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The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.
Non-steroidal anti-inflammatory drugs(NSAIDs) are an effective adjunct to opioid analgesia for moderate-severe pain, with improvement in the quality of pain relief and consistent evidence of opioid dose sparing. NSAIDs alone could provide effective analgesia post-surgery when mild-moderate pain is expected. There is also evidence that the use of NSAIDs, by avoiding or decreasing the need for opioids, can lead to a reduction in the incidence of adverse events which are commonly attributed to, or exacerbated by, opioids.
The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV ibuprofen | Active Comparator | Intravenous ibuprofen (800 mg) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 (Ibuprofen arm) and a corresponding volume of normal saline (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure |
|
| IV ketorolac | Active Comparator | A corresponding volume of normal saline (Ibuprofen arm) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 and 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV ibuprofen | Drug | 800 mg intravenous ibuprofen administered intravenously over 10 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of IV Ibuprofen for Post-op Pain. | Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. 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 o and 100. | first possible assessment following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge | Measurement of the amount of rescue medication in the postoperative period. | 24 hours |
| Time to Discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando L Arbona, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University, Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30338261 | Derived | Uribe AA, Arbona FL, Flanigan DC, Kaeding CC, Palettas M, Bergese SD. Comparing the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain Following Arthroscopic Knee Surgery. A Randomized Double-Blind Active Comparator Pilot Study. Front Surg. 2018 Oct 3;5:59. doi: 10.3389/fsurg.2018.00059. eCollection 2018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Ibuprofen | 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes. |
| FG001 | IV Ketorolac | Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Intent-to-treat population consists of all patients who received at least a partial dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Ibuprofen | 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Subject greater than or equal to 18 years of age |
| 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 | Efficacy of IV Ibuprofen for Post-op Pain. | Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. 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 o and 100. | Posted | Mean | Standard Deviation | units on a scale | first possible assessment following surgery |
|
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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 | IV Ibuprofen | 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Rock, PhD | Cumberland Pharmaceutical Inc. | 615-255-0068 | arock@cumberlandpharma.com |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| IV ketorolac | Drug | 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds |
|
|
Measurement of the time to discharge in the postoperative period. |
| 24 hours |
| Patient Satisfaction. | Measurement of patient satisfaction post-procedure. During the post-treatment period, subjects were asked to complete a satisfaction questionnaire (Quality of Recovery - 40 or QoR-40) defining their quality of recovery at 24 hours following surgery. The QoR - 40 is a 40-item questionnaire that provides a global score and subscores across five dimensions of quality of recovery: emotions (minimum score = 6, maximum score = 30), physical comfort (minimum score = 8, maximum score = 40), patient support (minimum score = 7, maximum score = 35), physical independence (minimum score = 5, maximum score = 25), and pain (minimum score = 7, maximum score = 35). Higher subscores represent a better outcome. Subscores are added to create a Global QoR-40 score. Global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). | 24 hours |
| Incidence of Serious Adverse Events (SAEs). | Measurement of the incidence of serious adverse events. | 24 hours |
| Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours | Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) in the post-surgical period through 24 hours post-procedure. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject 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 and 100. Subject's were contacted at 24 hour post-discharge during a follow-up phone contact and asked to completed the VAS at Rest and VAS with Movement and return both completed VAS assessments via the envelope provided. The analysis was performed on the VAS assessments returned to the study site. | 24 Hours |
| Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge | Measurement of the amount of time to rescue medication in the postoperative period. | 24 hours |
| BG001 |
| IV Ketorolac |
Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | IV Ketorolac | Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds |
|
|
| Secondary | Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge | Measurement of the amount of rescue medication in the postoperative period. | Posted | Mean | Standard Deviation | milligrams | 24 hours |
|
|
|
| Secondary | Time to Discharge. | Measurement of the time to discharge in the postoperative period. | Posted | Mean | Standard Deviation | Hours | 24 hours |
|
|
|
| Secondary | Patient Satisfaction. | Measurement of patient satisfaction post-procedure. During the post-treatment period, subjects were asked to complete a satisfaction questionnaire (Quality of Recovery - 40 or QoR-40) defining their quality of recovery at 24 hours following surgery. The QoR - 40 is a 40-item questionnaire that provides a global score and subscores across five dimensions of quality of recovery: emotions (minimum score = 6, maximum score = 30), physical comfort (minimum score = 8, maximum score = 40), patient support (minimum score = 7, maximum score = 35), physical independence (minimum score = 5, maximum score = 25), and pain (minimum score = 7, maximum score = 35). Higher subscores represent a better outcome. Subscores are added to create a Global QoR-40 score. Global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
| Secondary | Incidence of Serious Adverse Events (SAEs). | Measurement of the incidence of serious adverse events. | Posted | Number | Number of Events | 24 hours |
|
|
|
| Secondary | Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours | Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) in the post-surgical period through 24 hours post-procedure. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject 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 and 100. Subject's were contacted at 24 hour post-discharge during a follow-up phone contact and asked to completed the VAS at Rest and VAS with Movement and return both completed VAS assessments via the envelope provided. The analysis was performed on the VAS assessments returned to the study site. | Posted | Mean | Standard Error | units on a scale | 24 Hours |
|
|
|
| Secondary | Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge | Measurement of the amount of time to rescue medication in the postoperative period. | Posted | Mean | Standard Deviation | Hours | 24 hours |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | IV Ketorolac | Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds | 0 | 31 | 0 | 31 |
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| D007213 |
| Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Patient Support |
|
| Physical Independence |
|
| Pain |
|