NCT04763876

Intramuscular Ketorolac at Two Single-Dose Regimens

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: William Beaumont Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Ketorolac Injection 15 mg	A single dose of 15 mg ketorolac administered intramuscularly.
DRUG	Ketorolac Injection 60 mg	A single dose of 60 mg ketorolac administered intramuscularly.

Timeline

• Start date: 2020-06-27
• Primary completion: 2020-11-09
• Completion: 2021-02-04
• First posted: 2021-02-21
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study