Dosing of Ketorolac in the Emergency Department

Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department

The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.

Study Overview

• Status: Terminated
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Ketorolac

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
• Enrollment (Actual): 289
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

> 18 y/o

Exclusion Criteria:

pregnant allergic other contraindication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type	The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.	30 minutes
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain	The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.	30 minutes
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache	The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.	30 minutes
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain	The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.	30 min
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain	The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.	30 min

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Ketorolac; Ketorolac Tromethamine
• Other Study ID Numbers: 2010856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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