Clinical Trial: An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Open-label, Nonrandomized Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain

Brief Summary:

The purpose of this study is to determine the effectiveness, the safety, and the tolerability of intranasal ketorolac (Sprix) in relieving acute pain in adults ages 18-64 who come to the ED seeking care. Considering all ED visits, pain is the most common chief complaint. Giving intranasal ketorolac (Sprix) after stomach and dental surgeries has been shown to be safe and effective, but no studies have investigated the use of intranasal ketorolac (Sprix) for the treatment of acute pain in the ED.

Ketorolac (Sprix) has several advantages over other drugs commonly given for pain, including opioids. Ketorolac (Sprix) is non-addicting and has fewer side effects than opioids. The administration of ketorolac (Sprix) by other methods, such as IV, intramuscular shot, and oral pill form, has been shown to be safe and effective in treating acute pain.

This study is being done to find out if giving ketorolac (Sprix) as a single dose nasal spray will have the same benefit in decreasing patient's pain.


Detailed Summary:
Sponsor: The Cleveland Clinic

Current Primary Outcome: Pain scores on the visual analog scale [ Time Frame: 20 (+/- 5 ) minutes after application of intranasal Ketorolac ]

Numeric rating scale (VAS) 0-10 ,0 (no pain)- 5 (moderate pain)- (10) worst pain . Scale to be utilized after application of intranasal Ketorolac.


Original Primary Outcome: Change from Baseline Vital Signs and Pain Scales After Drug Administration in Patients with Acute Pain Reporting to the ED [ Time Frame: 20 minutes after administration, then 2-6 hours after (if applicable) ]

Current Secondary Outcome:

  • Number of participants with adverse events [ Time Frame: 20 minutes after application of intrnasal Ketorolac ]
    Utilized as a measure of safety and tolerability.
  • Pain scores on the Visual Analog Scale [ Time Frame: 40 (+/-) 5 ) minutes after application of intrnasal Ketorolac ]
    Numeric rating scale (VAS) 0-10 ,0 (no pain)- 5 (moderate pain)- (10) worst pain . Scale to be utilized after application of intranasal Ketorolac.
  • Pain scores on the Visual Analog Scale [ Time Frame: 1 hour (+/- 5 minutes) after application of intranasal Ketorolac ]
    Numeric rating scale (VAS) 0-10 ,0 (no pain)- 5 (moderate pain)- (10) worst pain . Scale to be utilized after application of intranasal Ketorolac.
  • Pains scores on the visual analog scale [ Time Frame: 2 hours (=/- 5 minutes) after application of intranasal Ketorolac ]
    Numeric rating scale (VAS) 0-10 ,0 (no pain)- 5 (moderate pain)- (10) worst pain . Scale to be utilized after application of intranasal Ketorolac.
  • Satisfaction of patient and health care provider. [ Time Frame: Within 1 hour of application of intrnasal Ketrolac ]
    Questionnaire for both the patient and the healthcare provider to be completed after the intravenous cannulation.


Original Secondary Outcome: Changes in vital signs, nasal mucosa, and/or adverse events/side effects after drug administration in an acute care setting, the ED. [ Time Frame: 20 minutes after administration, then 2-6 hours after (if applicable) ]

Information By: The Cleveland Clinic

Dates:
Date Received: November 4, 2011
Date Started: November 2011
Date Completion:
Last Updated: January 16, 2017
Last Verified: January 2017