The Use of Intranasal Ketoralac for Pain Management
Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain Management; Urolithiasis
Intervention: Intranasal Ketoralac (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Montefiore Medical Center Official(s) and/or principal investigator(s): David Hoenig, MD, Principal Investigator, Affiliation: Montefiore Medical Center Singh Nair, MD, Study Director, Affiliation: Montefiore Medical Center
Overall contact: David Hoenig, MD, Phone: 7189204073, Email: dhoenig@montefiore.org
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.
Clinical Details
Official title: Evaluating Post-operative Pain Management Efficacy of Intra Nasal Ketorolac in Ambulatory Urological Surgeries-A Randomized Double-blinded Placebo Controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Post-operative opioid requirements
Secondary outcome: Post operative pain score
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Ureteroscopic stone removal surgeries with stenting
- Age ≥ 18 years and < 65 years
- Stable patient with stable vital signs
- Mentally competent and is able to understand consent form
Exclusion Criteria:
- Unstable patients
- Patients with multiple trauma sites
- Patients with allergies to ketorolac or any of the components in the nasal spray
preparation
- Patients with active peptic ulcer disease
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin
or other NSAIDs
- Renal disease or at risk for renal failure due to volume depletion
- Pregnant or nursing mothers
- Nasal abnormality or illness that could affect the absorption of intranasal
medication (such as: nasal discharge, rhinitis, acute upper respiratory infection,
acute epistaxis, nasal polyp, nasal tumor)
- Any other contraindication to the use of Sprix, or in whom use of Sprix would not be
consistent with the approved package insert
Locations and Contacts
David Hoenig, MD, Phone: 7189204073, Email: dhoenig@montefiore.org
Montefiore Medical Center- Weiler Division, Bronx, New York 10461, United States; Recruiting David Hoenig, MD, Phone: 718-920-4073, Email: dhoenig@montefiore.org Singh Nair, MD, Phone: 7189205932, Email: sinair@montefiore.org David Hoenig, MD, Principal Investigator Singh Nair, MD, Sub-Investigator
Additional Information
Related publications: 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. Pak CY, Resnick MI, Preminger GM. Ethnic and geographic diversity of stone disease. Urology. 1997 Oct;50(4):504-7. 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. Tiselius HG. Epidemiology and medical management of stone disease. BJU Int. 2003 May;91(8):758-67. Review. Erhard M, Salwen J, Bagley DH. Ureteroscopic removal of mid and proximal ureteral calculi. J Urol. 1996 Jan;155(1):38-42. Erratum in: J Urol 1996 Mar;155(3):1039. 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. Bromwich EJ, Lockyer R, Keoghane SR. Day-case rigid and flexible ureteroscopy. Ann R Coll Surg Engl. 2007 Jul;89(5):526-8. 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. 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. Erratum in: Anesth Analg. 2009 Mar;108(3):991. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text. 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. 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. Erratum in: Pain Med. 2011 Jun;12(6):990. Dosage error in published abstract; MEDLINE/PubMed abstract corrected. 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. Erratum in: Curr Med Res Opin. 2012 Jun;28(6):1052. 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.
Starting date: October 2012
Last updated: November 28, 2012
|