Intramuscular Ketorolac at Two Single-Dose Regimens

NCT04763876 | Completed Phase 4 Results FDA Drug

• 1 other identifier: C.2019.088
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Musculoskeletal Pain; Analgesia; Adverse Event

Keywords

emergency department; ketorolac; musculoskeletal pain; non-inferiority; adverse event

Outcome Measures

Primary Outcomes (1)

• Mean Difference of Visual Analog Scale Scores

  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 Outcomes (2)

• Mean Difference of Visual Analog Scale Scores

  30 minutes from administration of medication

• Number of Participants With Adverse Events Related to the Administration of Ketorolac

  At time of administration, 30 minutes after administration, and 60 minutes after administration.

Study Arms (2)

15 mg ketorolac intramuscular

ACTIVE COMPARATOR

Patients who received a single 15 mg dose of ketorolac administered intramuscularly

Drug: Ketorolac Injection 15 mg

60 mg ketorolac intramuscular

ACTIVE COMPARATOR

Patients who received a single 60 mg dose of ketorolac administered intramuscularly

Drug: Ketorolac Injection 60 mg

Interventions

Ketorolac Injection 15 mg DRUG

A single dose of 15 mg ketorolac administered intramuscularly.

Also known as: toradol, ketorolac tromethamine, ketorolac

15 mg ketorolac intramuscular

Ketorolac Injection 60 mg DRUG

A single dose of 60 mg ketorolac administered intramuscularly.

Also known as: Toradol, ketorolac tromethamine, ketorolac

60 mg ketorolac intramuscular

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• William Beaumont Army Medical Center: lead

Study Sites (1)

William Beaumont Army Medical Center

El Paso, Texas, 79920, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Agnosia; Emergencies

Interventions

Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Nathaniel James Turner
• Organization: William Beaumont Army Medical Center Department of Emergency Medicine

nathaniel.j.turner3.mil@mail.mil

915-742-6228

Study Officials

• Nathaniel J Turner, MPAS

  Department of Emergency Medicine, William Beaumont Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient was unaware of the dosage of ketorolac they received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Human Protections Director

Model Details: Single blinded, randomized, non-inferiority

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 21, 2021
• Study Start: June 27, 2020
• Primary Completion: November 9, 2020
• Study Completion: February 4, 2021
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)