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

Primary Purpose

Other Acute Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

intranasal ketorolac

About this trial

This is an interventional treatment trial for Other Acute Pain focused on measuring 18 years and older,, previously healthy, men and nonpregnant women, emergency department

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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
History of being on medications that may affect neurotransmitters (such as certain neurologic or psychiatric medications)
No immediate post-op patients

Sites / Locations

Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intranasal ketorolac (Sprix)

Arm Description

FDA approved drug used in single arm study

Outcomes

Primary Outcome Measures

Efficacy of Intranasal Ketorolac on Numeric Pain Scale

Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain)

Secondary Outcome Measures

Adverse Event/Side Effects

Safety assessed by reporting of all adverse events and side effects.

Full Information

NCT ID

NCT01471639

First Posted

November 4, 2011

Last Updated

August 16, 2017

Sponsor

The Cleveland Clinic

Collaborators

American Regent, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01471639

Brief Title

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

Acronym

Sprix

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 Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

Collaborators

American Regent, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Other Acute Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intranasal ketorolac (Sprix)

Arm Type

Experimental

Arm Description

FDA approved drug used in single arm study

Intervention Type

Drug

Intervention Name(s)

intranasal ketorolac

Other Intervention Name(s)

Sprix

Intervention Description

15 mg

Primary Outcome Measure Information:

Title

Efficacy of Intranasal Ketorolac on Numeric Pain Scale

Description

Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain)

Time Frame

up to 4 hours

Secondary Outcome Measure Information:

Title

Adverse Event/Side Effects

Description

Safety assessed by reporting of all adverse events and side effects.

Time Frame

Up to 4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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 History of being on medications that may affect neurotransmitters (such as certain neurologic or psychiatric medications) No immediate post-op patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon Mace, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

22711895

Citation

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.

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

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