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Dosing of Ketorolac in the Emergency Department

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ClinicalTrials.gov Identifier: NCT03464461
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Matthew Robinson, University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE March 14, 2018
Last Update Posted Date May 18, 2022
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
Intensity of pain [ Time Frame: 30 minutes ]
pain score on 0-10 scale
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
pain [ Time Frame: 30 minutes ]
pain score on 0-10 scale
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dosing of Ketorolac in the Emergency Department
Official Title  ICMJE Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department
Brief Summary The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.
Detailed Description Patients from 4 groups will be treated with 3 different doses of ketorolac. The groups are 1. headache 2. abdominal pain 3. musculo-skeletal pain 4. viral syndrome. The doses will be 0, 10, 30mgs of ketorolac to clarify the placebo effect and the optimal dosage as a function of condition.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
4 groups with 3 different treatments
Masking: Double (Participant, Care Provider)
Masking Description:
blinded drug
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE Drug: Ketorolac
IV drug
Other Name: Use of placebo, low, usual dose ketorolac
Study Arms  ICMJE
  • Placebo Comparator: 0 mg
    0 mg ketorolac - placebo
    Intervention: Drug: Ketorolac
  • Active Comparator: 10 mg
    10 mg ketorolac - low dose ketorolac
    Intervention: Drug: Ketorolac
  • Active Comparator: 30 mg
    30 mg ketorolac - usual dose ketorolac
    Intervention: Drug: Ketorolac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2018)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2025
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

> 18 y/o

Exclusion Criteria:

pregnant allergic other contraindication

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthew Robinson, MD 5738824141 robinsonm@missouri.edu
Contact: Julie Stilley, PhD 5738824141 stilleyj@health.missouri.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03464461
Other Study ID Numbers  ICMJE 2010856
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Matthew Robinson, University of Missouri-Columbia
Original Responsible Party John Yanos, University of Missouri-Columbia, Associate Professor
Current Study Sponsor  ICMJE University of Missouri-Columbia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew Robinson, MD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP