Pain
Conditions
Keywords
Post Operative Pain,, Pail relief
Brief summary
The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)
Interventions
DRUGIV ibuprofen
DRUGKetorolac
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for knee arthroscopy
Exclusion criteria
* Inadequate IV access. * History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors. * Less than 18 years of age. * Use of analgesics less than 8 hours prior to surgery. * Patients with active, clinically significant anemia. * History or evidence of asthma or heart failure. * Pregnant. * Recent history of chronic opioid use. * Concomitant use of probenecid. * Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions and to return for the required assessments. * Refusal to provide written authorization for use and disclosure of protected health information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Pain Relief (Pain Intensity at Rest) | First possible time post-surgery, an expected average of 6 hours | Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain). |
| Efficacy of Pain Relief (Pain Intensity With Movement) | First possible time post-surgery, an expected average of 6 hours | Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Medication Use in Post-operative Period | Post-operative period until discharge, an expected average of 6 hours | Amount of rescue medication (in milligrams) will be measured |
| Time to First Use of Rescue Med Will be Measured | Post-operative period until discharge, an expected average of 6 hours | Time to first rescue medication (in hours) in the postoperative period through discharge. |
| Patient Satisfaction | Post-operative period until discharge, an expected average of 6 hours | Measured using 2 question, 4 point scale. |
| Incidence of Serious Adverse Events | Post-operative period until discharge, an expected average of 6 hours | Number of subjects experiencing treatment-emergent serious adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Ibuprofen 800mg ibuprofen
IV ibuprofen | 51 |
| Ketorolac 30mg ketorolac
Ketorolac | 49 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | IV Ibuprofen | Total | Ketorolac |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 13.3 | 46 years STANDARD_DEVIATION 14.4 | 46 years STANDARD_DEVIATION 15.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 96 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 44 Participants | 92 Participants | 48 Participants |
| Region of Enrollment United States | 51 participants | 100 participants | 49 participants |
| Sex: Female, Male Female | 18 Participants | 39 Participants | 21 Participants |
| Sex: Female, Male Male | 33 Participants | 61 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 49 |
| serious Total, serious adverse events | 0 / 51 | 0 / 49 |
Outcome results
Primary
Efficacy of Pain Relief (Pain Intensity at Rest)
Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).
Time frame: First possible time post-surgery, an expected average of 6 hours
Population: This analysis was performed on all subject who completed the VAS at Rest Immediately Following their Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Ibuprofen | Efficacy of Pain Relief (Pain Intensity at Rest) | 30 units on a scale (in mm) | Standard Deviation 27 |
| Ketorolac | Efficacy of Pain Relief (Pain Intensity at Rest) | 32 units on a scale (in mm) | Standard Deviation 25.1 |
Primary
Efficacy of Pain Relief (Pain Intensity With Movement)
Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).
Time frame: First possible time post-surgery, an expected average of 6 hours
Population: This analysis was performed on all subject who completed the VAS with Movement Immediately Following their Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Ibuprofen | Efficacy of Pain Relief (Pain Intensity With Movement) | 32 units on a scale (in mm) | Standard Deviation 28 |
| Ketorolac | Efficacy of Pain Relief (Pain Intensity With Movement) | 41 units on a scale (in mm) | Standard Deviation 28.2 |
Secondary
Incidence of Serious Adverse Events
Number of subjects experiencing treatment-emergent serious adverse events
Time frame: Post-operative period until discharge, an expected average of 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Ibuprofen | Incidence of Serious Adverse Events | 0 Number of events |
| Ketorolac | Incidence of Serious Adverse Events | 0 Number of events |
Secondary
Patient Satisfaction
Measured using 2 question, 4 point scale.
Time frame: Post-operative period until discharge, an expected average of 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Ibuprofen | Patient Satisfaction | Poor | 0 Participants |
| IV Ibuprofen | Patient Satisfaction | Fair | 4 Participants |
| IV Ibuprofen | Patient Satisfaction | Good | 20 Participants |
| IV Ibuprofen | Patient Satisfaction | Excellent | 26 Participants |
| Ketorolac | Patient Satisfaction | Excellent | 22 Participants |
| Ketorolac | Patient Satisfaction | Poor | 1 Participants |
| Ketorolac | Patient Satisfaction | Good | 18 Participants |
| Ketorolac | Patient Satisfaction | Fair | 8 Participants |
Secondary
Rescue Medication Use in Post-operative Period
Amount of rescue medication (in milligrams) will be measured
Time frame: Post-operative period until discharge, an expected average of 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Ibuprofen | Rescue Medication Use in Post-operative Period | Narcotic | 13.7 milligrams | Standard Deviation 17.19 |
| IV Ibuprofen | Rescue Medication Use in Post-operative Period | Acetaminophen | 188.5 milligrams | Standard Deviation 255.06 |
| Ketorolac | Rescue Medication Use in Post-operative Period | Narcotic | 13.2 milligrams | Standard Deviation 16.5 |
| Ketorolac | Rescue Medication Use in Post-operative Period | Acetaminophen | 179.1 milligrams | Standard Deviation 248.77 |
Secondary
Time to First Use of Rescue Med Will be Measured
Time to first rescue medication (in hours) in the postoperative period through discharge.
Time frame: Post-operative period until discharge, an expected average of 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Ibuprofen | Time to First Use of Rescue Med Will be Measured | 1.2 hours | Standard Error 0.11 |
| Ketorolac | Time to First Use of Rescue Med Will be Measured | 1.2 hours | Standard Error 0.1 |