drugset / Trial / NCT01736358
The Use of Intranasal Ketoralac for Pain Management (Sprix)
RandomizedParallel-groupDouble-blindSupportive care
Summary
Despite an overall reduction in the perioperative complication rate, post operative pain management after ureteroscopic removal of stones (URS) remains a major factor delaying discharge of patients. The investigators hypothesize that perioperative usage of intranasal ketorolac will provide a reduction in post operative opioid requirements, better post operative pain control, higher anesthesia satisfaction and faster recovery.
Timeline
- Start
- 2012-10
- Primary completion
- 2014-06
- Completion
- 2014-06
Publications
- 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 Pak CY, Resnick MI, Preminger GM. Ethnic and geographic diversity of stone disease. Urology. 1997 Oct;50(4):504-7. doi: 10.1016/s0090-4295(97)00307-5.
- Background Peschel R, Janetschek G, Bartsch G. Extracorporeal shock wave lithotripsy versus ureteroscopy for distal ureteral calculi: a prospective randomized study. J Urol. 1999 Dec;162(6):1909-12. doi: 10.1016/S0022-5347(05)68066-4.
- Background Tiselius HG. Epidemiology and medical management of stone disease. BJU Int. 2003 May;91(8):758-67. doi: 10.1046/j.1464-410x.2003.04208.x.
- Background Erhard M, Salwen J, Bagley DH. Ureteroscopic removal of mid and proximal ureteral calculi. J Urol. 1996 Jan;155(1):38-42.
- Background Cheung MC, Lee F, Leung YL, Wong BB, Chu SM, Tam PC. Outpatient ureteroscopy: predictive factors for postoperative events. Urology. 2001 Dec;58(6):914-8. doi: 10.1016/s0090-4295(01)01445-5.
- Background Bromwich EJ, Lockyer R, Keoghane SR. Day-case rigid and flexible ureteroscopy. Ann R Coll Surg Engl. 2007 Jul;89(5):526-8. doi: 10.1308/003588407X187676.
- Background Ahn ST, Kim JH, Park JY, Moon du G, Bae JH. Acute postoperative pain after ureteroscopic removal of stone: incidence and risk factors. Korean J Urol. 2012 Jan;53(1):34-9. doi: 10.4111/kju.2012.53.1.34. Epub 2012 Jan 25.
- Background Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736.
- Background McAleer SD, Majid O, Venables E, Polack T, Sheikh MS. Pharmacokinetics and safety of ketorolac following single intranasal and intramuscular administration in healthy volunteers. J Clin Pharmacol. 2007 Jan;47(1):13-8. doi: 10.1177/0091270006294597.
- Background Brown C, Moodie J, Bisley E, Bynum L. Intranasal ketorolac for postoperative pain: a phase 3, double-blind, randomized study. Pain Med. 2009 Sep;10(6):1106-14. doi: 10.1111/j.1526-4637.2009.00647.x. Epub 2009 Jul 6.
- 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 Grant GM, Mehlisch DR. Intranasal ketorolac for pain secondary to third molar impaction surgery: a randomized, double-blind, placebo-controlled trial. J Oral Maxillofac Surg. 2010 May;68(5):1025-31. doi: 10.1016/j.joms.2009.10.023. Epub 2010 Mar 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketorolac | Other / unclassified | 31.5 mg | Intranasal |