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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: assertio Therapeutics, Inc
• Treatments: Diclofenac; Ketorolac

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)