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

Other Acute Pain Clinical Trial

— Sprix  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471639
• Other study ID #: LUI-S4
• Status: Completed
• Phase: N/A
• First received: November 4, 2011
• Last updated: January 16, 2017
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies
• Other Acute Pain

Intervention

Drug:
• intranasal ketorolac
15 mg

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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