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Dosing of Ketorolac in the Emergency Department

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03464461
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : May 18, 2022
Information provided by (Responsible Party):
Matthew Robinson, University of Missouri-Columbia

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
Acute Pain Drug: Ketorolac 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
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
Official Title: Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
Placebo Comparator: 0 mg
0 mg ketorolac - placebo
Drug: Ketorolac
IV drug
Other Name: Use of placebo, low, usual dose ketorolac

Active Comparator: 10 mg
10 mg ketorolac - low dose ketorolac
Drug: Ketorolac
IV drug
Other Name: Use of placebo, low, usual dose ketorolac

Active Comparator: 30 mg
30 mg ketorolac - usual dose ketorolac
Drug: Ketorolac
IV drug
Other Name: Use of placebo, low, usual dose ketorolac

Primary Outcome Measures :
  1. Intensity of pain [ Time Frame: 30 minutes ]
    pain score on 0-10 scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

> 18 y/o

Exclusion Criteria:

pregnant allergic other contraindication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03464461

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Contact: Matthew Robinson, MD 5738824141
Contact: Julie Stilley, PhD 5738824141

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United States, Missouri
University of Missouri Health Care Recruiting
Columbia, Missouri, United States, 65212
Contact: John Yanos, MD         
Sponsors and Collaborators
University of Missouri-Columbia
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Principal Investigator: Matthew Robinson, MD University of Missouri-Columbia
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Responsible Party: Matthew Robinson, Associate Professor, University of Missouri-Columbia Identifier: NCT03464461    
Other Study ID Numbers: 2010856
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Acute Pain
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action