Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.
This is a randomized control trial comparing oral ketorolac (10mg, Q6 PRN) and oxycodone (5mg, Q6 PRN) medication for the use of post-operative analgesia after kidney stone removal surgery called percutaneous nephrolithotomy (PCNL). Primary endpoints are visual analog pain scores (VAS) for days 1-5 and day 10 post operatively. Secondary endpoints are pill counts, patient-related outcome survey (PROMIS) scores, emergency room visits, and patient telephone calls. 90 subjects will be enrolled, with 45 in each group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid group | Active Comparator | Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively. |
|
| NSAID | Active Comparator | Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5mg Oxycodone, Q6 PRN | Drug | Oxycodone is an opioid that is used to relieve moderate to severe pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Scores | Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded | post-op day 5 and post-op day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Pill Count | A pill count will be conducted of each prescribed postoperative medication. | post-op at day 10 |
| Number of Participants Who Called the Office | Number of participants with pain related calls to the office recorded. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant women
History of chronic opioid abuse
Allergy, hypersensitivity, or other contraindication to NSAID usage such as
eGFR < 60 mL/min
Peptic ulcer disease or history of gastric bypass
Concurrent use of antiplatelet or anticoagulation therapy (including aspirin)
Thrombocytopenia
Suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding.
Concomitant medications:
Allergy, hypersensitivity, or other contraindication to opioids:
Current opioid prescription/usage for any reason, including active treatment with suboxone or methadone
Respiratory depression
Patients with acute or severe bronchial asthma or hypercarbia
Patients who have or is suspected of having paralytic ileus as PCNL done under general anesthesia
Patients with hepatic Impairment
Concomitant medications:
Diagnosis of chronic pain disorder
Reduced sensation of abdomen or pelvis (e.g. patients with spinal cord injury)
Pre-existing stent or nephrostomy tube
Urinary tract anomalies such as urinary diversion, horseshoe kidney, solitary kidney, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum)
Pulmonary disease
Liver disease
Seizure disorders
Subjects taking nephrotoxic medications
Subjects taking medications that can increase sedation risk (benzodiazepines or other sedative hypnotics)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mantu Gupta, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | New York | New York | 10019 | United States |
Only aggregate data will be shared
Not provided
Not provided
Not provided
Not provided
Not provided
Participants enrolled from 5-19-2023 to 12-26-2024
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Opioid Group | Patients prescribed 5mg Oxycodone, Q6 as needed (PRN) postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain. |
| FG001 | NSAID | Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively. 10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Opioid Group | Patients prescribed 5mg Oxycodone, Q6 PRN postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain. |
| BG001 | NSAID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Scale (VAS) Pain Scores | Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded | Posted | Median | Inter-Quartile Range | score on a scale | post-op day 5 and post-op day 10 |
|
up to 10 days post-op
There were no adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Opioid Group | Patients prescribed 5mg Oxycodone, Q6 PRN postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mantu Gupta | Icahn School of Medicine at Mount Sinai | (212) 241-1272 | Mantu.Gupta@mountsinai.org |
Not provided
| 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 | Apr 9, 2024 | Mar 11, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2024 | Jan 27, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Operating surgeon will be blinded to treatment arm intraoperatively (will not be blinded postoperatively)
| 10mg Ketorolac, Q6 PRN | Drug | Ketorolac is an NSAID used to relieve moderately severe pain. |
|
| post-op up to day 10 |
| Number of Participants With Pain Related Visits | Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded. | post-op up to day 10 |
| Patient-related Outcome Survey (PROMIS) Scores | Patients given a survey containing questions from Patient-related outcome survey (PROMIS) instruments. A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. | post-op at day 10 |
Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively.
10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m^2 |
|
|
|
| Secondary | Pill Count | A pill count will be conducted of each prescribed postoperative medication. | Posted | Mean | Standard Deviation | pills | post-op at day 10 |
|
|
|
| Secondary | Number of Participants Who Called the Office | Number of participants with pain related calls to the office recorded. | Posted | Count of Participants | Participants | post-op up to day 10 |
|
|
|
| Secondary | Number of Participants With Pain Related Visits | Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded. | Posted | Count of Participants | Participants | post-op up to day 10 |
|
|
|
| Secondary | Patient-related Outcome Survey (PROMIS) Scores | Patients given a survey containing questions from Patient-related outcome survey (PROMIS) instruments. A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. | Posted | Median | Inter-Quartile Range | T-score | post-op at day 10 |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | NSAID | Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively. 10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain. | 0 | 42 | 0 | 42 | 0 | 42 |
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital 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 |