Dosing of Ketorolac in the Emergency Department

NCT ID: NCT03464461

Last Updated: 2024-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2024-05-30

Brief Summary

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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

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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.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 groups with 3 different treatments
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
blinded drug

Study Groups

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0 mg

0 mg ketorolac - placebo

Group Type PLACEBO_COMPARATOR

Ketorolac

Intervention Type DRUG

IV drug

10 mg

10 mg ketorolac - low dose ketorolac

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

IV drug

30 mg

30 mg ketorolac - usual dose ketorolac

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

IV drug

Interventions

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Ketorolac

IV drug

Intervention Type DRUG

Other Intervention Names

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Use of placebo, low, usual dose ketorolac

Eligibility Criteria

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Inclusion Criteria

\> 18 y/o

Exclusion Criteria

pregnant allergic other contraindication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Matthew Robinson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri Health Care

Columbia, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2010856

Identifier Type: -

Identifier Source: org_study_id

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