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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.
ClinicalTrials.gov Identifier: NCT01471639
Recruitment Status : Completed
First Posted : November 15, 2011
Results First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
American Regent, Inc.
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Other Acute Pain
Intervention Drug: intranasal ketorolac
Enrollment 37
Recruitment Details December 01, 2011 Emergency Department
Pre-assignment Details Chronic pain, critical illness
Arm/Group Title Intranasal Ketorolac (Sprix)
Hide Arm/Group Description

FDA approved drug used in single arm study

intranasal ketorolac: 15 mg

Period Title: Overall Study
Started 37
Completed 37
Not Completed 0
Arm/Group Title Intranasal Ketorolac (Sprix)
Hide Arm/Group Description

FDA approved drug used in single arm study

intranasal ketorolac: 15 mg

Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
<=18 years
0
   0.0%
Between 18 and 65 years
37
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
37.2  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
23
  62.2%
Male
14
  37.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Hispanic or Latino
1
   2.7%
Not Hispanic or Latino
34
  91.9%
Unknown or Not Reported
2
   5.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
24
  64.9%
White
13
  35.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants
37
1.Primary Outcome
Title Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Hide Description Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain)
Time Frame up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Improvement in pain score rating among participants rating from baseline pain scores, 20 minutes, 40 minutes, 1 hour, 2 hour, 3 hour and 4 hour post dose. Pain scale ranging from 0 (no pain) - 10 (worst possible pain)
Arm/Group Title Intranasal Ketorolac (Sprix)
Hide Arm/Group Description:

FDA approved drug used in single arm study

intranasal ketorolac: 15 mg

Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Reported Pain Score of 10
10
  27.0%
Reported Pain Score of 9
2
   5.4%
Reported Pain Score of 8
12
  32.4%
Reported Pain Score of 7
5
  13.5%
Reported Pain Score of 6
5
  13.5%
Reported Pain Score of 5
1
   2.7%
Reported Pain Score of 4
2
   5.4%
REported Pain Score of 3
0
   0.0%
Reported Pain Score of 2
0
   0.0%
Reported Pain Score of 1
0
   0.0%
Reported Pain Score of 0
0
   0.0%
No Rating
0
   0.0%
20 minutes Reported Pain Score of 10
3
   8.1%
Reported Pain Score of 9
2
   5.4%
Reported Pain Score of 8
3
   8.1%
Reported Pain Score of 7
2
   5.4%
Reported Pain Score of 6
2
   5.4%
Reported Pain Score of 5
6
  16.2%
Reported Pain Score of 4
3
   8.1%
REported Pain Score of 3
4
  10.8%
Reported Pain Score of 2
5
  13.5%
Reported Pain Score of 1
3
   8.1%
Reported Pain Score of 0
4
  10.8%
No Rating
0
   0.0%
40 minutes Reported Pain Score of 10
2
   5.4%
Reported Pain Score of 9
3
   8.1%
Reported Pain Score of 8
3
   8.1%
Reported Pain Score of 7
1
   2.7%
Reported Pain Score of 6
1
   2.7%
Reported Pain Score of 5
3
   8.1%
Reported Pain Score of 4
2
   5.4%
REported Pain Score of 3
1
   2.7%
Reported Pain Score of 2
4
  10.8%
Reported Pain Score of 1
1
   2.7%
Reported Pain Score of 0
6
  16.2%
No Rating
10
  27.0%
1 hour Reported Pain Score of 10
1
   2.7%
Reported Pain Score of 9
0
   0.0%
Reported Pain Score of 8
1
   2.7%
Reported Pain Score of 7
0
   0.0%
Reported Pain Score of 6
0
   0.0%
Reported Pain Score of 5
1
   2.7%
Reported Pain Score of 4
0
   0.0%
REported Pain Score of 3
1
   2.7%
Reported Pain Score of 2
1
   2.7%
Reported Pain Score of 1
0
   0.0%
Reported Pain Score of 0
3
   8.1%
No Rating
29
  78.4%
2 hoiurs Reported Pain Score of 10
0
   0.0%
Reported Pain Score of 9
0
   0.0%
Reported Pain Score of 8
1
   2.7%
Reported Pain Score of 7
0
   0.0%
Reported Pain Score of 6
0
   0.0%
Reported Pain Score of 5
0
   0.0%
Reported Pain Score of 4
0
   0.0%
REported Pain Score of 3
0
   0.0%
Reported Pain Score of 2
0
   0.0%
Reported Pain Score of 1
0
   0.0%
Reported Pain Score of 0
0
   0.0%
No Rating
36
  97.3%
3 hours Reported Pain Score of 10
0
   0.0%
Reported Pain Score of 9
1
   2.7%
Reported Pain Score of 8
0
   0.0%
Reported Pain Score of 7
0
   0.0%
Reported Pain Score of 6
0
   0.0%
Reported Pain Score of 5
0
   0.0%
Reported Pain Score of 4
0
   0.0%
REported Pain Score of 3
0
   0.0%
Reported Pain Score of 2
0
   0.0%
Reported Pain Score of 1
0
   0.0%
Reported Pain Score of 0
0
   0.0%
No Rating
36
  97.3%
4 hours Reported Pain Score of 10
0
   0.0%
Reported Pain Score of 9
0
   0.0%
Reported Pain Score of 8
0
   0.0%
Reported Pain Score of 7
0
   0.0%
Reported Pain Score of 6
0
   0.0%
Reported Pain Score of 5
0
   0.0%
Reported Pain Score of 4
0
   0.0%
REported Pain Score of 3
0
   0.0%
Reported Pain Score of 2
0
   0.0%
Reported Pain Score of 1
0
   0.0%
Reported Pain Score of 0
0
   0.0%
No Rating
37
 100.0%
2.Secondary Outcome
Title Adverse Event/Side Effects
Hide Description Safety assessed by reporting of all adverse events and side effects.
Time Frame Up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who reported discomfort or unpleasant feeling associated with use of intranasal ketorolac
Arm/Group Title Intranasal Ketorolac (Sprix)
Hide Arm/Group Description:

FDA approved drug used in single arm study

intranasal ketorolac: 15 mg

Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
Reported a "burning" feeling
7
  18.9%
No adverse event/Side effect reported
30
  81.1%
Time Frame 7 months
Adverse Event Reporting Description Definition same as Clinicaltrials.gov.
 
Arm/Group Title Intranasal Ketorolac (Sprix)
Hide Arm/Group Description

FDA approved drug used in single arm study

intranasal ketorolac: 15 mg

All-Cause Mortality
Intranasal Ketorolac (Sprix)
Affected / at Risk (%)
Total   0/37 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intranasal Ketorolac (Sprix)
Affected / at Risk (%) # Events
Total   0/37 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intranasal Ketorolac (Sprix)
Affected / at Risk (%) # Events
Total   7/37 (18.92%)    
Skin and subcutaneous tissue disorders   
Discomfort (burning feeling of nasal mucosa) * 1 [1]  7/37 (18.92%)  7
1
Term from vocabulary, SNOMED CT
*
Indicates events were collected by non-systematic assessment
[1]
7 individual felt discomfort (a burning feeling) of the nasal mucosa. This resolved quickly, within minutes. Inspection of the nasal mucosa showed no visible abnormalities.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sharon Mace MD
Organization: Cleveland Clinic Healthcare System
Phone: 216-445-4598
EMail: maces@ccf.org
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01471639     History of Changes
Other Study ID Numbers: LUI-S4
First Submitted: November 4, 2011
First Posted: November 15, 2011
Results First Submitted: April 17, 2017
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017