Not provided
Not provided
Not provided
Not provided
Not provided
Pandemic related supply shortages and slowed enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.
Patients from 4 groups will be treated with 3 different doses of ketorolac. The groups are 1. headache 2. abdominal pain 3. musculo-skeletal pain 4. viral syndrome. The doses will be 0, 10, 30mgs of ketorolac to clarify the placebo effect and the optimal dosage as a function of condition.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 mg | Placebo Comparator | 0 mg ketorolac - placebo |
|
| 10 mg | Active Comparator | 10 mg ketorolac - low dose ketorolac |
|
| 30 mg | Active Comparator | 30 mg ketorolac - usual dose ketorolac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | IV drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type | The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible. | 30 minutes |
| Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain | The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible. | 30 minutes |
| Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache | The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible. |
Not provided
Not provided
Inclusion Criteria:
> 18 y/o
Exclusion Criteria:
pregnant allergic other contraindication
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew Robinson, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were excluded if they were giving medications that could interfere with study results, if study medication could not be administered, at the providers discretion, or if the participant decided to withdraw from the study.
31 participants signed consent but withdrew/were excluded before study drug administration 4 participants were excluded after study drug administration (see below)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0 mg | 0 mg ketorolac - placebo Ketorolac: IV drug |
| FG001 | 10 mg | 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug |
| FG002 | 30 mg | 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0 mg | 0 mg ketorolac - placebo Ketorolac: IV drug |
| BG001 | 10 mg | 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type | The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible. | Patients presenting to the Emergency Department with pain that falls in one of the for categories: abdominal, headache, trauma/musculoskeletal, viral | Posted | Mean | Standard Deviation | mm | 30 minutes |
|
Approximately 40 minutes, from the time of consent until post-treatment pain score was obtained
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0 mg | 0 mg ketorolac - placebo Ketorolac: IV drug | 0 |
Not provided
Not provided
Study enrollment ended early, resulting in less than half of the number of participants needed according to the power analysis. Our study site was closed to enrollment during the recent pandemic, and there was major supply chain issues for saline and IV equipment. Ultimately the study was closed due to the extenuating circumstances.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Robinson | University of Missouri | 573 884-4400 | robinsonmt@health.missouri.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2021 | Oct 15, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 9, 2022 | Aug 28, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
4 groups with 3 different treatments
Not provided
Not provided
blinded drug
| 30 minutes |
| Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain | The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible. | 30 min |
| Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain | The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible. | 30 min |
| BG002 | 30 mg | 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| Baseline Pain Score | The average number of millimeters measured from the 0mm end of the 100mm long Visual Analog Scale (VAS) line to the mark on the line made by the participants indicating their pain level before given the study treatment. | Mean | Standard Deviation | millimeters (mm) |
|
| 0 mg |
0 mg ketorolac - placebo Ketorolac: IV drug |
| OG001 | 10 mg | 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug |
| OG002 | 30 mg | 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug |
|
|
|
| Primary | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain | The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible. | Patients presenting to the Emergency Department with abdominal pain | Posted | Mean | Standard Deviation | mm | 30 minutes |
|
|
|
|
| Primary | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache | The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible. | Patients presenting to the Emergency Department with headache | Posted | Mean | Standard Deviation | mm | 30 minutes |
|
|
|
|
| Primary | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain | The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible. | Patients presenting to the Emergency Department with trauma/musculoskeletal pain | Posted | Mean | Standard Deviation | mm | 30 min |
|
|
|
|
| Primary | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain | The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible. | Patients presenting to the Emergency Department with viral pain | Posted | Mean | Standard Deviation | mm | 30 min |
|
|
|
|
| 82 |
| 0 |
| 82 |
| 0 |
| 82 |
| EG001 | 10 mg | 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug | 0 | 89 | 0 | 89 | 0 | 89 |
| EG002 | 30 mg | 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug | 0 | 83 | 0 | 83 | 0 | 83 |
Not provided
Not provided
Not provided
| D006571 | Heterocyclic Compounds |
| Male |
|