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

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.

Timeline

Start

2025-03-01

Primary completion

2027-04-01

Completion

2027-12-01

Publications

• Background Pearle MS. Medical therapy for urinary stone passage. Lancet. 2006 Sep 30;368(9542):1138-9. doi: 10.1016/S0140-6736(06)69452-X. No abstract available.
• Background Bensalah K, Tuncel A, Gupta A, Raman JD, Pearle MS, Lotan Y. Determinants of quality of life for patients with kidney stones. J Urol. 2008 Jun;179(6):2238-43; discussion 2243. doi: 10.1016/j.juro.2008.01.116. Epub 2008 Apr 18.
• Background Saigal CS, Joyce G, Timilsina AR; Urologic Diseases in America Project. Direct and indirect costs of nephrolithiasis in an employed population: opportunity for disease management? Kidney Int. 2005 Oct;68(4):1808-14. doi: 10.1111/j.1523-1755.2005.00599.x.
• Background Shoag J, Halpern J, Goldfarb DS, Eisner BH. Risk of chronic and end stage kidney disease in patients with nephrolithiasis. J Urol. 2014 Nov;192(5):1440-5. doi: 10.1016/j.juro.2014.05.117. Epub 2014 Jun 11.
• Background Alexander RT, Hemmelgarn BR, Wiebe N, Bello A, Morgan C, Samuel S, Klarenbach SW, Curhan GC, Tonelli M; Alberta Kidney Disease Network. Kidney stones and kidney function loss: a cohort study. BMJ. 2012 Aug 29;345:e5287. doi: 10.1136/bmj.e5287.
• Background Ljunghall S, Danielson BG. A prospective study of renal stone recurrences. Br J Urol. 1984 Apr;56(2):122-4. doi: 10.1111/j.1464-410x.1984.tb05346.x.
• Background Uribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006.
• Background Vadivelu N, Gowda AM, Urman RD, Jolly S, Kodumudi V, Maria M, Taylor R Jr, Pergolizzi JV Jr. Ketorolac tromethamine - routes and clinical implications. Pain Pract. 2015 Feb;15(2):175-93. doi: 10.1111/papr.12198. Epub 2014 Apr 16.
• Background Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564.
• Background Johnson BA, Sorokin I, Antonelli J, Pearle M. Efficacy of Intramuscular Ketorolac for Preventing Renal Colic Post Stent Removal: Randomized Controlled Trial. J Urol. 2022 Sep;208(3):650-657. doi: 10.1097/JU.0000000000002750. Epub 2022 Jun 2.
• Background Harper JD, Desai AC, Antonelli JA, Tasian GE, Ziemba JB, Al-Khalidi HR, Lai HH, Maalouf NM, Reese PP, Wessells HB, Kirkali Z, Scales CD Jr; NIDDK Urinary Stone Disease Research Network (USDRN). Quality of life impact and recovery after ureteroscopy and stent insertion: insights from daily surveys in STENTS. BMC Urol. 2022 Apr 6;22(1):53. doi: 10.1186/s12894-022-01004-9.
• Background Allam CL, Aden JK, Reed AM. The Role of Routine Ureteral Stenting Following Uncomplicated Ureteroscopic Treatment for Upper Ureteral and Renal Stones: A Randomized Control Trial. J Endourol. 2023 Mar;37(3):257-263. doi: 10.1089/end.2022.0386. Epub 2023 Jan 9.

Drugs

Indications