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The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee and hip arthroplasty could be observed with the substitution of Intravenous meloxicam for ketorolac in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac group | Active Comparator | Participants will receive the institution specific joint replacement pain protocol, including ketorolac. |
|
| IV meloxicam group | Experimental | Participants will receive the institution specific joint replacement pain protocol, however with IV meloxicam substituted for ketorolac. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV meloxicam | Drug | Participants will be administered meloxicam 30 mg IV push pre-operatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measured by the Numeric Rating Scale | A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled from 0-10. | 2 hours postoperatively |
| Pain Measured by the Numeric Rating Scale | A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled 0-10. | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Score as Measured by a Likert Scale | Patients select a score to indicate the severity of their nausea. Scores of 0, 1-2, 3-6, and 7-9 indicate no nausea, mild nausea, moderate nausea, and severe nausea, respectively. The score 10 is assigned to vomiting. | 2 hours postoperatively |
| Nausea Score as Measured by a Likert Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor H Hernandez, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41167538 | Derived | Rizzo MG, Costello JP 2nd, Constantinescu DS, Samineni AV, Moore MR, Shittu AT, Tabibi O, Osman BM, Fiala RS, D'Apuzzo MR, Hernandez VH. Intravenous Meloxicam Versus Ketorolac for Pain Control Following Total Joint Arthroplasty: A Double-Blind Randomized Controlled Trial. J Arthroplasty. 2026 Jul;41(7):1954-1959. doi: 10.1016/j.arth.2025.10.052. Epub 2025 Oct 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac Group | Participants will receive the institution specific joint replacement pain protocol. Institution specific joint replacement pain protocol: Participants will be treated with a standard orthopaedic joint replacement protocol which includes:
Ketorolac: Participants will be treated with ketorolac 15 mg IV push intra-operatively, followed by 15 mg IV push every 6 hours scheduled for 2 doses. |
| FG001 | IV Meloxicam Group | Participants will be given IV meloxicam for pain management post total knee and hip arthroplasty. Institution specific joint replacement pain protocol: Participants will be treated with a standard orthopaedic joint replacement protocol which includes:
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac Group | Participants will receive the institution specific joint replacement pain protocol. Institution specific joint replacement pain protocol: Participants will be treated with a standard orthopaedic joint replacement protocol which includes:
Ketorolac: Participants will be treated with ketorolac 15 mg IV push intra-operatively, followed by 15 mg IV push every 6 hours scheduled for 2 doses. |
| 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 | Pain Measured by the Numeric Rating Scale | A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled from 0-10. | 15 patients in the ketorolac group and 24 in the Meloxicam group did not return survey data in the time period analyzed for this variable and were thus excluded. | Posted | Mean | Standard Deviation | units on a scale | 2 hours postoperatively |
|
6 weeks
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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 | Ketorolac Group | Participants will receive the institution specific joint replacement pain protocol. Institution specific joint replacement pain protocol: Participants will be treated with a standard orthopaedic joint replacement protocol which includes:
Ketorolac: Participants will be treated with ketorolac 15 mg IV push intra-operatively, followed by 15 mg IV push every 6 hours scheduled for 2 doses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Victor Hernandez | University of Miami Department of Orthopedics | (305) 689-5195 | vhh1@miami.edu |
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| 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 | Mar 30, 2022 | Jul 18, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Ketorolac | Drug | Participants will be treated with ketorolac 15 mg IV push intra-operatively, followed by 15 mg IV push every 6 hours scheduled for 2 doses. |
|
Patients select a score to indicate the severity of their nausea. Scores of 0, 1-2, 3-6, and 7-9 indicate no nausea, mild nausea, moderate nausea, and severe nausea, respectively. The score 10 is assigned to vomiting. |
| 24 hours postoperatively |
| Length of Stay as Measured by Hours in the Hospital | Length of stay for the patient as measured in hours from surgery until the moment of discharge | Until patient discharged from the hospital |
| Length of Stay as Measured by Hospital Nights | The total number of overnights spent in the hospital between surgery and discharge | From surgery until discharge |
| Length of Stay as Measured by Same Day Discharges | The number of patients which were able to be discharged home the same day as their surgical procedure | From surgery until discharge |
| Opioid Consumption as Measured by Morphine Milligram Equivalents (MME) | The amount of opioids a patient consumes converted into MME for standard comparisons | Within 2 hours postoperatively |
| Opioid Consumption as Measured by Morphine Milligram Equivalents (MME) | The amount of opioids a patient consumes converted into MME for standard comparisons | Within 24 hours postoperatively |
| Renal Injury as Measured by the Change in Creatinine Levels | The change in creatinine levels per patient as by comparing their standard preoperative lab creatinine values with the standard postoperative lab creatinine values before discharge from the hospital after their procedure, up to 1 week postoperatively. | From preoperative baseline labs while hospitalized, up to 1 week |
| BG001 | IV Meloxicam Group | Participants will be given IV meloxicam for pain management post total knee and hip arthroplasty. Institution specific joint replacement pain protocol: Participants will be treated with a standard orthopaedic joint replacement protocol which includes:
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively. |
| BG002 | 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 |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Laterality | Count of Participants | Participants |
|
| Procedure | Count of Participants | Participants |
|
| Apfel Score for Postoperative Nausea and Vomiting | Apfel scores range from 0 to 4, where the higher the score, the greater the predicted 24-h risk of PONV. | Mean | Standard Deviation | units on a scale |
|
| OG001 | IV Meloxicam Group | Participants will be given IV meloxicam for pain management post total knee and hip arthroplasty. Institution specific joint replacement pain protocol: Participants will be treated with a standard orthopaedic joint replacement protocol which includes:
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively. |
|
|
| Primary | Pain Measured by the Numeric Rating Scale | A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled 0-10. | 20 patients in the ketorolac group and 25 in the Meloxicam group did not return survey data in the time period analyzed for this variable and were thus excluded. | Posted | Mean | Standard Deviation | units on a scale | 24 hours postoperatively |
|
|
|
| Secondary | Nausea Score as Measured by a Likert Scale | Patients select a score to indicate the severity of their nausea. Scores of 0, 1-2, 3-6, and 7-9 indicate no nausea, mild nausea, moderate nausea, and severe nausea, respectively. The score 10 is assigned to vomiting. | 16 patients in the ketorolac group and 24 in the Meloxicam group did not return survey data in the time period analyzed for this variable and were thus excluded. | Posted | Mean | Standard Deviation | score on a scale | 2 hours postoperatively |
|
|
|
| Secondary | Nausea Score as Measured by a Likert Scale | Patients select a score to indicate the severity of their nausea. Scores of 0, 1-2, 3-6, and 7-9 indicate no nausea, mild nausea, moderate nausea, and severe nausea, respectively. The score 10 is assigned to vomiting. | 21 patients in the ketorolac group and 26 in the Meloxicam group did not return survey data in the time period analyzed for this variable and were thus excluded. | Posted | Mean | Standard Deviation | score on a scale | 24 hours postoperatively |
|
|
|
| Secondary | Length of Stay as Measured by Hours in the Hospital | Length of stay for the patient as measured in hours from surgery until the moment of discharge | Posted | Mean | Standard Deviation | hours | Until patient discharged from the hospital |
|
|
|
| Secondary | Length of Stay as Measured by Hospital Nights | The total number of overnights spent in the hospital between surgery and discharge | Posted | Mean | Standard Deviation | nights | From surgery until discharge |
|
|
|
| Secondary | Length of Stay as Measured by Same Day Discharges | The number of patients which were able to be discharged home the same day as their surgical procedure | Posted | Count of Participants | Participants | From surgery until discharge |
|
|
|
| Secondary | Opioid Consumption as Measured by Morphine Milligram Equivalents (MME) | The amount of opioids a patient consumes converted into MME for standard comparisons | Posted | Mean | Standard Deviation | morphine milligram equivalents | Within 2 hours postoperatively |
|
|
|
| Secondary | Opioid Consumption as Measured by Morphine Milligram Equivalents (MME) | The amount of opioids a patient consumes converted into MME for standard comparisons | Posted | Mean | Standard Deviation | morphine milligram equivalents | Within 24 hours postoperatively |
|
|
|
| Secondary | Renal Injury as Measured by the Change in Creatinine Levels | The change in creatinine levels per patient as by comparing their standard preoperative lab creatinine values with the standard postoperative lab creatinine values before discharge from the hospital after their procedure, up to 1 week postoperatively. | 28 patients in the ketorolac group and 24 in the Meloxicam group did not have available data in the time period analyzed for this variable and were thus excluded. Both Arm/Groups had the same reporting identical values. | Posted | Mean | Standard Deviation | mg/dL | From preoperative baseline labs while hospitalized, up to 1 week |
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| 0 |
| 114 |
| EG001 | IV Meloxicam Group | Participants will be given IV meloxicam for pain management post total knee and hip arthroplasty. Institution specific joint replacement pain protocol: Participants will be treated with a standard orthopaedic joint replacement protocol which includes:
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively. | 0 | 109 | 0 | 109 | 0 | 109 |
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Bilateral |
|