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



Status:Active, not recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 64
Updated:7/2/2016
Start Date:November 2011
End Date:June 2016

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

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.


Inclusion Criteria:

1. 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)

2. Age ≥ 18 years and < 65 years

3. Stable patient with stable vital signs, including not in shock (systolic BP >90), not
in respiratory failure, and not a multiple trauma patient

4. Mentally competent patient is able to understand the consent form

5. 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 Criteria:

1. Unstable patients

2. Multiple trauma patients

3. Patients with any allergies to ketorolac or any of the components in the nasal spray
preparation

4. Patients with active peptic ulcer disease

5. Patients with a history of asthma, urticaria, or other allergic-type reactions after
taking aspirin or other NSAIDS

6. Patients about to undergo major surgery

7. Patients with renal disease or at risk for renal failure due to volume depletion

8. Pregnant or nursing mothers

9. Patients with suspected or confirmed cerebrovascular bleeding, patients with
hemorrhagic diathesis, and/or those at high-risk of bleeding

10. 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)

11. 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

12. History of chronic pain

13. History of drug abuse

14. History of significant neurologic disorder (could include diseases such as diabetic
neuropathy, Parkinson's disease, etc)

15. History of significant psychiatric disorder

16. History of being on medications that may affect neurotransmitters (such as certain
neurologic or psychiatric medications)

17. No immediate post-op patients
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
2024
mi
from 98109
Cleveland, OH
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