RecruitingPhase 1Phase 2NCT06158620

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

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


Sponsor

University of Texas Southwestern Medical Center

Enrollment

80 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria12

  • 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)

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Interventions

DRUGintra-nasal ketorolac

Experimental group receiving intra-nasal ketorolac for management of post-operative pain following ureteroscopy for kidney stone, and associated ureter stent discomfort.

DRUGoral diclofenac

Control group to receive oral diclofenac, which is a comparable medication to intra-nasal ketorolac.


Locations(1)

UT Southwestern Medical Center

Dallas, Texas, United States

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NCT06158620


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