The Use of Intranasal Ketoralac for Pain Management (Sprix)

NCT01736358 | Terminated Phase 4 Results DMC

• 1 other identifier: 12-02-244
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain Management; Urolithiasis

Keywords

Sprix; Intranasal ketoralac; Ketoralac; Urolithiasis; Kidney stone; Uretal stone; Ureteroscopic removal of stones; URS; Pain management; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Post Operative Pain Score

  30 minutes after surgery

• Post Operative Pain Score

  1 hour after surgery

• Post Operative Pain Scale

  2 hours after surgery

Other Outcomes (1)

• Incidence of Postoperative Side Effects

  24 hours after procedure

Study Arms (2)

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.

Drug: Intranasal Ketoralac

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.

Drug: Placebo

Interventions

Intranasal Ketoralac DRUG

15.75 mg of Sprix in each nostril 20 minutes before end of surgery

Also known as: Sprix

Intranasal Ketoralac

Placebo DRUG

15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center- Weiler Division

The Bronx, New York, 10461, United States

Location

Related Publications (13)

• 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.

  PMID: 16164658 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.

  PMID: 9338722 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.

  PMID: 10569535 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.

  PMID: 12709088 BACKGROUND

• Erhard M, Salwen J, Bagley DH. Ureteroscopic removal of mid and proximal ureteral calculi. J Urol. 1996 Jan;155(1):38-42.

  PMID: 7490892 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.

  PMID: 11744457 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.

  PMID: 17688729 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.

  PMID: 22323972 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.

  PMID: 19020154 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.

  PMID: 17192497 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.

  PMID: 19594851 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.

  PMID: 20557145 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.

  PMID: 20207062 BACKGROUND

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi; Agnosia; Pain

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr.David Hoenig
• Organization: Montefiore Medical Center

dhoenig@montefiore.org

Study Officials

• Singh Nair, MD

  Montefiore Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dept of Urology

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 13, 2020
• Results First Posted: February 13, 2020

Record last verified: 2020-02

Locations

US (1)