Intramuscular Ketorolac at Two Single-Dose Regimens

September 25, 2025 updated by: Edna Rath, William Beaumont Army Medical Center

Comparison of Intramuscular Ketorolac at Two Single-Dose Regimens for Treatment of Acute Musculoskeletal Pain in a Military Emergency Department: A Randomized Controlled Non-Inferiority Trial

The purpose of this study was to evaluate a single 15 mg intramuscular (IM) dose of ketorolac for analgesic non-inferiority versus a single 60 mg IM dose for the treatment of acute MSK pain in a military emergency department (ED) that services Department of Defense (DoD), Department of Veteran Affairs (VA), and foreign military beneficiaries

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary purpose of this study is to evaluate a single 15 mg IM dose of ketorolac for analgesic non-inferiority versus a single 60 mg IM dose for the treatment of acute MSK pain in a military ED that services Department of Defense (DoD), Department of Veteran Affairs (VA), and foreign military beneficiaries. The authors chose to evaluate 15 mg rather than the previously identified 10 mg dose for ease of administration as ketorolac is manufactured in 15 mg/mL, 30 mg/mL, and 60 mg/2mL vials in the U.S. The dose of ketorolac served as the primary independent variable for the study and the change in Visual Analog Scale (VAS) score served as the dependent variable. Prescribing the minimally effective doses of NSAIDs is pertinent to prevent and reduce the number of adverse events. Thus, the secondary outcome assessed for the dose-dependence of subjective and objective adverse events with ketorolac.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79920
        • William Beaumont Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Tricare beneficiaries between 18-55 years of age
  • Triaged as Emergency Severity Index 4 or 5
  • Presenting to the William Beaumont Army Medical Center Emergency Department with a chief complaint of acute MSK pain (i.e., general muscular, neck, back, shoulder, arm, forearm, elbow, wrist, finger, hip, knee, thigh, leg, ankle, foot, or digits)
  • Pain intensity of 20 mm or greater on a standard 100 mm visual analog scale
  • Who the attending provider concurred with ketorolac IM administration for analgesia.

Exclusion Criteria:

  • Body weight less than 50 kg (110 lbs.)
  • Younger than 18 or older than 55 years
  • Pregnant or breast feeding
  • History of: confirmed, unconfirmed, known, unknown, or suspected peptic ulcer disease, intestinal hemorrhage, renal insufficiency, hepatic insufficiency, cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, dark stools, bright red blood per rectum, hemoptysis, easy bruising, or high risk of bleeding
  • Unable to confidently convey or unknown medical history
  • Allergy or hypersensitivity to nonsteroidal anti-inflammatory drugs or aspirin
  • Systolic blood pressure <90 or >180 mmHg
  • Pulse rate <50 or >150 beats/min
  • Any over-the-counter or prescribed opioid and/or non-opioid analgesic medication (oral, per rectum, topical or parenteral) taken within 12 hours of ED presentation
  • Advised by any medical provider to not receive NSAIDs for any reason
  • Pain duration greater than 30 days (including acute on chronic pain)
  • Refusal to remain in the WBAMC ED for up to 60 minutes after injection of ketorolac
  • Patients currently taking anticoagulant medications
  • Concurrent use of medications which are contraindicated with concomitant NSAID use (drugs include aspirin, probenecid and pentoxifylline).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 15 mg ketorolac intramuscular
Patients who received a single 15 mg dose of ketorolac administered intramuscularly
Drug: Ketorolac Injection 15 mg
A single dose of 15 mg ketorolac administered intramuscularly.
Other Names:
  • ketorolac
  • toradol
  • ketorolac tromethamine
Active Comparator: 60 mg ketorolac intramuscular
Patients who received a single 60 mg dose of ketorolac administered intramuscularly
Drug: Ketorolac Injection 60 mg
A single dose of 60 mg ketorolac administered intramuscularly.
Other Names:
  • ketorolac
  • Toradol
  • ketorolac tromethamine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Difference of Visual Analog Scale Scores
Time Frame: 60 minutes from administration of medication
The mean difference of Visual Analog Scale scores between the two treatment groups measured at 60-minutes. The Visual Analog Scale used measures from 0 mm to 100mm. A higher score represents more degree of change. 13 mm was used as the non-inferiority margin. A difference between the two groups less than 13 mm demonstrates that 15 mg is non-inferior to 60 mg.
60 minutes from administration of medication

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Difference of Visual Analog Scale Scores
Time Frame: 30 minutes from administration of medication
The mean difference of Visual Analog Scale scores between the two treatment groups measured at 30-minutes. The Visual Analog Scale used measures from 0 mm to 100mm. A higher score represents more degree of change. 13 mm was used as the non-inferiority margin. A difference between the two groups less than 13 mm demonstrates that 15 mg is non-inferior to 60 mg.
30 minutes from administration of medication
Number of Participants With Adverse Events Related to the Administration of Ketorolac
Time Frame: At time of administration, 30 minutes after administration, and 60 minutes after administration.
The incidence of observed objective and reported subjective adverse events related to the administration of ketorolac.
At time of administration, 30 minutes after administration, and 60 minutes after administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
William Beaumont Army Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathaniel J Turner, MPAS, Department of Emergency Medicine, William Beaumont Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C.2019.088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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