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The purpose of this research is to evaluate if corticosteroid (prednisone) after ureteroscopy and placement of the stent will help alleviate postoperative pain control in addition to other normal postoperative pain medications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care plus Corticosteroid | Experimental | Participants will receive standard of care postoperative ureteroscopy medication, with the addition of prednisone 25 mg. |
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| Standard of Care | Placebo Comparator | Participants will receive standard of care postoperative ureteroscopy medication, with the addition of a placebo pill. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid | Drug | In addition to the standard of care postoperative ureteroscopy medication, participants will be given prednisone 25 mg orally, once a day for 5 days post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale Pain Score | Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score. | Baseline, Day 1 (Post-operatively), Day 2, Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of times non-opioid analgesics medication used | Total number of times participants used non-opioid analgesics medication | 3 days |
| Cumulative usage of non-opioid analgesics medication | Total use of non-opioid analgesics medication of any kind, reported in mg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rev V. Vilasan Shylaja | Contact | 480-574-1466 |
| Name | Affiliation | Role |
|---|---|---|
| Karen L. Stern, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
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|
| Placebo | Other | In addition to the standard of care postoperative ureteroscopy medication, participants will be given a placebo pill orally, once a day for 5 days post-surgery. |
|
| 3 days |
| Change in Wisconsin Stone Quality of Life Questionnaire (WISQOL) score | The Wisconsin Stone Quality of Life (WISQOL) questionnaire is a 29 item survey that assesses quality of life for participants with kidney stones and covers four domains: social impact, emotional impact, stone-related symptom impact, and vitality. Questions are answered on a 5-point Likert scale, (1 = Very true, 5 = Not at all true), with a total maximum score of 140. Higher scores indicate a better quality of life. | Day 2 (Post-operatively), Day 3 |
| Change in Canadian Endourology Group Stent Symptom Score (CEGSSS) score | The Canadian Endourology Group Stent Symptom Score (CEGSSS) is a 11-item questionnaire that assesses ureteral stent symptoms through three domains: urination, pain, and quality of life. Scoring is based on participant responses to the individual questions, with higher scores indicating a greater symptom burden. | Day 1 (Post-operatively), Day 2, Day 3 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |