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The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Experimental | 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. |
|
| Placebo | Placebo Comparator | 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain 'Right Now' | Visual analog scale score for pain on a scale from 0 = None to 10 = Worst. | 24 hours after the end of surgery |
| Morphine Equivalents of Concomitant Pain Medication | The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient. | 24 hours after the end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell R. Humphreys, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24976224 | Derived | Grimsby GM, Andrews PE, Castle EP, Nunez R, Mihalik LA, Chang YH, Humphreys MR. Long-term renal function after donor nephrectomy: secondary follow-up analysis of the randomized trial of ketorolac vs placebo. Urology. 2014 Jul;84(1):78-81. doi: 10.1016/j.urology.2014.04.009. | |
| 23058854 | Derived | Grimsby GM, Conley SP, Trentman TL, Castle EP, Andrews PE, Mihalik LA, Hentz JG, Humphreys MR. A double-blind randomized controlled trial of continuous intravenous Ketorolac vs placebo for adjuvant pain control after renal surgery. Mayo Clin Proc. 2012 Nov;87(11):1089-97. doi: 10.1016/j.mayocp.2012.07.018. Epub 2012 Oct 8. |
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Patients were recruited from October 2008 to November 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac | 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. |
| FG001 | Placebo | 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac | 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. |
| BG001 | Placebo | 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. |
| 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 | Pain 'Right Now' | Visual analog scale score for pain on a scale from 0 = None to 10 = Worst. | Posted | Mean | Standard Deviation | units on a scale | 24 hours after the end of surgery |
|
Adverse events were noted during hospitalization (approximately 4 days).
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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 | Ketorolac | 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell R. Humphreys MD | Mayo Clinic | 480-301-8000 | humphreys.mitchell@mayo.edu |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Morphine Equivalents of Concomitant Pain Medication | The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient. | Posted | Mean | Standard Deviation | mg | 24 hours after the end of surgery |
|
|
|
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | Placebo | 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. | 0 | 9 | 8 | 9 |
| Hypochloraemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
|
| Blood Urea Nitrogen Increased | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
|
| Nonprotein Nitrogen Increased | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
|
| Leucopenia | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
|
| Monocytopenia | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
|
| Hyperchloraemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
|
| Lymphadenopathy Cervical | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
|
| Hypocapnia | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
|
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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 |
| D006571 | Heterocyclic Compounds |