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NCT06158620 · ClinicalTrials.gov registry record · Phase 1
Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
A Phase 1 study of Post Operative Pain and Urolithiasis, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06158620 is a Phase 1 study of Post Operative Pain and Urolithiasis that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 80 participants, below the 235-participant average among 56 other Post Operative Pain trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06158620, a Phase 1 study of Post Operative Pain and Urolithiasis, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG intra-nasal ketorolac
- DRUG oral diclofenac
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-03-01 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06158620
The ClinicalTrials.gov registry entry for NCT06158620 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 235-participant average among 56 other Post Operative Pain trials with a reported enrollment target (66% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Post Operative Pain appearing as the primary indexed condition, and to 2 interventions - of which intra-nasal ketorolac is the first listed.
NCT06158620 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06158620 about?
NCT06158620 is a clinical study titled "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 tr...
What is the current status of trial NCT06158620?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2025-03-01. Estimated completion is 2026-12-01.
What conditions does trial NCT06158620 study?
This clinical trial studies the following conditions: Post Operative Pain, Urolithiasis, Ureter Calculi, Stent Complication.
What interventions are being tested in trial NCT06158620?
The interventions under investigation include: intra-nasal ketorolac (DRUG), oral diclofenac (DRUG).
Who is sponsoring clinical trial NCT06158620?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06158620 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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