Back to resultsDosing of Ketorolac in the Emergency Department
Primary Purpose
Acute Pain
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Inclusion Criteria:
> 18 y/o
Exclusion Criteria:
pregnant allergic other contraindication
Sites / Locations
- University of Missouri Health Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
0 mg
10 mg
30 mg
Arm Description
0 mg ketorolac - placebo
10 mg ketorolac - low dose ketorolac
30 mg ketorolac - usual dose ketorolac
Outcomes
Primary Outcome Measures
Intensity of pain
pain score on 0-10 scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03464461
First Posted
March 7, 2018
Last Updated
July 16, 2023
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03464461
Brief Title
Dosing of Ketorolac in the Emergency Department
Official Title
Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
4 groups with 3 different treatments
Masking
ParticipantCare Provider
Masking Description
blinded drug
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0 mg
Arm Type
Placebo Comparator
Arm Description
0 mg ketorolac - placebo
Arm Title
10 mg
Arm Type
Active Comparator
Arm Description
10 mg ketorolac - low dose ketorolac
Arm Title
30 mg
Arm Type
Active Comparator
Arm Description
30 mg ketorolac - usual dose ketorolac
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Use of placebo, low, usual dose ketorolac
Intervention Description
IV drug
Primary Outcome Measure Information:
Title
Intensity of pain
Description
pain score on 0-10 scale
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 18 y/o
Exclusion Criteria:
pregnant allergic other contraindication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Robinson, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dosing of Ketorolac in the Emergency Department
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