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Dosing of Ketorolac in the Emergency Department

Sponsor
University of Missouri-Columbia (Other)
Overall Status
Recruiting
CT.gov ID
NCT03464461
Collaborator
(none)
700
Enrollment
1
Location
3
Arms
87
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
4 groups with 3 different treatments4 groups with 3 different treatments
Masking:
Double (Participant, Care Provider)
Masking Description:
blinded drug
Primary Purpose:
Treatment
Official Title:
Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department
Actual Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 0 mg

0 mg ketorolac - placebo

Drug: Ketorolac
IV drug
Other Names:
  • Use of placebo, low, usual dose ketorolac

    		•
    Active Comparator: 10 mg

    10 mg ketorolac - low dose ketorolac

    Drug: Ketorolac
    IV drug
    Other Names:
  • Use of placebo, low, usual dose ketorolac

    		•
    Active Comparator: 30 mg

    30 mg ketorolac - usual dose ketorolac

    Drug: Ketorolac
    IV drug
    Other Names:
  • Use of placebo, low, usual dose ketorolac

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intensity of pain [30 minutes]

      pain score on 0-10 scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    18 y/o

    Exclusion Criteria:

    pregnant allergic other contraindication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Missouri Health Care Columbia Missouri United States 65212

    Sponsors and Collaborators

    • University of Missouri-Columbia

    Investigators

    • Principal Investigator: Matthew Robinson, MD, University of Missouri-Columbia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matthew Robinson, Associate Professor, University of Missouri-Columbia
    ClinicalTrials.gov Identifier:
    NCT03464461
    Other Study ID Numbers:
    • 2010856
    First Posted:
    Mar 14, 2018
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Emergencies
    Acute Pain
    Ketorolac
    Ketorolac Tromethamine

    Study Results

    No Results Posted as of May 18, 2022