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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery |
|
| Ketorolac | Experimental | Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Oral ketorolac for pain control following ACL reconstruction surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Visual Analogue Scale Scores | Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level. | Up to 8 weeks postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Medication | Number of oxycodone-acetaminophen tablets | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Karns, MD | University Hospital Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36476466 | Derived | Mengers SR, Strony JT, Sivasundaram L, Yu J, Goodfellow D, Salata MJ, Voos JE, Karns MR. Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control After Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective, Randomized Controlled Study. J Am Acad Orthop Surg. 2022 Dec 15;30(24):e1580-e1590. doi: 10.5435/JAAOS-D-21-00721. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control |
| FG001 | Ketorolac | Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control |
| BG001 | Ketorolac |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Analogue Scale Scores | Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level. | Posted | Mean | Standard Error | score on a scale | Up to 8 weeks postoperative |
|
6 weeks
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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 | Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea/ vomitin | Gastrointestinal disorders | Systematic Assessment |
This is a single-institution study involving only five surgeons, so patient demographics and outcomes may not reflect a broader population. Neither surgeons nor patients were blinded with regards to medication use. Therefore, subjective pain scores may have been influenced by perceptions of greater pain control in patients who received ketorolac in addition to oxycodone-acetaminophen. The study may be underpowered with regards to functional outcome scores and medication side effects profiles.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Karns | UH Cleveland Medical Center | 216-844-7200 | srmengers@gmail.com |
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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 | May 9, 2019 | Sep 13, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2019 | Sep 13, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Oxycodone-Acetaminophen |
| Drug |
Oral oxycodone-acetaminophen for post-operative pain control |
|
Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control
Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoker | Count of Participants | Participants |
|
|
|
| Secondary | Narcotic Medication | Number of oxycodone-acetaminophen tablets | Posted | Mean | Standard Error | tablets | 5 days |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 26 |
| 26 |
| EG001 | Ketorolac | Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery | 0 | 22 | 0 | 22 | 22 | 22 |
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| bleeding | Vascular disorders | Systematic Assessment |
|
| dizzy | Nervous system disorders | Systematic Assessment |
|
| drowsy | Nervous system disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |