Study Summary
This trial is studying whether the drug Ketorolac can help reduce symptoms related to stents.
Eligible Conditions
- Ureteral Stent Placement
- Kidney Stones
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: 1 to 2 months post stent removal
Month 2
Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit
Stent insertion Day 1
Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1
Day 14
Analog Pain Scale, 0 - 10 rating of pain - Stent removal
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Intervention Group - Ketorlac (NSAID)
1 of 2
Placebo Group - Normal Saline
1 of 2
Active Control
Non-Treatment Group
36 Total Participants · 2 Treatment Groups
Primary Treatment: Intervention Group - Ketorlac (NSAID) · Has Placebo Group · Phase < 1
Intervention Group - Ketorlac (NSAID)
Drug
ActiveComparator Group · 1 Intervention: Ketorolac Trometamol 30Mg/1mL Injection · Intervention Types: DrugPlacebo Group - Normal Saline
Drug
PlaceboComparator Group · 1 Intervention: Normal saline · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 to 2 months post stent removal
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,803 Previous Clinical Trials
2,279,413 Total Patients Enrolled
Alana Desai, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
5 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are 18 years of age or older and willing and able to provide informed consent.
References
- De Oliveira, Gildasio S., Deepti Agarwal, and Honorio T. Benzon. 2012. “Perioperative Single Dose Ketorolac to Prevent Postoperative Pain”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e3182334d68.
- JOSHI, H.B., A. STAINTHORPE, R.P. MacDONAGH, F.X. KEELEY, and A.G. TIMONEY. 2003. “Indwelling Ureteral Stents: Evaluation of Symptoms, Quality of Life and Utility”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.ju.0000048980.33855.90.
- Beiko, Darren T., James D. Watterson, Bodo E. Knudsen, Linda Nott, Stephen E. Pautler, Gerald B. Brock, Hassan Razvi, and John D. Denstedt. 2004. “Second Prize: Double-blind Randomized Controlled Trial Assessing the Safety and Efficacy of Intravesical Agents for Ureteral Stent Symptoms After Extracorporeal Shockwave Lithotripsy”. Journal of Endourology. Mary Ann Liebert Inc. doi:10.1089/end.2004.18.723.
- Assimos, Dean, Amy Krambeck, Nicole L. Miller, Manoj Monga, M. Hassan Murad, Caleb P. Nelson, Kenneth T. Pace, et al.. 2016. “Surgical Management of Stones: American Urological Association/endourological Society Guideline, PART II”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2016.05.091.
- Elwood, Chelsea N., Dirk Lange, Richard Nadeau, Shannon Seney, Kelly Summers, Ben H. Chew, John D. Denstedt, and Peter A. Cadieux. 2010. “Novelin Vitromodel for Studying Ureteric Stent-induced Cell Injury”. BJU International. Wiley. doi:10.1111/j.1464-410x.2009.09001.x.
- Lamb, Alastair D., Sarah L. Vowler, Richard Johnston, Nick Dunn, and Oliver J. Wiseman. 2011. “Meta-analysis Showing the Beneficial Effect of Α-blockers on Ureteric Stent Discomfort”. BJU International. Wiley. doi:10.1111/j.1464-410x.2011.10170.x.
- Norris, Regina D., Roger L. Sur, W. Patrick Springhart, Charles G. Marguet, Barbara J. Mathias, Paul K. Pietrow, David M. Albala, and Glenn M. Preminger. 2008. “A Prospective, Randomized, Double-blinded Placebo-controlled Comparison of Extended Release Oxybutynin Versus Phenazopyridine for the Management of Postoperative Ureteral Stent Discomfort”. Urology. Elsevier BV. doi:10.1016/j.urology.2007.11.004.
- Krambeck, Amy E., Robert S. Walsh, John D. Denstedt, Glenn M. Preminger, Jamie Li, John C. Evans, James E. Lingeman, and Lexington Trial Study Group. 2010. “A Novel Drug Eluting Ureteral Stent: A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of a Ketorolac Loaded Ureteral Stent”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2009.11.035.
- Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31.
- De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.
- Joshi HB, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003 Mar;169(3):1065-9; discussion 1069. doi: 10.1097/01.ju.0000048980.33855.90.
- Beiko DT, Watterson JD, Knudsen BE, Nott L, Pautler SE, Brock GB, Razvi H, Denstedt JD. Double-blind randomized controlled trial assessing the safety and efficacy of intravesical agents for ureteral stent symptoms after extracorporeal shockwave lithotripsy. J Endourol. 2004 Oct;18(8):723-30. doi: 10.1089/end.2004.18.723.
- 2018. "NSAIDs Stent Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03638999.
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Cancer Related
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