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A Prospective, Randomized, Pilot Study of Preoperative Anti-Inflammatory Therapy for Ureteral Stent Symptoms
This is a pilot study to (1) evaluate the effect of Ketorolac on inflammatory response and its impact on stent related symptoms in patients undergoing stent placement procedure and (2) assess feasibility of recruitment, randomization, assessment procedures and implementation of the study intervention.
Details
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | RECRUITING |
| Enrolment | 36 |
| Start date | 2018-07-31 |
| Completion | 2027-10 |
Conditions
- Ureteral Stent Placement
- Kidney Stone
Interventions
- Ketorolac Trometamol 30Mg/1mL Injection
- Normal saline
Primary outcomes
- Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1 — Stent insertion Day 1
The Analog Pain Scale is a patient reported scale from 0-10 that will be administered after standard surgical procedure of ureteroscopy with or without laser lithotripsy and/or stone extraction). The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain. - Analog Pain Scale, 0 - 10 rating of pain - Stent removal — Stent removal visit (Approximately 7 to 14 days)
The Analog Pain Scale is a patient reported scale from 0-10 that will be administered during the stent removal visit. The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain. - Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit — 1 to 2 months post stent removal
The Analog Pain Scale is a patient reported scale from 0-10 that will be administered during follow up visit. The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
Countries
United States