What is this study trying to find out about pain after ureteral stent placement?

This study is evaluating how well intra-nasal ketorolac works compared to oral diclofenac to relieve pain and discomfort from ureteral stents after kidney stone surgery. It aims to improve patient quality of life and reduce unexpected medical visits. The study is sponsored by the University of Texas Southwestern Medical Center.

Who may be eligible for this post-operative pain clinical trial?

Adults 18 years and older who speak English and are candidates for unilateral ureteroscopy with planned ureteral stent placement may be eligible. People with certain kidney abnormalities, infections, or conditions preventing NSAID use are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this post-operative pain clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, participants may have personal travel expenses that are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06158620

Study of Intra-nasal Ketorolac Compared to Oral Diclofenac for Pain from Ureteral Stents After Ureteroscopy for Kidney Stones

Led by University of Texas Southwestern Medical Center · Updated on 2026-05-27

Participants Needed

Research Sites

34 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are exploring ways to improve quality of life and health care delivery for patients who have ureteral stents after surgery to remove kidney stones. The study focuses on comparing two pain relief options intra-nasal ketorolac and oral diclofenac, both non-steroidal anti-inflammatory drugs NSAIDs. This research includes a Phase I pilot and a Phase II randomized trial to understand pain control and reduce unplanned medical visits related to stent discomfort. The study begins with a Phase I single-arm pilot involving 20 patients using intra-nasal ketorolac to assess feasibility and patient experiences. In Phase II, 60 patients will be randomly assigned to receive either intra-nasal ketorolac or oral diclofenac in addition to standard care after ureteroscopy and stent placement. Both treatments are given as needed to manage post-operative pain and discomfort caused by the ureteral stent. Participants will complete pain assessments before surgery and on the day of stent removal, using multiple pain measurement tools. Researchers will track changes in pain scores and the number of unplanned clinical visits due to stent-related symptoms. The study will also monitor the practicality and patient feedback on intra-nasal ketorolac use, with follow-up focused on outcomes between postoperative day 5 and 10, lasting until the stent is removed.

CONDITIONS

Brief Title

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Intra-nasal ketorolac (Sprix)	Oral diclofenac
What it is	A non-steroidal anti-inflammatory drug (NSAID) delivered by nasal spray, studied for treating pain after ureteroscopy and stent placement.	An oral NSAID commonly used for pain relief, given as an active comparator for stent-related pain after ureteroscopy.
Role in the trial	Investigational arm testing the efficacy and tolerability of intranasal ketorolac for acute stent-associated pain after stone surgery.	Comparator arm receiving standard oral diclofenac for the same post-surgical indication.
Primary use	To reduce pain and discomfort associated with ureteral stent placement after ureteroscopy for kidney stones.	To manage pain following ureteral stent insertion as established clinical practice.
How it is given	Given as a nasal spray (intra-nasal) by the patient after ureteroscopy and during the indwelling stent period.	Administered by mouth (oral tablets) during the stent period after the surgical procedure.
Evidence status	Recent studies support intranasal ketorolac as effective for reducing acute post-operative pain, but results for patients after ureteral stent placement are not yet established.	Oral diclofenac is backed by clinical guidelines and research as an effective NSAID for pain control in stone surgery and stent-related discomfort.
Important limitations	Not all patients can use NSAIDs due to contraindications such as kidney disease, bleeding risk, or allergy. Results for this exact indication are not yet available.	Oral NSAIDs like diclofenac may be unsuitable for patients with kidney disease, peptic ulcers, or allergies; gastrointestinal and renal side effects are possible.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

18 years old or older
English-speaking
Candidate for unilateral ureteroscopy to treat urolithiasis
Surgical plan includes placement of a ureteral stent

You will not qualify if you...

Pregnant or nursing women
Prisoners
Cognitively impaired individuals
Solitary kidney
Stone in transplant kidney
Anatomic abnormalities such as ureteral stricture, infundibular stenosis, uretero-pelvic junction obstruction, horseshoe kidney, or duplicated system
History of ureteral reconstruction
History of nephrocalcinosis, medullary sponge kidney, or cystinuria
Immobility or relative immobility
Planned staged ureteroscopy
History of ureteral stent complication or poor tolerance
Urinary tract infection or sepsis
Current use of anticoagulation medications (81 mg Aspirin allowed)
Contraindication to NSAIDs including acute renal failure, chronic kidney disease, bleeding disorders, allergic reaction to NSAIDs, ulcer disease, or auto-immune disease

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From day of ureteroscopy through post-operative day 5 to 10 until ureter stent removal

Participants receive either intra-nasal ketorolac or oral diclofenac to manage post-operative pain and ureteral stent discomfort following ureteroscopy.

Baseline visit before surgery and 1 visit for stent removal