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

NCT01471639 | Completed Results

• 1 other identifier: LUI-S4
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Acute Pain

Keywords

18 years and older,; previously healthy; men and nonpregnant women; emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Event/Side Effects

  Up to 4 hours

Study Arms (1)

Intranasal ketorolac (Sprix)

EXPERIMENTAL

FDA approved drug used in single arm study

Drug: intranasal ketorolac

Interventions

intranasal ketorolac DRUG

15 mg

Also known as: Sprix

Intranasal ketorolac (Sprix)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Age ≥ 18 years and \< 65 years
• Stable patient with stable vital signs, including not in shock (systolic BP \>90), not in respiratory failure, and not a multiple trauma patient
• Mentally competent patient is able to understand the consent form
• 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)

You may not qualify if:

• Unstable patients
• Multiple trauma patients
• Patients with any allergies to ketorolac or any of the components in the nasal spray preparation
• Patients with active peptic ulcer disease
• Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDS
• Patients about to undergo major surgery
• Patients with renal disease or at risk for renal failure due to volume depletion
• Pregnant or nursing mothers
• Patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, and/or those at high-risk of bleeding
• 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)
• 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
• History of chronic pain
• History of drug abuse
• History of significant neurologic disorder (could include diseases such as diabetic neuropathy, Parkinson's disease, etc)
• History of significant psychiatric disorder

Sponsors & Collaborators

• The Cleveland Clinic: lead
• American Regent, Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 22711895 BACKGROUND

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1; Emergencies

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Sharon Mace MD
• Organization: Cleveland Clinic Healthcare System

maces@ccf.org

216-445-4598

Study Officials

• Sharon Mace, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 15, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 15, 2025
• Results First Posted: September 12, 2017

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)