An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain (Sprix)
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 18-65 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective, Open-label, Nonrandomized Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain|
- Efficacy of Intranasal Ketorolac on Numeric Pain Scale [ Time Frame: up to 4 hours ]Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain)
- Adverse Event/Side Effects [ Time Frame: Up to 4 hours ]Safety assessed by reporting of all adverse events and side effects.
|Study Start Date:||November 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Intranasal ketorolac (Sprix)
FDA approved drug used in single arm study
Drug: intranasal ketorolac
Other Name: Sprix
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471639
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Sharon Mace, MD||The Cleveland Clinic|