate the total score. The maximum possible score is 50, which would indicate severe disability, while a score of 0 indicates no disability.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysphagia', 'Dysphonia']}, 'descriptionModule': {'briefSummary': 'This study is to assess the efficacy of intra-operative intravenous non-steroidal anti-inflammatory drug (Ketorolac) versus intravenous (dexamethasone) administration on dysphagia and dysphonia after anterior cervical discectomy and fusion (ACDF).', 'detailedDescription': 'The purpose of this study is to assess the efficacy of two intra-operative, intravenous medications on dysphagia and dysphonia following anterior cervical discectomy and fusion (ACDF). The medications include Ketorolac, an anti-inflammatory versus dexamethasone, a corticosteroid. Eligibility criteria includes adults aged 19 years of age or older who are scheduled to undergo a ACDF for radiculopathy or myelopathy. Participants will be recruited for a prospective, randomized, single-blinded clinical drug study and randomized into three cohorts: (1) control (no steroid or non-steroidal anti-inflammatory (NSAID), (2) IV NSAID(1-time dose of 30mg of IV Ketorolac at time of closure), and (3) IV steroid (1-time dose of 10mg of IV dexamethasone at the time of closure. The primary outcome measures are patient questionnaires which include the EAT-10 and Bazaz classification for dysphagia and VHI-10 for dysphonia. In addition, the Neck Disability Index (NDI) and Visual Analogue Pain Scale (VAS) will also be collected. Research follow-up will be subject completed questionnaires to be collected pre-operatively and then post operation at day 1, 3 weeks, 6 weeks, 3 months, 6 months, and 1 year. Post operative questionnaires may be collected at time of patient follow-up in clinic, by phone or mail.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years of age and older\n* Undergoing anterior cervical discectomy and fusion (ACDF) for radiculopathy or myelopathy\n* No known allergies or sensitivities to steroid or non-steroidal medications\n\nExclusion Criteria:\n\n* Procedure is being done for revision, trauma, infection or tumor\n* Patients with known diagnosed metabolic diseases (diabetes, pancreatitis, gout, electrolyte imbalances, hypertension, hematological abnormalities including gastrointestinal bleeding...)\n* Patients with known kidney disease or a creatinine level above the upper limit of normal \\>1.27'}, 'identificationModule': {'nctId': 'NCT04650893', 'briefTitle': "The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF", 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'The Effect of Intravenous Non-steroidal Anti-inflammatory Drugs and Intravenous Corticosteroids on the Likelihood of Dysphagia and Dysphonia Following Anterior Cervical Discectomy and Fusion', 'orgStudyIdInfo': {'id': '0737-19-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'no steroid or non steroidal anti-inflammatory', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketorolac', 'description': 'one time dose of 30mg of IV Ketorolac at time of closure', 'interventionNames': ['Drug: Intravenous Ketorolac']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexamethasone', 'description': 'one time dose of 10mg of IV dexamethasone at the time of closure', 'interventionNames': ['Drug: Intravenous Dexamethasone']}], 'interventions': [{'name': 'Intravenous Ketorolac', 'type': 'DRUG', 'description': 'To assess the efficacy of the meds for dysphagia and dysphonia following ACDF', 'armGroupLabels': ['Ketorolac']}, {'name': 'Intravenous Dexamethasone', 'type': 'DRUG', 'description': 'To assess the efficacy of the meds for dysphagia and dysphonia following ACDF', 'armGroupLabels': ['dexamethasone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Control', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center, Lauritzen Outpatient Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Kevin Garvin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}