A Phase 1/2 interventional study of intra-nasal ketorolac and oral diclofenac in Post Operative Pain, Urolithiasis and Ureter Calculi, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by University of Texas Southwestern Medical Center · Phase 1/2, Interventional, and Treatment
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.
Urinary stone disease (USD) leads to pain, diminished quality of life, missed work and school, chronic kidney disease, and renal failure.1-5 The prevalence of kidney stone disease in adults has risen to almost 9% as of 2010 in the United States (US). The 5-year recurrence rate without treatment is 53%.6,7 Increasing utilization of a ureteroscopic approach to treat urolithiasis has led to an increased proportion of stone patients undergoing ureteral stent placement.
In the US, approximately 90% of patients receive a ureteral stent following ureteroscopy. Some patients that undergo ureteral stent placement experience significant and debilitating symptoms of urinary urgency, frequency, suprapubic and flank pain, and incontinence. Treatment of these symptoms has historically relied heavily on opioid pain medications. However, recent emphasis on risk associated with opioid medications has reduced their use, and paved the way for alternative approaches. As such, non-steroidal anti-inflammatory drugs (NSAIDs) have become an integral part of multimodal techniques at mitigating post operative pain and associated ureter stent discomfort.
Ketorolac, an NSAID, can be used in the management of acute pain related to ureteral obstruction, renal colic, and indwelling ureter stent. There are four available formulations of ketorolac: oral, intra-muscular (IM), intra-nasal (IN), and intravenous (IV). Non-oral formulations are known to have faster onset of action and an earlier peak analgesic effect.8 As opposed to injectable (IM or IV) ketorolac that needs to be administered by a clinical provider, IN ketorolac may conveniently be self-administered.9 Furthermore, the favorable pharmacokinetics of IN ketorolac allow for its significant efficacy in providing timely pain relief without the need of opioid medications. However, one of the significant barriers of intra-nasal ketorolac is the cost. An intra-nasal course can cause upwards of $1500 compared to $20 of oral ketorolac.
Ketorolac prevents unplanned renal colic-related clinical encounters post stent removal.10 Study team recently published the study team's results from a randomized trial comparing intramuscular injection of ketorolac to placebo at the time ureteral stent removal reduced the incidence of unplanned clinic returns or emergency room visits. While this trial was aimed at the small number of patients that develop severe ureteral colic following stent removal, investigators feel ketorolac's strong anti-inflammatory properties can be leveraged to mitigate acute indwelling ureteral stent symptoms.
While it is not feasible to treat every stent patient empirically with IN ketorolac, there may be an identifiable subset of patients that may benefit from this formulation. Its favorable pharmacokinetics allow for its significant efficacy in providing timely pain relief without the need of opioid medications. This makes IN ketorolac an intriguing option that may decrease unplanned clinical encounters related to indwelling ureter stent discomfort. Especially when the cost of a post-operative emergency room visits which can include laboratory testing, computed tomography, IV medication and possible admission can dwarf the cost of IN ketorolac.
Furthermore, a recent qualitative analysis published by Harper et al in the in the STudy to Enhance uNderstanding of sTent-associated Symptoms (STENTS) study reveal a highly variable patient experience with stents.11 For some, the negative experience of the stent can be life altering. Therefore, there is a critical need to improve the pain and quality of life of those requiring ureteral stenting. Ideally, this can be done in a directed way to offer more relief to those patients most at risk for severe symptoms.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 80 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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Exclusion Criteria:
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Contraindication
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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.
Drug: intra-nasal ketorolac
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.
Drug: oral diclofenac
Experimental group receiving intra-nasal ketorolac for management of post-operative pain following ureteroscopy for kidney stone, and associated ureter stent discomfort.
Also known as: Sprix
Control group to receive oral diclofenac, which is a comparable medication to intra-nasal ketorolac.
Change in pain scores as measured by USSQ Pain Survey
Associated pain burden will be measured using standardized Ureteral Stent Symptom Questionnaire (USSQ) Pain Survey. Possible scores range from 0-10, where lower scores indicate better outcome.
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
Associated pain burden will be measured using standardized Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity and Interference questionnaire. Possible scores range from 0-10, where lower scores indicate better outcome.
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
Associated pain burden will be measured using standardized Likert Scale Questionnaire. Possible scores range from 0-10, where lower scores indicate better outcome. For those patients in the SPIRIX arm, they will be asked to complete the Likert Scale Questionnaire approximately 30 minutes after taking each SPIRIX dose.
Time frame: Baseline (before surgery in the pre-operative setting -Day 0), the day of ureter stent removal (Post-operative day 5 through 10)
Number of unplanned clinical encounters
number of clinical encounters (i.e. telephone calls, MyChart messages, emergency room visits, hospital readmissions) related to ureter stent discomfort will be counted.
Time frame: Post-operative setting -the day of ureter stent removal (Post-operative day 5 through 10)
Plan to share: No
Started Mar 2025 (actual). Primary completion is estimated for Apr 2027, 25 months after the start.
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Studies of the drug tested here: Ketorolac Tromethamine
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