RecruitingPhase 1/2

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

United States80 participantsStarted 2025-03-01

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1After my ureteroscopy for kidney stones, I'll need a ureteral stent — could you explain how this trial's intra-nasal ketorolac would be used to manage the pain that stent typically causes, and how it differs from what I'd normally be given?
2Since this is a Phase 1/2 trial, what does that mean for how much is already known about the safety and effectiveness of delivering ketorolac through the nose specifically for stent pain — and what risks should I be aware of?
3The trial is measuring my pain through three different questionnaires, like the USSQ and PROMIS surveys — how often would I need to fill those out, and is there a significant time or follow-up commitment involved that I should plan for after surgery?
4If I don't join this trial, what is the standard approach for managing ureteral stent pain after ureteroscopy, and is there a reason you'd recommend trying that first before considering an experimental option?
5Are there specific characteristics about my stone, my planned ureteroscopy, or my overall health that would make me a good or poor candidate for discussing this trial with you further?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pain scores as measured by USSQ Pain Survey

Timeframe: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)

Change in pain scores as measured by PROMIS questionnaire

Timeframe: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)

Change in pain scores as measured by Likert Scale Questionnaire

Timeframe: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)

Trial details

NCT IDNCT06158620

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-01

Contact for this trial

Brett Johnson, MD

214/645-8765 brett.johnson@utsouthwestern.edu

View on ClinicalTrials.gov More Post Operative Pain trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in pain scores as measured by USSQ Pain Survey

Timeframe: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)

Change in pain scores as measured by PROMIS questionnaire

Timeframe: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)

Change in pain scores as measured by Likert Scale Questionnaire

Timeframe: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)