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The Use of Intranasal Ketoralac for Pain Management

This study is currently recruiting participants.
Verified November 2012 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
David Hoenig, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01736358
First received: November 26, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Pain Management
Urolithiasis
 Drug: Intranasal Ketoralac
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluating Post-operative Pain Management Efficacy of Intra Nasal Ketorolac in Ambulatory Urological Surgeries-A Randomized Double-blinded Placebo Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Post-operative opioid requirements [ Time Frame: 3 hours after surgery ] [ Designated as safety issue: No ]
    To evaluate the role perioperative usage of single-dose of intranasal ketorolac on immediate post operative opioid requirements.


Secondary Outcome Measures:
  • Post operative pain score [ Time Frame: 3 hours after surgery ] [ Designated as safety issue: No ]
    To evaluate the post operative pain score 30 minutes after surgery, 1 hour after surgery, and 2 hours after surgery.


Other Outcome Measures:
  • Incidence of postoperative side effects [ Time Frame: 24 hours after procedure ] [ Designated as safety issue: Yes ]
    To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Drug: Intranasal Ketoralac
15.75 mg of Sprix in each nostril 20 minutes before end of surgery
Other Name: Sprix
Placebo Comparator: 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.
 Drug: Placebo
15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736358

Contacts
Contact: David Hoenig, MD 7189204073 dhoenig@montefiore.org
Contact: Singh Nair, MD 7189205932 sinair@montefiore.org

Locations
United States, New York
Montefiore Medical Center- Weiler Division Recruiting
Bronx, New York, United States, 10461
Contact: David Hoenig, MD     718-920-4073     dhoenig@montefiore.org    
Contact: Singh Nair, MD     7189205932     sinair@montefiore.org    
Principal Investigator: David Hoenig, MD            
Sub-Investigator: Singh Nair, MD            
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: David Hoenig, MD Montefiore Medical Center
Study Director: Singh Nair, MD Montefiore Medical Center
  More Information

Publications:

Responsible Party: David Hoenig, Associate Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01736358     History of Changes
Other Study ID Numbers: Sprix
Study First Received: November 26, 2012
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Sprix
Intranasal ketoralac
Ketoralac
Urolithiasis
Kidney stone
 Uretal stone
Ureteroscopic removal of stones
URS
Pain management
Pain

Additional relevant MeSH terms:
Pain, Postoperative
Urolithiasis
Postoperative Complications
Pathologic Processes
 Pain
Signs and Symptoms
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013