This trial is active, not recruiting.

Condition other acute pain
Treatment intranasal ketorolac
Sponsor The Cleveland Clinic
Collaborator Luitpold Pharmaceuticals
Start date November 2011
End date June 2012
Trial size 30 participants
Trial identifier NCT01471639, LUI-S4


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
FDA approved drug used in single arm study
intranasal ketorolac Sprix
15 mg

Primary Outcomes

Pain scores on the visual analog scale
time frame: 20 (+/- 5 ) minutes after application of intranasal Ketorolac

Secondary Outcomes

Number of participants with adverse events
time frame: 20 minutes after application of intrnasal Ketorolac
Pain scores on the Visual Analog Scale
time frame: 40 (+/-) 5 ) minutes after application of intrnasal Ketorolac
Pain scores on the Visual Analog Scale
time frame: 1 hour (+/- 5 minutes) after application of intranasal Ketorolac
Pains scores on the visual analog scale
time frame: 2 hours (=/- 5 minutes) after application of intranasal Ketorolac
Satisfaction of patient and health care provider.
time frame: Within 1 hour of application of intrnasal Ketrolac

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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

Additional Information

Official title A Prospective, Open-label, Nonrandomized Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain
Principal investigator Sharon Mace, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.