Recruiting
Phase 1
Phase 2

Ketorolac

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06158620

Conditions

Post Operative Pain

Urolithiasis

Ureter Calculi

Stent Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

intra-nasal ketorolac

oral diclofenac

Study Details

Brief 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.

Conditions

Post Operative Pain

Urolithiasis

Ureter Calculi

Stent Complication

Study ID

NCT06158620

Start date

Mar 1, 2025

Status verified date

May, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sprix

Phase I will consist of a single-arm open label pilot study. Prior to the initiation of a large-scale randomized trial, we propose a single-arm open label pilot study to evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents. We seek to enroll 20 patients for the initial pilot.

Phase II will consist of a randomized trial comparing intranasal ketorolac to Diclofenac, a commonly used oral NSAID. , Diclofenac potassium. Following ureteroscopy and stent placement, patients will receive standard of care medications to mitigate post operative pain and stent discomfort, and will be randomized to receive either as needed intra-nasal ketorolac or oral diclofenac. We seek to enroll and randomize 60 patients in a 1:1 fashion. Analysis will be intention to treat.

active comparator: Diclofenac

Phase II will consist of a randomized trial comparing intranasal ketorolac to Diclofenac, a commonly used oral NSAID. , Diclofenac potassium. Following ureteroscopy and stent placement, patients will receive standard of care medications to mitigate post operative pain and stent discomfort, and will be randomized to receive either as needed intra-nasal ketorolac or oral diclofenac. We seek to enroll and randomize 60 patients in a 1:1 fashion. Analysis will be intention to treat.

Interventions

intra-nasal ketorolac

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

oral diclofenac

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

Primary outcome measure

  • Change in pain scores as measured by USSQ Pain Survey [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10) ]

Central Contacts and Locations

Central contacts

Brett Johnson, MD

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

Isaac Palma-Zamora, MD

214/645-8765isaac.palma-zamora@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

May 27, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-05-27.