[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528273":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":61,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":31,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":31,"enrollmentInfo":77,"targetDuration":31,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":31,"overallStatus":47,"whyStopped":31,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sprix","EXPERIMENTAL","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.\n\nPhase 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.",[13],"Drug: intra-nasal ketorolac",{"label":15,"type":16,"description":17,"interventionNames":18},"Diclofenac","ACTIVE_COMPARATOR","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.",[19],"Drug: oral diclofenac",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","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.",[9],[9],{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"oral diclofenac","Control group to receive oral diclofenac, which is a comparable medication to intra-nasal ketorolac.",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Brett Johnson, MD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},"CONTACT","214\u002F645-8765","brett.johnson@utsouthwestern.edu",{"name":42,"role":38,"phone":39,"phoneExt":31,"email":43},"Isaac Palma-Zamora, MD","isaac.palma-zamora@utsouthwestern.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75390","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-96.80667,32.78306,{"lat":57,"lon":56},[60],{"name":34,"role":38,"phone":31,"phoneExt":31,"email":31},{"type":35,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Brett Johnson","Assistant Professor",[65],{"name":66,"class":67},"assertio Therapeutics, Inc","UNKNOWN","100528273","phase-1-intra-nasal-ketorolac-for-acute-ureteral-stent-associated-pain-following-ureteroscopy-for-stone-disease-100528273",false,"NCT06158620","Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease","Intra-nasal Ketorolac Versus Oral Diclofenac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease","Inclusion Criteria:\n\n* ≥18 years old\n* English-speaking\n* Candidate for unilateral ureteroscopy for treatment of urolithiasis\n* Surgical plan includes placement of a ureteral stent\n\nExclusion Criteria:\n\n* Pregnant\u002Fnursing, prisoners, cognitively impaired\n* Solitary kidney\n* Stone in transplant kidney\n* Anatomic abnormalities (i.e., ureteral stricture, infundibular stenosis, uretero-pelvic junction obstruction, horseshoe kidney, duplicated system)\n* History of ureteral reconstruction\n* History of nephrocalcinosis, medullary sponge kidney, cystinuria\n* Immobility or relative immobility\n* Planned staged ureteroscopy\n* History of ureteral stent complication or poor tolerance or a ureteral stent\n* Urinary tract infection or sepsis\n* Current anticoagulation use (81 mg Aspirin permissible)\n* NSAID contraindication (acute renal failure or chronic kidney disease, bleeding disorders, allergic reaction to NSAIDs, ulcer disease, auto-immune disease)","ALL","18 Years",{"count":78,"type":79},80,"ESTIMATED","INTERVENTIONAL",[82,83],"PHASE1","PHASE2","Objective: To improve quality-of-life and health care delivery to patients receiving ureteral stents.\n\nSpecific 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.\n\nHypotheses: 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.\n\nStudy 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.",[86,87,88,89],"Post Operative Pain","Urolithiasis","Ureter Calculi","Stent Complication","2026-05-22",{"date":92,"type":93},"2026-05-27","ACTUAL",{"date":95,"type":93},"2025-03-01",{"date":97,"type":79},"2027-12-01",{"name":5,"class":6},1]