Using intra-nasal ketorolac to relieve pain from ureteral stents after ureteroscopy
Official title: Intra-nasal Ketorolac Versus Oral Diclofenac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
Run by University of Texas Southwestern Medical Center · NCT06158620 · Data updated 2026-11-12
This study is testing whether a nasal spray of ketorolac can help relieve pain better than oral diclofenac for patients with ureteral stents after surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | April 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT06158620 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are English-speaking and scheduled for unilateral ureteroscopy with ureteral stent placement for urolithiasis.
✕Probably not a fit
Patients who are pregnant, have a solitary kidney, or have certain anatomical abnormalities or contraindications to NSAIDs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to improve the quality of life for patients with ureteral stents by evaluating the effectiveness of intra-nasal ketorolac compared to oral diclofenac for managing post-operative pain. Initially, the feasibility and qualitative outcomes of intra-nasal ketorolac will be assessed in patients with indwelling ureteral stents. Following this, a randomized trial will compare pain relief and the rate of unplanned clinical encounters between the two medications. The study is motivated by the need for effective pain management alternatives to opioids in patients experiencing discomfort from ureteral stents after ureteroscopy for urolithiasis.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve the overall experience for patients with ureteral stents.
How similar studies have gone: Previous studies have shown that non-oral formulations of ketorolac can effectively manage acute pain, suggesting potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years old * English-speaking * Candidate for unilateral ureteroscopy for treatment of urolithiasis * Surgical plan includes placement of a ureteral stent Exclusion Criteria: * 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's running
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UT Southwestern Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Brett Johnson, MD — University of Texas Southwestern Medical Center
- Study coordinator: Brett Johnson, MD
- Email: brett.johnson@utsouthwestern.edu
- Phone: 214/645-8765
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.