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CompletedNCT05291598Updated Aug 14, 2024Results posted

Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

A Phase 3 interventional study of IV meloxicam and Ketorolac in Total Knee Replacement and Total Hip Replacement, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by University of Miami · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
223
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Total Knee Replacement
  • Total Hip Replacement
03

In context

Lead sponsor

University of Miami is the lead sponsor of 838 studies on the registry; 164 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 96 (84%) have results posted.

Browse University of Miami studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients over the age of 18,
  2. Patients undergoing primary total knee or primary total hip replacement at the University of Miami Hospital,
  3. Patients that have capacity to provide medical consent

Exclusion criteria

Exclusion Criteria:

  1. All patients under the age of 18
  2. Prisoners, diabetics, increased risk of bleeding, and pregnant women.
  3. Patients with prior surgery or history of infection on the joint of interest.
  4. Patients with an estimated glomerular filtration rate (eGFR) \<50 ml/min
  5. Patients on dialysis or renal transplant.
  6. Patients on steroid preoperatively.
  7. Allergy to sulfas
  8. Inability to provide medical consent.
  9. Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
223 participants (actual)

Study arms

  • Active comparator
    Ketorolac group

    Participants will receive the institution specific joint replacement pain protocol, including ketorolac.

    Drug: Ketorolac

  • Experimental
    IV meloxicam group

    Participants will receive the institution specific joint replacement pain protocol, however with IV meloxicam substituted for ketorolac.

    Drug: IV meloxicam

Interventions

  • DrugIV meloxicam

    Participants will be administered meloxicam 30 mg IV push pre-operatively.

  • DrugKetorolac

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 hours postoperatively

  2. 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.

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. 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.

    Time frame: 2 hours postoperatively

  2. 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.

    Time frame: 24 hours postoperatively

  3. 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

    Time frame: Until patient discharged from the hospital

  4. Length of Stay as Measured by Hospital Nights

    The total number of overnights spent in the hospital between surgery and discharge

    Time frame: From surgery until discharge

  5. 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

    Time frame: From surgery until discharge

  6. Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)

    The amount of opioids a patient consumes converted into MME for standard comparisons

    Time frame: Within 2 hours postoperatively

  7. Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)

    The amount of opioids a patient consumes converted into MME for standard comparisons

    Time frame: Within 24 hours postoperatively

  8. 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.

    Time frame: From preoperative baseline labs while hospitalized, up to 1 week

07

Results

Posted Aug 14, 2024

Participant flow

Participant flow — Overall Study
MilestoneKetorolac GroupIV Meloxicam Group
Started114109
Completed114109
Not completed00

Outcome measures

PrimaryPain 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.

Time frame:
2 hours postoperatively
Reported as:
Mean · units on a scale
Pain Measured by the Numeric Rating Scale
units on a scaleKetorolac GroupIV Meloxicam Group
Pain Measured by the Numeric Rating Scale3.34 ± 3.253.32 ± 3.39
PrimaryPain 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.

Time frame:
24 hours postoperatively
Reported as:
Mean · units on a scale
Pain Measured by the Numeric Rating Scale
units on a scaleKetorolac GroupIV Meloxicam Group
Pain Measured by the Numeric Rating Scale4.06 ± 3.073.75 ± 3.19
SecondaryNausea 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.

Time frame:
2 hours postoperatively
Reported as:
Mean · score on a scale
Nausea Score as Measured by a Likert Scale
score on a scaleKetorolac GroupIV Meloxicam Group
Nausea Score as Measured by a Likert Scale0.42 ± 1.620.54 ± 1.80
SecondaryNausea 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.

Time frame:
24 hours postoperatively
Reported as:
Mean · score on a scale
Nausea Score as Measured by a Likert Scale
score on a scaleKetorolac GroupIV Meloxicam Group
Nausea Score as Measured by a Likert Scale0.48 ± 1.530.29 ± 0.96
SecondaryLength 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

Time frame:
Until patient discharged from the hospital
Reported as:
Mean · hours
Length of Stay as Measured by Hours in the Hospital
hoursKetorolac GroupIV Meloxicam Group
Length of Stay as Measured by Hours in the Hospital37.87 ± 49.8141.56 ± 34.30
SecondaryLength of Stay as Measured by Hospital Nights

The total number of overnights spent in the hospital between surgery and discharge

Time frame:
From surgery until discharge
Reported as:
Mean · nights
Length of Stay as Measured by Hospital Nights
nightsKetorolac GroupIV Meloxicam Group
Length of Stay as Measured by Hospital Nights1.51 ± 2.071.63 ± 1.40
SecondaryLength 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

Time frame:
From surgery until discharge
Reported as:
Count of participants · Participants
Length of Stay as Measured by Same Day Discharges
ParticipantsKetorolac GroupIV Meloxicam Group
Length of Stay as Measured by Same Day Discharges2310
SecondaryOpioid Consumption as Measured by Morphine Milligram Equivalents (MME)

The amount of opioids a patient consumes converted into MME for standard comparisons

Time frame:
Within 2 hours postoperatively
Reported as:
Mean · morphine milligram equivalents
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
morphine milligram equivalentsKetorolac GroupIV Meloxicam Group
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)1.98 ± 4.842.00 ± 3.09
SecondaryOpioid Consumption as Measured by Morphine Milligram Equivalents (MME)

The amount of opioids a patient consumes converted into MME for standard comparisons

Time frame:
Within 24 hours postoperatively
Reported as:
Mean · morphine milligram equivalents
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
morphine milligram equivalentsKetorolac GroupIV Meloxicam Group
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)20.59 ± 26.4628.21 ± 24.22
SecondaryRenal 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.

Time frame:
From preoperative baseline labs while hospitalized, up to 1 week
Reported as:
Mean · mg/dL
Renal Injury as Measured by the Change in Creatinine Levels
mg/dLKetorolac GroupIV Meloxicam Group
Renal Injury as Measured by the Change in Creatinine Levels0.09 ± 0.190.09 ± 0.19

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ketorolac Group0/114 (0%)0/114 (0%)0/114 (0%)
IV Meloxicam Group0/109 (0%)0/109 (0%)0/109 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Ketorolac GroupIV Meloxicam GroupTotal
Mean64.65 ± 9.5664.34 ± 8.9364.50 ± 9.24
Sex: Female, Male
Sex: Female, Male(Participants)Ketorolac GroupIV Meloxicam GroupTotal
Female6260122
Male5249101
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Ketorolac GroupIV Meloxicam GroupTotal
Count of participants——0
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Ketorolac GroupIV Meloxicam GroupTotal
Mean30.73 ± 5.4931.10 ± 5.9130.91 ± 5.69
Laterality
Laterality(Participants)Ketorolac GroupIV Meloxicam GroupTotal
Right5758115
Left5651107
Bilateral101
Procedure
Procedure(Participants)Ketorolac GroupIV Meloxicam GroupTotal
Total Hip Arthroplasty454489
Total Knee Arthroplasty6965134
Apfel Score for Postoperative Nausea and Vomiting
Apfel Score for Postoperative Nausea and Vomiting(units on a scale)Ketorolac GroupIV Meloxicam GroupTotal
Mean1.78 ± 0.902.00 ± 0.891.88 ± 0.90
08

Study locations

1 site
  • University of Miami
    Miami, Florida 33136, United States
09

References and documents

Publications

  • 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. PubMed 41167538 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 30, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05291598
Lead sponsor
University of Miami
Responsible party
Victor Hugo Hernandez (Professor Chief - Division of Arthroplasty & Adult Reconstruction, Department of Orthopaedics, University of Miami) — Principal investigator
First posted
Mar 22, 2022
Start date
May 1, 2022
Primary completion
May 1, 2023
Completion
May 1, 2023
Results posted
Aug 14, 2024
Last update
Aug 14, 2024

Study contacts

Victor H Hernandez, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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