The Use of Intranasal Ketoralac for Pain Management

This study is currently recruiting participants. (see Contacts and Locations)
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

November 26, 2012
November 28, 2012
October 2012
October 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01736358 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
The Use of Intranasal Ketoralac for Pain Management
Evaluating Post-operative Pain Management Efficacy of Intra Nasal Ketorolac in Ambulatory Urological Surgeries-A Randomized Double-blinded Placebo Controlled Study

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Postoperative Pain Management
  • Urolithiasis
  • Drug: Intranasal Ketoralac
    15.75 mg of Sprix in each nostril 20 minutes before end of surgery
    Other Name: Sprix
  • Drug: Placebo
    15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
  • 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.
    Intervention: Drug: Intranasal Ketoralac
  • 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.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: David Hoenig, MD 7189204073 dhoenig@montefiore.org
Contact: Singh Nair, MD 7189205932 sinair@montefiore.org
United States
 
NCT01736358
Sprix
Yes
David Hoenig, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Principal Investigator: David Hoenig, MD Montefiore Medical Center
Study Director: Singh Nair, MD Montefiore Medical Center
Montefiore Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP