Musculoskeletal PainPhase 4NCT04763876
Intramuscular Ketorolac at Two Single-Dose Regimens
A Phase 4 study testing Ketorolac Injection 15 mg and Ketorolac Injection 60 mg in people with Musculoskeletal Pain and Analgesia, run by William Beaumont Army Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Analgesia, Adverse Event
- What is being tested?
- Ketorolac Injection 15 mg and Ketorolac Injection 60 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2020to 4 Feb 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Army Medical Center
El Paso, Texas, 79920
About this study
Official title: 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
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
Read the 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
- Being tested
- Ketorolac Injection 15 mg, Ketorolac Injection 60 mg
- Keywords
- emergency department, ketorolac, musculoskeletal pain, non-inferiority, adverse event
- Medical subject headings
- Musculoskeletal Pain, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac Injection 15 mgDrug
Also called toradol, ketorolac tromethamine, ketorolac
A single dose of 15 mg ketorolac administered intramuscularly.
Ketorolac Injection 60 mgDrug
Also called Toradol, ketorolac tromethamine, ketorolac
A single dose of 60 mg ketorolac administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| 15 mg ketorolac intramuscular | Active comparator | Patients who received a single 15 mg dose of ketorolac administered intramuscularly Receives: Drug: Ketorolac Injection 15 mg |
| 60 mg ketorolac intramuscular | Active comparator | Patients who received a single 60 mg dose of ketorolac administered intramuscularly Receives: Drug: Ketorolac Injection 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes from administration of medication
Secondary outcomes (2)
Mean Difference of Visual Analog Scale Scores
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.
Measured: 30 minutes from administration of medication
Number of Participants With Adverse Events Related to the Administration of Ketorolac
The incidence of observed objective and reported subjective adverse events related to the administration of ketorolac.
Measured: At time of administration, 30 minutes after administration, and 60 minutes after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start27 Jun 2020
- Primary completion9 Nov 2020
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded, randomized, non-inferiority
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Beaumont Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Edna Rath, William Beaumont Army Medical Center
- Investigators
- Nathaniel J Turner, MPAS, Principal investigator, Department of Emergency Medicine, William Beaumont Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763876
- Sponsor's protocol ID
- C.2019.088
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2021
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04763876
- Acronym / sponsor ID
- C.2019.088
- Conditions
- Musculoskeletal Pain, Analgesia, Adverse Event
- Keywords
- emergency department, ketorolac, musculoskeletal pain, non-inferiority, adverse event
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- William Beaumont Army Medical CenterUS federal agency
- Study start
- 27 Jun 2020 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded, randomized, non-inferiority
| Arm | Type | Receives |
|---|---|---|
| 15 mg ketorolac intramuscular | Active comparator | Drug: Ketorolac Injection 15 mgPatients who received a single 15 mg dose of ketorolac administered intramuscularly |
| 60 mg ketorolac intramuscular | Active comparator | Drug: Ketorolac Injection 60 mgPatients who received a single 60 mg dose of ketorolac administered intramuscularly |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac Injection 15 mgAlso: toradol, ketorolac tromethamine, ketorolacA single dose of 15 mg ketorolac administered intramuscularly. | Drug | 15 mg ketorolac intramuscular |
| Ketorolac Injection 60 mgAlso: Toradol, ketorolac tromethamine, ketorolacA single dose of 60 mg ketorolac administered intramuscularly. | Drug | 60 mg ketorolac intramuscular |
Primary outcome
Mean Difference of Visual Analog Scale Scores
Time frame: 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.
2 secondary outcomes
Mean Difference of Visual Analog Scale Scores
Time frame: 30 minutes from administration of medication
Number of Participants With Adverse Events Related to the Administration of Ketorolac
Time frame: At time of administration, 30 minutes after administration, and 60 minutes after administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel J Turner, MPAS principal investigator
Department of Emergency Medicine, William Beaumont Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac Injection 15 mg and Ketorolac Injection 60 mg in people with Musculoskeletal Pain and Analgesia, run by William Beaumont Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference of Visual Analog Scale Scores (time frame: 60 minutes from administration of medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.