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Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
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.
Details
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | PHASE1, PHASE2 |
| Status | RECRUITING |
| Enrolment | 80 |
| Start date | Sat Mar 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Dec 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Post Operative Pain
- Urolithiasis
- Ureter Calculi
- Stent Complication
Interventions
- intra-nasal ketorolac
- oral diclofenac
Countries
United States