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Poor compliance with data collection - too many intervals.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | no steroid or non steroidal anti-inflammatory |
|
| Ketorolac | Active Comparator | one time dose of 30mg of IV Ketorolac at time of closure |
|
| dexamethasone | Active Comparator | one time dose of 10mg of IV dexamethasone at the time of closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Ketorolac | Drug | To assess the efficacy of the meds for dysphagia and dysphonia following ACDF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Moderate/Severe Bazaz Classification | The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation | one year |
| Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | 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. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia. | one year |
| Mean Neck Disability Index (NDI) |
| Measure | Description | Time Frame |
|---|---|---|
| Median Visual Analogue Scale for Neck Pain | 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). | one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Garvin, MD | University of Nebraska | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center, Lauritzen Outpatient Center | Omaha | Nebraska | 68105 | United States |
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Study was terminated early, lack of compliance for follow-up intervals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | no steroid or non steroidal anti-inflammatory Placebo: Control |
| FG001 | Ketorolac | one time dose of 30mg of IV Ketorolac at time of closure Intravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following anterior cervical discectomy and fusion (ACDF). |
| FG002 | Dexamethasone | one time dose of 10mg of IV dexamethasone at the time of closure Intravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline was less than desired due to closure of study because follow-up was poor.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | no steroid or non steroidal anti-inflammatory Placebo: Control |
| BG001 | Ketorolac | one time dose of 30mg of IV Ketorolac at time of closure Intravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Collection was questionnaires, no analysis completed due to poor patient compliance regarding follow-up. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Moderate/Severe Bazaz Classification | The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation | Posted | Number | percentage of participants | one year |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | no steroid or non steroidal anti-inflammatory Placebo: Control | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Danielson | University of Nebraska Medical Center | 402-559-1703 | peter.danielson@unmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2023 | Dec 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D055154 | Dysphonia |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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25 patients into 3 separate arms.
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Only patients will be masked from which cohort they were randomized into.
| Intravenous Dexamethasone | Drug | To assess the efficacy of the meds for dysphagia and dysphonia following ACDF |
|
| Placebo | Drug | Control |
|
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.
0: No disability or difficulty
Total 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.
| one year |
| BG002 | Dexamethasone | one time dose of 10mg of IV dexamethasone at the time of closure Intravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF |
| BG003 | Total | Total of all reporting groups |
Age data was not collected |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of participants per study arm | Count of Participants | Participants |
|
one time dose of 10mg of IV dexamethasone at the time of closure Intravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF |
|
|
| Primary | Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | 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. | Posted | Number | percentage of participants | one year |
|
|
|
| Secondary | Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia. | No placeholder numbers included; only one participant completed study. | Posted | Number | percentage of participants | one year |
|
|
|
| Secondary | Mean Neck Disability Index (NDI) | 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. 0: No disability or difficulty
Total 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. | Posted | Mean | Full Range | score on a scale | one year |
|
|
|
| Other Pre-specified | Median Visual Analogue Scale for Neck Pain | 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). | Posted | Mean | Full Range | score on a scale | one year |
|
|
|
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Ketorolac | one time dose of 30mg of IV Ketorolac at time of closure Intravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Dexamethasone | one time dose of 10mg of IV dexamethasone at the time of closure Intravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF | 0 | 12 | 0 | 12 | 0 | 12 |
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| D010038 | Otorhinolaryngologic Diseases |
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|