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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Ketorolac | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Oral Ketorolac |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Visual Analog Scale Scores | The Visual Analog Scale ranges from a minimum score of 0 to a maximum score of 100. A smaller score would be considered a better outcome. | participants were assessed at one single time point up to 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Retear of Rotator Cuff Repair | Assessing retear of rotator cuff repair on postop MRI. | 6 months |
Not provided
Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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44 patients were enrolled/randomized but only 39 patients were included for final analysis because of incomplete data collection
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control: no ketorolac |
| FG001 | Ketorolac | Ketorolac: Oral Ketorolac |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
44 patients were enrolled/randomized but only 39 patients were included for final analysis because of incomplete data collection
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control: no ketorolac |
| BG001 | Ketorolac | Ketorolac: Oral Ketorolac |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Postoperative Visual Analog Scale Scores | The Visual Analog Scale ranges from a minimum score of 0 to a maximum score of 100. A smaller score would be considered a better outcome. | Posted | Median | Inter-Quartile Range | score/units on a scale | participants were assessed at one single time point up to 8 weeks. |
|
|
14 months
The time frame that is expressed is that over which each participant was assessed
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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 ketorolac | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Nausea/Vomiting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Strony, MD | University Hospitals Cleveland Medical Center | 908-268-3663 | john.strony@uhhospitals.org |
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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 | Feb 19, 2019 | Oct 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoker | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Retear of Rotator Cuff Repair | Assessing retear of rotator cuff repair on postop MRI. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 19 |
| 0 |
| 19 |
| 16 |
| 19 |
| EG001 | Ketorolac | Ketorolac: Oral Ketorolac | 0 | 20 | 0 | 20 | 9 | 20 |
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Itching | Immune system disorders | Non-systematic Assessment |
|
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| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |