Phase 4
N=110
Intramuscular Ketorolac at Two Single-Dose Regimens
Musculoskeletal Pain · Analgesia · Adverse Event
Bottom Line
View on ClinicalTrials.gov: NCT04763876 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Mean Difference of Visual Analog Scale Scores — -29.74; -29.85 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketorolac Injection 15 mg (Drug); Ketorolac Injection 60 mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- William Beaumont Army Medical Center
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference of Visual Analog Scale Scores |
-18.99; -17.31 | — |
| SECONDARY Mean Difference of Visual Analog Scale Scores |
-18.99; -17.31 | — |
| SECONDARY Number of Participants With Adverse Events Related to the Administration of Ketorolac |
1; 9 | — |
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
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 180 mmHg
- Pulse rate 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).
Data sourced from ClinicalTrials.gov (NCT04763876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.