Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease

Recruiting now · Phase 1/Phase 2

Conditions studied: Post Operative Pain, Urolithiasis, Ureter Calculi, Stent Complication

In brief

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.

Key facts

Study ID

NCT06158620

Run by

University of Texas Southwestern Medical Center

People needed

80

Starts

2025-03-01

Expected to finish

2027-12-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years old
• English-speaking
• Candidate for unilateral ureteroscopy for treatment of urolithiasis
• Surgical plan includes placement of a ureteral stent

You may not qualify if…

• 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)

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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