Intramuscular Ketorolac at Two Single-Dose Regimens

NCT ID: NCT04763876

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-27
• Study Completion Date: 2021-02-04

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

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.

Conditions

Musculoskeletal Pain; Analgesia; Adverse Event

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

15 mg ketorolac intramuscular

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

Group Type: ACTIVE_COMPARATOR

Ketorolac Injection 15 mg

Intervention Type: DRUG

A single dose of 15 mg ketorolac administered intramuscularly.

60 mg ketorolac intramuscular

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

Group Type: ACTIVE_COMPARATOR

Ketorolac Injection 60 mg

Intervention Type: DRUG

A single dose of 60 mg ketorolac administered intramuscularly.

Interventions

Ketorolac Injection 15 mg

A single dose of 15 mg ketorolac administered intramuscularly.

Intervention Type: DRUG

Ketorolac Injection 60 mg

A single dose of 60 mg ketorolac administered intramuscularly.

Intervention Type: DRUG

Other Intervention Names

toradol; ketorolac tromethamine; ketorolac; Toradol; ketorolac tromethamine; ketorolac

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

William Beaumont Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Edna Rath

Human Protections Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathaniel J Turner, MPAS

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency Medicine, William Beaumont Army Medical Center

Locations

William Beaumont Army Medical Center

El Paso, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

C.2019.088

Identifier Type: -

Identifier Source: org_study_id