Acute Pain
Conditions
Brief summary
The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.
Detailed description
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.
Interventions
DRUGKetorolac
IV drug
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
blinded drug
Intervention model description
4 groups with 3 different treatments
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\> 18 y/o
Exclusion criteria
pregnant allergic other contraindication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type | 30 minutes | 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. |
| Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain | 30 minutes | 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. |
| Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache | 30 minutes | 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. |
| Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain | 30 min | 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. |
| Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain | 30 min | 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. |
Countries
United States
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 0 mg 0 mg ketorolac - placebo
Ketorolac: IV drug | 82 |
| 10 mg 10 mg ketorolac - low dose ketorolac
Ketorolac: IV drug | 89 |
| 30 mg 30 mg ketorolac - usual dose ketorolac
Ketorolac: IV drug | 83 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | exclusionary medication given , | 1 | 2 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 0 mg | 10 mg | 30 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 17 | 44 years STANDARD_DEVIATION 16 | 41 years STANDARD_DEVIATION 16 | 43 years STANDARD_DEVIATION 16 |
| Baseline Pain Score | 67.2 millimeters (mm) STANDARD_DEVIATION 15.1 | 65.3 millimeters (mm) STANDARD_DEVIATION 15.6 | 66.4 millimeters (mm) STANDARD_DEVIATION 16.7 | 66.30 millimeters (mm) STANDARD_DEVIATION 21.39 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 82 participants | 89 participants | 83 participants | 254 participants |
| Sex: Female, Male Female | 31 Participants | 51 Participants | 46 Participants | 128 Participants |
| Sex: Female, Male Male | 51 Participants | 38 Participants | 37 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 89 | 0 / 83 |
| other Total, other adverse events | 0 / 82 | 0 / 89 | 0 / 83 |
| serious Total, serious adverse events | 0 / 82 | 0 / 89 | 0 / 83 |
Outcome results
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.
Time frame: 30 minutes
Population: Patients presenting to the Emergency Department with abdominal pain
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain | 12.4 mm | Standard Deviation 16.5 |
| 10 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain | 19.4 mm | Standard Deviation 19.9 |
| 30 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain | 22.1 mm | Standard Deviation 21 |
p-value: 0.158Kruskal-Wallis
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.
Time frame: 30 minutes
Population: Patients presenting to the Emergency Department with pain that falls in one of the for categories: abdominal, headache, trauma/musculoskeletal, viral
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type | 15.1 mm | Standard Deviation 18.5 |
| 10 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type | 15.6 mm | Standard Deviation 19.4 |
| 30 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type | 16.7 mm | Standard Deviation 20.7 |
p-value: 0.9844Kruskal-Wallis
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.
Time frame: 30 minutes
Population: Patients presenting to the Emergency Department with headache
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache | 13.3 mm | Standard Deviation 14.8 |
| 10 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache | 10.8 mm | Standard Deviation 8.7 |
| 30 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache | 11.1 mm | Standard Deviation 18.4 |
p-value: 0.873Kruskal-Wallis
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.
Time frame: 30 min
Population: Patients presenting to the Emergency Department with trauma/musculoskeletal pain
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain | 16.5 mm | Standard Deviation 21 |
| 10 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain | 5.4 mm | Standard Deviation 15.6 |
| 30 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain | 10.0 mm | Standard Deviation 19 |
p-value: 0.074Kruskal-Wallis
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.
Time frame: 30 min
Population: Patients presenting to the Emergency Department with viral pain
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain | 21.8 mm | Standard Deviation 19.3 |
| 10 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain | 25.4 mm | Standard Deviation 17.5 |
| 30 mg | Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain | 8.4 mm | Standard Deviation 15.7 |
p-value: 0.0984Kruskal-Wallis