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
  Purpose

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.


Condition Intervention
Other Acute Pain
Drug: intranasal ketorolac

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Nonrandomized Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal ketorolac (Sprix)
FDA approved drug used in single arm study
Drug: intranasal ketorolac
15 mg
Other Name: Sprix

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471639

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Luitpold Pharmaceuticals
Investigators
Principal Investigator: Sharon Mace, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01471639     History of Changes
Other Study ID Numbers: LUI-S4
Study First Received: November 4, 2011
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
18-64 yr old,
previously healthy
men and nonpregnant women
emergency department

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014