Status:
COMPLETED
An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
American Regent, Inc.
Conditions:
Other Acute Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
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 18-65 who come to the ED seeking ca...
Detailed Description
Adults between the ages of 18-65 were being seen in the emergency department of a single large tertiary care hospital with acute pain (moderate to severe 4-10 NRS scale). Those who met inclusion crite...
Eligibility Criteria
Inclusion
- Patient is being seen in the emergency department (ED) in acute pain from an acute illness or injury (such as a kidney stone or an acute musculoskeletal injury)
- Age ≥ 18 years and \< 65 years
- Stable patient with stable vital signs, including not in shock (systolic BP \>90), not in respiratory failure, and not a multiple trauma patient
- Mentally competent patient is able to understand the consent form
- Baseline pain score is moderate to severe (e.g. on NRS ≥ 4 on a 0 to 10 NRS or ≥ 40 on a 0 to 100 NRS)
Exclusion
- Unstable patients
- Multiple trauma patients
- Patients with any allergies to ketorolac or any of the components in the nasal spray preparation
- Patients with active peptic ulcer disease
- Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDS
- Patients about to undergo major surgery
- Patients with renal disease or at risk for renal failure due to volume depletion
- Pregnant or nursing mothers
- Patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, and/or those at high-risk of bleeding
- Patient with a 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)
- Patient with any other contraindication to the use of Sprix, or in whom use of Sprix would not be consistent with the approved package insert
- History of chronic pain
- History of drug abuse
- History of significant neurologic disorder (could include diseases such as diabetic neuropathy, Parkinson's disease, etc)
- History of significant psychiatric disorder
- History of being on medications that may affect neurotransmitters (such as certain neurologic or psychiatric medications)
- No immediate post-op patients
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01471639
Start Date
November 1 2011
End Date
June 1 2012
Last Update
August 15 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195