NCT06158620 Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
| NCT ID | NCT06158620 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Post Operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-03-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Brett Johnson, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06158620 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06158620 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06158620 currently recruiting?
Yes, NCT06158620 is actively recruiting participants. Contact the research team at brett.johnson@utsouthwestern.edu for enrollment information.
Where is the NCT06158620 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06158620 clinical trial?
NCT06158620 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Brett Johnson, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 80 participants.