Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for
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
| Condition(s) | Post Operative Pain, Urolithiasis, Ureter Calculi, Stent Complication |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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 ure |
| Who can participate | 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 c |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Texas Southwestern Medical Center |
| Locations | Dallas, Texas, United States |
| Start date | 2025-03-01 |
| NCT ID | NCT06158620 |
| Official listing | https://clinicaltrials.gov/study/NCT06158620 |