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Trial record 18 of 415 for:    KETOROLAC

Dosing of Ketorolac in the Emergency Department

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ClinicalTrials.gov Identifier: NCT03464461
Recruitment Status : Not yet recruiting
First Posted : March 14, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
John Yanos, 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.

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
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : August 1, 2019

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. pain [ Time Frame: 30 minutes ]
    pain score on 0-10 scale



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

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 ClinicalTrials.gov identifier (NCT number): NCT03464461


Contacts
Contact: John Yanos, MD 5738824141 yanos@missouri.edu
Contact: Matthew Robinson, MD 5738824141 robinsonm@missouri.edu

Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: John Yanos, MD University of Missouri-Columbia

Responsible Party: John Yanos, Associate Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03464461     History of Changes
Other Study ID Numbers: 2010856
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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