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
Luitpold Pharmaceuticals
Information provided by (Responsible Party):
The Cleveland Clinic

November 4, 2011
November 15, 2011
April 17, 2017
September 12, 2017
September 12, 2017
November 2011
June 2012   (Final data collection date for primary outcome measure)
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)
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) ]
Complete list of historical versions of study NCT01471639 on Archive Site
Adverse Event/Side Effects [ Time Frame: Up to 4 hours ]
Safety assessed by reporting of all adverse events and side effects.
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) ]
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 18-65 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.

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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (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
Pfaffenrath V, Fenzl E, Bregman D, Färkkila M. Intranasal ketorolac tromethamine (SPRIX(R)) containing 6% of lidocaine (ROX-828) for acute treatment of migraine: safety and efficacy data from a phase II clinical trial. Cephalalgia. 2012 Jul;32(10):766-77. doi: 10.1177/0333102412451359. Epub 2012 Jun 18.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2012
June 2012   (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: Undecided
The Cleveland Clinic
The Cleveland Clinic
Luitpold Pharmaceuticals
Principal Investigator: Sharon Mace, MD The Cleveland Clinic
The Cleveland Clinic
August 2017

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