Actively Recruiting
Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
Led by University of Texas Southwestern Medical Center · Updated on 2025-04-18
80
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
A
assertio Therapeutics, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 intra-nasal ketorolac in patients with indwelling ureteral stents (Phase I), followed by a randomized trial comparing two non-steroidal anti-inflammatory drugs, intra-nasal Ketorolac versus oral Diclofenac. Hypotheses: Due to its favorable pharmacokinetics in relieving acute pain, investigators expect improved pain scores and a lower rate of unplanned clinical encounters in patients receiving intra-nasal ketorolac compared to those taking oral diclofenac following ureteroscopic surgery for urolithiasis. Study Rationale: Following ureteroscopic management of urolithiasis, patient with indwelling ureter stents have higher levels of discomfort compared to those without a ureter stent. Prior studies showed that intramuscular Ketorolac at time of ureter stent removal decreased the incidence of unplanned clinical encounters. Furthermore, onset of analgesic effect by intra-nasal ketorolac is faster than its oral form, and similar its intramuscular and intravenous counterparts.
CONDITIONS
Official Title
Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- English speaking
- Candidate for unilateral ureteroscopy to treat urolithiasis
- Surgical plan includes placement of a ureteral stent
You will not qualify if you...
- Pregnant or nursing
- Prisoners
- Cognitively impaired
- Solitary kidney
- Stone in transplant kidney
- Anatomic abnormalities including ureteral stricture, infundibular stenosis, uretero-pelvic junction obstruction, horseshoe kidney, or duplicated system
- History of ureteral reconstruction
- History of nephrocalcinosis, medullary sponge kidney, or cystinuria
- Immobility or relative immobility
- Planned staged ureteroscopy
- History of ureteral stent complications or poor tolerance
- Urinary tract infection or sepsis
- Current anticoagulation use (except 81 mg aspirin)
- Contraindications to NSAIDs such as acute renal failure, chronic kidney disease, bleeding disorders, allergy to NSAIDs, ulcer disease, or autoimmune disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
B
Brett Johnson, MD
CONTACT
I
Isaac Palma-Zamora, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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