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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01471639
First Posted: November 15, 2011
Last Update Posted: September 12, 2017
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.
Collaborator:
Luitpold Pharmaceuticals
Information provided by (Responsible Party):
The Cleveland Clinic
Results First Submitted: April 17, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
December 01, 2011 Emergency Department

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Chronic pain, critical illness

Reporting Groups
  Description
Intranasal Ketorolac (Sprix)

FDA approved drug used in single arm study

intranasal ketorolac: 15 mg


Participant Flow:   Overall Study
    Intranasal Ketorolac (Sprix)
STARTED   37 
COMPLETED   37 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intranasal Ketorolac (Sprix)

FDA approved drug used in single arm study

intranasal ketorolac: 15 mg


Baseline Measures
   Intranasal Ketorolac (Sprix) 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      37 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.2  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      23  62.2% 
Male      14  37.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   2.7% 
Not Hispanic or Latino      34  91.9% 
Unknown or Not Reported      2   5.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
 
United States   37 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy of Intranasal Ketorolac on Numeric Pain Scale   [ Time Frame: up to 4 hours ]

2.  Secondary:   Adverse Event/Side Effects   [ Time Frame: Up to 4 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: maces@ccf.org


Publications:

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