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A double blind randomized controlled trial designed to compare pain control and safety with ketorolac and oxycodone in the post-operative setting for patients undergoing ureteroscopy for treatment of urinary stones. Patients are followed for five days after their surgery as they record their pain scores, medication utilization, and stent related symptoms.
Pain is the leading cause for unplanned emergency department visits and readmissions after ureteroscopy (URS), making post-operative analgesic stewardship a priority given the current opioid epidemic. The investigators conducted a double-blinded, randomized controlled trial (RCT), with non-inferiority design, comparing nonsteroidal anti-inflammatory drugs (NSAIDs) to opiates for postoperative pain control in patients undergoing URS for urolithiasis.
Patients were randomized and blinded to either oxycodone (5mg) or ketorolac (10mg), taken as needed, with 3 non-blinded oxycodone rescue pills for breakthrough pain. Primary study outcome was visual analog scale pain score on post-operative days 1-5. Secondary outcomes included medication utilization, side effects, and Ureteral Stent Symptoms Questionnaire (USSQ) scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone group | Active Comparator | Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy. |
|
| Ketorolac group | Experimental | Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | 5 mg of oxycodone taken by mouth every 6 hours for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Pain Score | Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Pills Used | the use of opioid medication as per the study protocol; Required study pills | Post-operative days 1 to 5 |
| Use of Rescue Medication (Opioid) | the use of rescue opioid medication as per the study protocol; use of rescue medication by the patients |
| Measure | Description | Time Frame |
|---|---|---|
| Day in Bed | number of days patient spent confined to bed post operatively | 5 days |
| Visual Analogue Scale (VAS) | VAS as reported by the patients while in PACU (score from 0-10, with 0 meaning no pain and 10 max pain) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sriharan Sivalingam, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxycodone Group | Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy. Oxycodone: 5 mg of oxycodone taken by mouth every 6 hours for 5 days |
| FG001 | Ketorolac Group | Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy. Ketorolac: 10 mg of ketorolac taken by mouth every 6 hours for 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxycodone Group | Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy. Oxycodone: 5 mg of oxycodone taken by mouth every 6 hours for 5 days |
| BG001 | Ketorolac Group |
| 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 | Visual Analog Pain Score | Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain. | Posted | Mean | Standard Deviation | units on a scale | 5 days |
|
the side effects have been reported over the study period of 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 | Oxycodone Group | Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy. Oxycodone: 5 mg of oxycodone taken by mouth every 6 hours for 5 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment | patient felt nausea and impending vomiting |
This study has limitations: medication adherence and symptom scores relied on self-reporting; some patients had early stent removal or were lost to follow-up; the population excluded sicker patients; and most were Caucasian at a tertiary center, limiting generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sriharan Sivalingam | Cleveland Clinic foundation | 2162130159 | SIVALIS@ccf.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 | Nov 29, 2018 | Mar 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D014514 | Ureteral Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Ketorolac |
| Drug |
10 mg of ketorolac taken by mouth every 6 hours for 5 days |
|
|
| post operative day 1-5 |
| Up to 5 days |
Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy.
Ketorolac: 10 mg of ketorolac taken by mouth every 6 hours for 5 days
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Study Pills Used | the use of opioid medication as per the study protocol; Required study pills | 5 patients in the Oxy group and 2 in the Ketorolac group didn't require meds so they were excluded from final calculation | Posted | Mean | Standard Deviation | number of pills used | Post-operative days 1 to 5 |
|
|
|
| Secondary | Use of Rescue Medication (Opioid) | the use of rescue opioid medication as per the study protocol; use of rescue medication by the patients | not all enrolled subjects used rescue medications | Posted | Mean | Standard Deviation | number of pills used | post operative day 1-5 |
|
|
|
| Other Pre-specified | Day in Bed | number of days patient spent confined to bed post operatively | Posted | Mean | Standard Deviation | days | 5 days |
|
|
|
| Other Pre-specified | Visual Analogue Scale (VAS) | VAS as reported by the patients while in PACU (score from 0-10, with 0 meaning no pain and 10 max pain) | Posted | Mean | Standard Deviation | units on a scale | Up to 5 days |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 12 |
| 43 |
| EG001 | Ketorolac Group | Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy. Ketorolac: 10 mg of ketorolac taken by mouth every 6 hours for 5 days | 0 | 38 | 0 | 38 | 11 | 38 |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment | patient who had actual vomiting as a medication side effect |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |