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Ketorolac is administered as current practice to the majority of patients undergoing knee arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.
Past studies have examined different doses of ketorolac administered to patients after spinal fusion surgery and found that 7.5 mg every 6 hours was as effective as 15 or 30 mg every 6 hours in decreasing postoperative pain and patient opiate consumption. Since ketorolac side effects such as gastrointestinal and surgical site bleeding seem to be dose related, utilizing a lower dose of ketorolac may be more efficacious.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 mg of Ketorolac | Placebo Comparator | participant receives 0 mg of Ketorolac |
|
| 7.5 mg of Ketorolac | Active Comparator | participant receives 7.5 mg of Ketorolac |
|
| 15 mg Ketorolac | Active Comparator | participant receives 15 mg of Ketorolac |
|
| 30 mg Ketorolac | Active Comparator | participant receives 30mg of Ketorolac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Dose | Drug | Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| PACU Opiate Consumption | Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME). | Less than 1 day (PACU stay in the postoperative period) |
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Population: Patients scheduled for outpatient knee arthroscopy under general anesthesia with ASA physical status I-III ages 18-65 years old. All subjects will receive informed consent. Subjects will not be eligible to participate if they cannot provide informed consent. Non-English speaking patients will not be included due to the limited time and availability of translators.
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia H Wilson, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29461 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0 mg of Ketorolac | participant receives 0 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| FG001 | 7.5 mg of Ketorolac | participant receives 7.5 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| FG002 | 15 mg Ketorolac | participant receives 15 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| FG003 | 30 mg Ketorolac | participant receives 30mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0 mg of Ketorolac | participant receives 0 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| 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 | PACU Opiate Consumption | Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME). | The study enrolled 112 patient with 28 patients randomized to each group. | Posted | Mean | Standard Error | IV Morphine Equivalents (mg) | Less than 1 day (PACU stay in the postoperative period) |
|
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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 | 0 mg of Ketorolac | participant receives 0 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator for Anesthesia and Perioperative Medicine | Medical University of South Carolina, Department of Anesthesia and Perioperative Medicine | 843-792-2322 | joneswr@musc.edu |
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| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
|
| BG001 | 7.5 mg of Ketorolac | participant receives 7.5 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| BG002 | 15 mg Ketorolac | participant receives 15 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| BG003 | 30 mg Ketorolac | participant receives 30mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
participant receives 7.5 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| OG002 | 15 mg Ketorolac | participant receives 15 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
| OG003 | 30 mg Ketorolac | participant receives 30mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | 7.5 mg of Ketorolac | participant receives 7.5 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). | 0 | 28 | 0 | 28 |
| EG002 | 15 mg Ketorolac | participant receives 15 mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). | 0 | 28 | 0 | 28 |
| EG003 | 30 mg Ketorolac | participant receives 30mg of Ketorolac Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg). | 0 | 28 | 0 | 28 |
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| D006571 | Heterocyclic Compounds |