Status:
RECRUITING
Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
assertio Therapeutics, Inc
Conditions:
Post Operative Pain
Urolithiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Objective: To improve quality-of-life and health care delivery to patients receiving ureteral stents. Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intr...
Detailed Description
Urinary stone disease (USD) leads to pain, diminished quality of life, missed work and school, chronic kidney disease, and renal failure.1-5 The prevalence of kidney stone disease in adults has risen ...
Eligibility Criteria
Inclusion
- ≥18 years old
- English-speaking
- Candidate for unilateral ureteroscopy for treatment of urolithiasis
- Surgical plan includes placement of a ureteral stent
Exclusion
- Pregnant/nursing, prisoners, cognitively impaired
- Solitary kidney
- Stone in transplant kidney
- Anatomic abnormalities (i.e., ureteral stricture, infundibular stenosis, uretero-pelvic junction obstruction, horseshoe kidney, duplicated system)
- History of ureteral reconstruction
- History of nephrocalcinosis, medullary sponge kidney, cystinuria
- Immobility or relative immobility
- Planned staged ureteroscopy
- History of ureteral stent complication or poor tolerance or a ureteral stent
- Urinary tract infection or sepsis
- Current anticoagulation use (81 mg Aspirin permissible)
- NSAID contraindication (acute renal failure or chronic kidney disease, bleeding disorders, allergic reaction to NSAIDs, ulcer disease, auto-immune disease)
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06158620
Start Date
March 1 2025
End Date
December 1 2026
Last Update
April 18 2025
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390