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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Luitpold Pharmaceuticals
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01471639
First received: November 4, 2011
Last updated: February 13, 2013
Last verified: February 2013

November 4, 2011
February 13, 2013
November 2011
April 2013   (final data collection date for primary outcome measure)
Pain scores on the visual analog scale [ Time Frame: 20 (+/- 5 ) minutes after application of intranasal Ketorolac ] [ Designated as safety issue: No ]
Numeric rating scale (VAS) 0-10 ,0 (no pain)- 5 (moderate pain)- (10) worst pain . Scale to be utilized after application of intranasal Ketorolac.
Change from Baseline Vital Signs and Pain Scales After Drug Administration in Patients with Acute Pain Reporting to the ED [ Time Frame: 20 minutes after administration, then 2-6 hours after (if applicable) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01471639 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events [ Time Frame: 20 minutes after application of intrnasal Ketorolac ] [ Designated as safety issue: Yes ]
    Utilized as a measure of safety and tolerability.
  • Pain scores on the Visual Analog Scale [ Time Frame: 40 (+/-) 5 ) minutes after application of intrnasal Ketorolac ] [ Designated as safety issue: No ]
    Numeric rating scale (VAS) 0-10 ,0 (no pain)- 5 (moderate pain)- (10) worst pain . Scale to be utilized after application of intranasal Ketorolac.
  • Pain scores on the Visual Analog Scale [ Time Frame: 1 hour (+/- 5 minutes) after application of intranasal Ketorolac ] [ Designated as safety issue: No ]
    Numeric rating scale (VAS) 0-10 ,0 (no pain)- 5 (moderate pain)- (10) worst pain . Scale to be utilized after application of intranasal Ketorolac.
  • Pains scores on the visual analog scale [ Time Frame: 2 hours (=/- 5 minutes) after application of intranasal Ketorolac ] [ Designated as safety issue: No ]
    Numeric rating scale (VAS) 0-10 ,0 (no pain)- 5 (moderate pain)- (10) worst pain . Scale to be utilized after application of intranasal Ketorolac.
  • Satisfaction of patient and health care provider. [ Time Frame: Within 1 hour of application of intrnasal Ketrolac ] [ Designated as safety issue: No ]
    Questionnaire for both the patient and the healthcare provider to be completed after the intravenous cannulation.
Changes in vital signs, nasal mucosa, and/or adverse events/side effects after drug administration in an acute care setting, the ED. [ Time Frame: 20 minutes after administration, then 2-6 hours after (if applicable) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Other Acute Pain
Drug: intranasal ketorolac
15 mg
Other Name: Sprix
Experimental: Intranasal ketorolac (Sprix)
FDA approved drug used in single arm study
Intervention: Drug: intranasal ketorolac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01471639
LUI-S4
No
The Cleveland Clinic
The Cleveland Clinic
Luitpold Pharmaceuticals
Principal Investigator: Sharon Mace, MD The Cleveland Clinic
The Cleveland Clinic
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP