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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg ketorolac intramuscular | Active Comparator | Patients who received a single 15 mg dose of ketorolac administered intramuscularly |
|
| 60 mg ketorolac intramuscular | Active Comparator | Patients who received a single 60 mg dose of ketorolac administered intramuscularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Injection 15 mg | Drug | A single dose of 15 mg ketorolac administered intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 minutes from administration of medication |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel J Turner, MPAS | Department of Emergency Medicine, William Beaumont Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Army Medical Center | El Paso | Texas | 79920 | United States |
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For the duration of our study, no study subjects were excluded or disenrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 15 mg Ketorolac Intramuscular | Patients who received a single 15 mg dose of ketorolac administered intramuscularly Ketorolac Injection 15 mg: A single dose of 15 mg ketorolac administered intramuscularly. |
| FG001 | 60 mg Ketorolac Intramuscular | Patients who received a single 60 mg dose of ketorolac administered intramuscularly Ketorolac Injection 60 mg: A single dose of 60 mg ketorolac administered intramuscularly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 15 mg Ketorolac Intramuscular | Patients who received a single 15 mg dose of ketorolac administered intramuscularly Ketorolac Injection 15 mg: A single dose of 15 mg ketorolac administered intramuscularly. |
| BG001 | 60 mg Ketorolac Intramuscular |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 60 minutes from administration of medication |
|
120 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 15 mg Ketorolac Intramuscular | Patients who received a single 15 mg dose of ketorolac administered intramuscularly Ketorolac Injection 15 mg: A single dose of 15 mg ketorolac administered intramuscularly. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning at site of injection | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathaniel James Turner | William Beaumont Army Medical Center Department of Emergency Medicine | 915-742-6228 | nathaniel.j.turner3.mil@mail.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2021 | Feb 18, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2021 | Feb 8, 2021 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2020 | Feb 18, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D000377 | Agnosia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Single blinded, randomized, non-inferiority
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The patient was unaware of the dosage of ketorolac they received.
| Ketorolac Injection 60 mg | Drug | A single dose of 60 mg ketorolac administered intramuscularly. |
|
|
| 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. | At time of administration, 30 minutes after administration, and 60 minutes after administration. |
Patients who received a single 60 mg dose of ketorolac administered intramuscularly Ketorolac Injection 60 mg: A single dose of 60 mg ketorolac administered intramuscularly. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight in kilograms | Mean | Full Range | kg |
|
| Duration of pain | Mean | Full Range | minutes |
|
Patients who received a single 60 mg dose of ketorolac administered intramuscularly Ketorolac Injection 60 mg: A single dose of 60 mg ketorolac administered intramuscularly. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 30 minutes from administration of medication |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At time of administration, 30 minutes after administration, and 60 minutes after administration. |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 1 |
| 55 |
| EG001 | 60 mg Ketorolac Intramuscular | Patients who received a single 60 mg dose of ketorolac administered intramuscularly Ketorolac Injection 60 mg: A single dose of 60 mg ketorolac administered intramuscularly. | 0 | 55 | 0 | 55 | 9 | 55 |
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006571 | Heterocyclic Compounds |