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Interim analysis showed futility of primary endpoint
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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.
The prevalence and incidence of urolithiasis, or kidney stone disease, are increasing in the general population. Life-time incidence of urolithiasis is estimated to be between 5%- 12%. The treatment of kidney stones depends on stone type and size, symptom severity, and the presence of obstruction.
URS is a common ambulatory procedure as improved technological advances and increased clinical utilization have helped decrease postoperative complications. Despite an overall reduction in the perioperative complication rate, post operative pain management after URS remains a major factor delaying discharge of patients.
Post operative pain after URS is usually treated with opioids and non steroidal anti inflammatory drugs. Intranasal ketorolac (SprixTM) is an FDA approved pain formulation for short term management (5 days) of moderate to moderately severe pain that requires analgesia at the opioid level. The efficacy of intranasal ketorolac formulation was demonstrated in placebo-controlled studies in patients following major surgeries.
The primary objective of the study is to evaluate the role perioperative usage of single-dose of intranasal ketorolac on immediate post operative opioid requirements. Secondary objectives of the study are to (a) evaluate the post operative pain score 30 minutes after surgery, 1 hour after surgery, and 2 hours after surgery, (b) find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population, (c) find the level of anesthesia satisfaction in the target population, (d) find the time to discharge in the target population, (e) compare the two groups post anesthesia discharge score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Ketoralac | Experimental | A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. |
|
| Placebo | Placebo Comparator | A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Ketoralac | Drug | 15.75 mg of Sprix in each nostril 20 minutes before end of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Opioid Requirements | this study will assess the effect of perioperative usage of single-dose of intranasal ketorolac on post operative opioid requirements within 3 hours after surgery. | 3 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Pain Score | To evaluate the post operative pain score using the Visual Analog Scale (VAS) 30 minutes after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain. | 30 minutes after surgery |
| Post Operative Pain Score |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Side Effects | To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population. | 24 hours after procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Singh Nair, MD | Montefiore Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center- Weiler Division | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16164658 | 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. | |
| 9338722 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Ketoralac | A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery |
| FG001 | Placebo | A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Ketoralac | A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Opioid Requirements | this study will assess the effect of perioperative usage of single-dose of intranasal ketorolac on post operative opioid requirements within 3 hours after surgery. | Posted | Median | Inter-Quartile Range | mg | 3 hours after surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intranasal Ketoralac | A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.David Hoenig | Montefiore Medical Center | dhoenig@montefiore.org |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D007669 | Kidney Calculi |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery |
|
To evaluate the post operative pain score using the Visual Analog Scale (VAS) 1 hour after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.
| 1 hour after surgery |
| Post Operative Pain Scale | To evaluate the post operative pain score using the Visual Analog Scale (VAS) 2 hours after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain. | 2 hours after surgery |
| 10569535 | 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. |
| 12709088 | 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. |
| 7490892 | Background | Erhard M, Salwen J, Bagley DH. Ureteroscopic removal of mid and proximal ureteral calculi. J Urol. 1996 Jan;155(1):38-42. |
| 11744457 | 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. |
| 17688729 | 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. |
| 22323972 | 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. |
| 19020154 | 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. |
| 17192497 | 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. |
| 19594851 | 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. |
| 20557145 | 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. |
| 20207062 | 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. |
A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Post Operative Pain Score | To evaluate the post operative pain score using the Visual Analog Scale (VAS) 30 minutes after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain. | Posted | Median | Inter-Quartile Range | score on a scale | 30 minutes after surgery |
|
|
|
| Secondary | Post Operative Pain Score | To evaluate the post operative pain score using the Visual Analog Scale (VAS) 1 hour after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain. | Posted | Median | Inter-Quartile Range | score on a scale | 1 hour after surgery |
|
|
|
| Secondary | Post Operative Pain Scale | To evaluate the post operative pain score using the Visual Analog Scale (VAS) 2 hours after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain. | Posted | Median | Inter-Quartile Range | score on a scale | 2 hours after surgery |
|
|
|
| Other Pre-specified | Incidence of Postoperative Side Effects | To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population. | Posted | Number | number of events | 24 hours after procedure |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery | 0 | 23 | 0 | 23 | 0 | 23 |
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| D052801 | Male Urogenital Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |