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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01471639
Recruitment Status : Completed
First Posted : November 15, 2011
Results First Posted : September 12, 2017
Last Update Posted : September 12, 2017
American Regent, Inc.
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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 18-65 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 or disease Intervention/treatment Phase
Other Acute Pain Drug: intranasal ketorolac Not Applicable

Detailed Description:
Adults between the ages of 18-65 were being seen in the emergency department of a single large tertiary care hospital with acute pain (moderate to severe 4-10 NRS scale). Those who met inclusion criteria were approached. Informed written consent was obtained from all participants. The study was approved by local Institutional Review Board (IRB). Demographics (age, gender, ethnicity) were recorded. Baseline pain scores on NRS were obtained prior to administration of the drug. Pain scores (NRS) after administration of the drug (intranasal ketorolac) were recorded. All adverse events/side effects were recorded. Data was obtained for the time the individual patient was in the emergency department being treated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intranasal ketorolac (Sprix)
FDA approved drug used in single arm study
Drug: intranasal ketorolac
15 mg
Other Name: Sprix

Primary Outcome Measures :
  1. Efficacy of Intranasal Ketorolac on Numeric Pain Scale [ Time Frame: up to 4 hours ]
    Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain)

Secondary Outcome Measures :
  1. Adverse Event/Side Effects [ Time Frame: Up to 4 hours ]
    Safety assessed by reporting of all adverse events and side effects.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01471639

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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
American Regent, Inc.
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Principal Investigator: Sharon Mace, MD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by The Cleveland Clinic:
Informed Consent Form  [PDF] September 21, 2011

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Responsible Party: The Cleveland Clinic Identifier: NCT01471639     History of Changes
Other Study ID Numbers: LUI-S4
First Posted: November 15, 2011    Key Record Dates
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by The Cleveland Clinic:
18 years and older,
previously healthy
men and nonpregnant women
emergency department
Additional relevant MeSH terms:
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Ketorolac Tromethamine
Acute Pain
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action