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

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.

Study Overview

• Status: Completed
• Conditions: Other Acute Pain
• Intervention / Treatment: Drug: intranasal ketorolac

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intranasal ketorolac (Sprix); FDA approved drug used in single arm study	Drug: intranasal ketorolac; 15 mg; Other Names: Sprix

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event/Side Effects	Safety assessed by reporting of all adverse events and side effects.	Up to 4 hours

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: American Regent, Inc.
• Investigators: Principal Investigator: Sharon Mace, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• Pfaffenrath V, Fenzl E, Bregman D, Farkkila 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 4, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimated): November 15, 2011

Study Record Updates

• Last Update Posted (Actual): August 15, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: emergency department; 18 years and older,; previously healthy; men and nonpregnant women
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Disease Attributes; Emergencies; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: LUI-S4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No