NCT04763876 is a Phase 4 clinical trial of Ketorolac Injection 15 mg in Musculoskeletal Pain, sponsored by William Beaumont Army Medical Center.

Who is sponsoring NCT04763876?

NCT04763876 is sponsored by William Beaumont Army Medical Center.

What drugs are being tested in NCT04763876?

Interventions in NCT04763876: Ketorolac Injection 15 mg, Ketorolac Injection 60 mg.

What condition does NCT04763876 study?

NCT04763876 studies Musculoskeletal Pain, Analgesia, Adverse Event.

Is NCT04763876 still recruiting?

NCT04763876 is currently completed. Last updated 15 October 2025.

Are results published for NCT04763876?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-15 · How we verify

NCT04763876

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Intramuscular Ketorolac at Two Single-Dose Regimens

Completed Phase 4 Results posted Last updated 15 October 2025

What this trial tests

Phase 4 trial testing Ketorolac Injection 15 mg in Musculoskeletal Pain in 110 participants. Completed in 4 February 2021.

Timeline

27 June 2020

Primary endpoint
9 November 2020

4 February 2021

Quick facts

Lead sponsor	William Beaumont Army Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	110
Start date	27 June 2020
Primary completion	9 November 2020
Estimated completion	4 February 2021
Sites	1 location across United States

Drugs / interventions tested

Ketorolac Injection 15 mg — full drug profile →
Ketorolac Injection 60 mg — full drug profile →

Conditions studied

Musculoskeletal Pain — all drugs for Musculoskeletal Pain →
Analgesia — all drugs for Analgesia →
Adverse Event — all drugs for Adverse Event →

Sponsor

William Beaumont Army Medical Center

Who can join

Adults 18 to 55, any sex, with Musculoskeletal Pain or Analgesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Difference of Visual Analog Scale Scores Primary · 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.

Group	Value	95% CI
15 mg Ketorolac Intramuscular	-29.74	± 22.46
60 mg Ketorolac Intramuscular	-29.85	± 23.14

Mean Difference of Visual Analog Scale Scores Secondary · 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.

Group	Value	95% CI
15 mg Ketorolac Intramuscular	-18.99	± 17.73
60 mg Ketorolac Intramuscular	-17.31	± 18.31

Number of Participants With Adverse Events Related to the Administration of Ketorolac Secondary · 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.

Group	Value	95% CI
15 mg Ketorolac Intramuscular	1
60 mg Ketorolac Intramuscular	9

Adverse events — posted to ClinicalTrials.gov

Time frame: 120 minutes. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

15 mg Ketorolac Intramuscular

Serious: 0/55 (0%)

Deaths: 0/55

60 mg Ketorolac Intramuscular

Serious: 0/55 (0%)

Deaths: 0/55

Other adverse events (4 terms — click to expand)

Reaction	System	15 mg Ketorolac Intramuscu…	60 mg Ketorolac Intramuscu…
Burning at site of injection	Skin and subcutaneous tissue disorders	—	—
Fatigue	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Nausea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT04763876 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Musculoskeletal Pain

Currently open trials in the same condition.

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NCT07048366 — Mindfulness-based Rehabilitation in a University Museum Setting to Reduce Pain and Improve Quality of Life in Women With · NA · recruiting

Other William Beaumont Army Medical Center trials

Trials by the same sponsor.

NCT03905681 — TENS Efficacy on Acute Back Pain in an Emergency Department Triage · NA · completed
NCT03539588 — Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04763876 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by William Beaumont Army Medical Center
Last refreshed: 15 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04763876.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing