Trial Outcomes & Findings for Meloxicam for Pain Management After Total Joint Arthroplasty (TJA) (NCT NCT05291598)
NCT ID: NCT05291598
Last Updated: 2024-08-14
Results Overview
A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled from 0-10.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
223 participants
Primary outcome timeframe
2 hours postoperatively
Results posted on
2024-08-14
Participant Flow
Participant milestones
| Measure |
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
109
|
|
Overall Study
COMPLETED
|
114
|
109
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ketorolac Group
n=114 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=109 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.65 years
STANDARD_DEVIATION 9.56 • n=114 Participants
|
64.34 years
STANDARD_DEVIATION 8.93 • n=109 Participants
|
64.50 years
STANDARD_DEVIATION 9.24 • n=223 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=114 Participants
|
60 Participants
n=109 Participants
|
122 Participants
n=223 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=114 Participants
|
49 Participants
n=109 Participants
|
101 Participants
n=223 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
30.73 kg/m^2
STANDARD_DEVIATION 5.49 • n=114 Participants
|
31.10 kg/m^2
STANDARD_DEVIATION 5.91 • n=109 Participants
|
30.91 kg/m^2
STANDARD_DEVIATION 5.69 • n=223 Participants
|
|
Laterality
Right
|
57 Participants
n=114 Participants
|
58 Participants
n=109 Participants
|
115 Participants
n=223 Participants
|
|
Laterality
Left
|
56 Participants
n=114 Participants
|
51 Participants
n=109 Participants
|
107 Participants
n=223 Participants
|
|
Laterality
Bilateral
|
1 Participants
n=114 Participants
|
0 Participants
n=109 Participants
|
1 Participants
n=223 Participants
|
|
Procedure
Total Hip Arthroplasty
|
45 Participants
n=114 Participants
|
44 Participants
n=109 Participants
|
89 Participants
n=223 Participants
|
|
Procedure
Total Knee Arthroplasty
|
69 Participants
n=114 Participants
|
65 Participants
n=109 Participants
|
134 Participants
n=223 Participants
|
|
Apfel Score for Postoperative Nausea and Vomiting
|
1.78 units on a scale
STANDARD_DEVIATION 0.90 • n=114 Participants
|
2.00 units on a scale
STANDARD_DEVIATION 0.89 • n=109 Participants
|
1.88 units on a scale
STANDARD_DEVIATION 0.90 • n=223 Participants
|
PRIMARY outcome
Timeframe: 2 hours postoperativelyPopulation: 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.
A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled from 0-10.
Outcome measures
| Measure |
Ketorolac Group
n=99 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=85 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Pain Measured by the Numeric Rating Scale
|
3.34 units on a scale
Standard Deviation 3.25
|
3.32 units on a scale
Standard Deviation 3.39
|
PRIMARY outcome
Timeframe: 24 hours postoperativelyPopulation: 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.
A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled 0-10.
Outcome measures
| Measure |
Ketorolac Group
n=94 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=84 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Pain Measured by the Numeric Rating Scale
|
4.06 units on a scale
Standard Deviation 3.07
|
3.75 units on a scale
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: 2 hours postoperativelyPopulation: 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.
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.
Outcome measures
| Measure |
Ketorolac Group
n=98 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=85 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Nausea Score as Measured by a Likert Scale
|
0.42 score on a scale
Standard Deviation 1.62
|
0.54 score on a scale
Standard Deviation 1.80
|
SECONDARY outcome
Timeframe: 24 hours postoperativelyPopulation: 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.
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.
Outcome measures
| Measure |
Ketorolac Group
n=93 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=83 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Nausea Score as Measured by a Likert Scale
|
0.48 score on a scale
Standard Deviation 1.53
|
0.29 score on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Until patient discharged from the hospitalLength of stay for the patient as measured in hours from surgery until the moment of discharge
Outcome measures
| Measure |
Ketorolac Group
n=114 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=109 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Length of Stay as Measured by Hours in the Hospital
|
37.87 hours
Standard Deviation 49.81
|
41.56 hours
Standard Deviation 34.30
|
SECONDARY outcome
Timeframe: From surgery until dischargeThe total number of overnights spent in the hospital between surgery and discharge
Outcome measures
| Measure |
Ketorolac Group
n=114 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=109 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Length of Stay as Measured by Hospital Nights
|
1.51 nights
Standard Deviation 2.07
|
1.63 nights
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: From surgery until dischargeThe number of patients which were able to be discharged home the same day as their surgical procedure
Outcome measures
| Measure |
Ketorolac Group
n=114 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=109 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Length of Stay as Measured by Same Day Discharges
|
23 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Within 2 hours postoperativelyThe amount of opioids a patient consumes converted into MME for standard comparisons
Outcome measures
| Measure |
Ketorolac Group
n=114 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=109 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
|
1.98 morphine milligram equivalents
Standard Deviation 4.84
|
2.00 morphine milligram equivalents
Standard Deviation 3.09
|
SECONDARY outcome
Timeframe: Within 24 hours postoperativelyThe amount of opioids a patient consumes converted into MME for standard comparisons
Outcome measures
| Measure |
Ketorolac Group
n=114 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=109 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
|
20.59 morphine milligram equivalents
Standard Deviation 26.46
|
28.21 morphine milligram equivalents
Standard Deviation 24.22
|
SECONDARY outcome
Timeframe: From preoperative baseline labs while hospitalized, up to 1 weekPopulation: 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.
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.
Outcome measures
| Measure |
Ketorolac Group
n=86 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
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.
|
IV Meloxicam Group
n=85 Participants
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:
* Dexamethasone
* Tylenol
* Lyrica
* Celebrex
* Meloxicam
* Oxycodone
IV meloxicam: Participants will be administered meloxicam 30 mg IV push pre-operatively.
|
|---|---|---|
|
Renal Injury as Measured by the Change in Creatinine Levels
|
0.09 mg/dL
Standard Deviation 0.19
|
0.09 mg/dL
Standard Deviation 0.19
|
Adverse Events
Ketorolac Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Meloxicam Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Victor Hernandez
University of Miami Department of Orthopedics
Phone: (305) 689-5195
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place