Femur Fracture, Tibial Fractures
Conditions
Keywords
Opioid use, Post-operative pain, Analgesic use, Femur fracture, Tibia fracture, Intramedullary Nailing
Brief summary
The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. This study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.
Detailed description
The data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. Therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (Group 1 vs. Group 2). Likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (Group 3 vs. Group 4).
Interventions
DRUGIntravenous ketorolac and oral acetaminophen
ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group
DRUGIntravenous morphine and oral oxycodone
Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.
Sponsors
University of Puerto Rico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients with tibial and femoral shaft fractures 2. Patients undergoing intramedullary nailing 3. Willing to participate in the protocol
Exclusion criteria
1. Chronic pain disorder (daily use of oral opioids) 2. Allergy or hypersensitivity to non steroid anti-inflammatory drug 3. Impaired renal, cardiac, or hepatic function 4. History of gastrointestinal bleeding or substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 48hrs MME | Measured at postoperative hour 48 | Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME) |
| 12hrs VAS Pain Scores | Measured at postoperative hour 12 | Visual Analog Scale; 0-10 (10 indicates highest degree of pain) |
| 24hrs VAS Pain Score | Measured at postoperative hour 24 | Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain) |
| 36hrs VAS Pain Scores | Measured at postoperative hour 36 | Visual Analog Scale; 0-10 (10 indicates highest degree of pain) |
| 48hrs VAS Pain Scores | Measured at postoperative hour 48 | Visual Analog Scale; 0-10 (10 indicates highest degree of pain) |
| 12hrs MME | Measured at postoperative hour 12 | Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME) |
| 24hrs MME | Measured at postoperative hour 24 | Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME) |
| 36hrs MME | Measured at postoperative hour 36 | Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | Determined by discharge date | Time from intervention to discharge |
Countries
Puerto Rico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so. | 52 |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. | 44 |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so. | 29 |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone Group 4 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours. | 42 |
| Total | 167 |
Baseline characteristics
| Characteristic | Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | Total | Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen |
|---|---|---|---|---|---|
| Age, Continuous | 40 Years | 36 Years | 31 Years | 40 Years | 31 Years |
| Body Mass Index (BMI) | 26.7 Kg/m^2 STANDARD_DEVIATION 6.2 | 26.8 Kg/m^2 STANDARD_DEVIATION 6.3 | 27.1 Kg/m^2 STANDARD_DEVIATION 7.1 | 26.9 Kg/m^2 STANDARD_DEVIATION 6.21 | 26.6 Kg/m^2 STANDARD_DEVIATION 5.9 |
| Diabetes Status No | 34 Participants | 146 Participants | 26 Participants | 39 Participants | 47 Participants |
| Diabetes Status Yes | 8 Participants | 21 Participants | 3 Participants | 5 Participants | 5 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — | — |
| Sex: Female, Male Female | 13 Participants | 36 Participants | 6 Participants | 10 Participants | 7 Participants |
| Sex: Female, Male Male | 29 Participants | 131 Participants | 23 Participants | 34 Participants | 45 Participants |
| Smoker status Non-smoker | 29 Participants | 123 Participants | 23 Participants | 32 Participants | 39 Participants |
| Smoker status Smoker | 13 Participants | 44 Participants | 6 Participants | 12 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 46 | 0 / 29 | 0 / 42 |
| other Total, other adverse events | 0 / 52 | 0 / 46 | 0 / 29 | 0 / 42 |
| serious Total, serious adverse events | 2 / 52 | 3 / 46 | 7 / 29 | 8 / 42 |
Outcome results
Primary
12hrs MME
Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)
Time frame: Measured at postoperative hour 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 12hrs MME | 2.9 Morphine Milligram Equivalents (MME) | Standard Deviation 7.5 |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 12hrs MME | 8.5 Morphine Milligram Equivalents (MME) | Standard Deviation 10.1 |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 12hrs MME | 2.9 Morphine Milligram Equivalents (MME) | Standard Deviation 4.5 |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 12hrs MME | 12.1 Morphine Milligram Equivalents (MME) | Standard Deviation 11.6 |
p-value: 0.002t-test, 2 sided
p-value: <0.001t-test, 2 sided
Primary
12hrs VAS Pain Scores
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
Time frame: Measured at postoperative hour 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 12hrs VAS Pain Scores | 7.6 score on a scale | Standard Deviation 2.2 |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 12hrs VAS Pain Scores | 7.9 score on a scale | Standard Deviation 2.01 |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 12hrs VAS Pain Scores | 7.3 score on a scale | Standard Deviation 2.5 |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 12hrs VAS Pain Scores | 7.2 score on a scale | Standard Deviation 2 |
p-value: 0.215t-test, 2 sided
p-value: 0.445t-test, 2 sided
Primary
24hrs MME
Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)
Time frame: Measured at postoperative hour 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 24hrs MME | 9.2 Morphine Milligram Equivalents (MME) | Standard Deviation 18.6 |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 24hrs MME | 21.49 Morphine Milligram Equivalents (MME) | Standard Deviation 22.4 |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 24hrs MME | 10.4 Morphine Milligram Equivalents (MME) | Standard Deviation 13.6 |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 24hrs MME | 28.8 Morphine Milligram Equivalents (MME) | Standard Deviation 20.6 |
p-value: 0.002t-test, 2 sided
p-value: <0.001t-test, 2 sided
Primary
24hrs VAS Pain Score
Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)
Time frame: Measured at postoperative hour 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 24hrs VAS Pain Score | 4.9 score on a scale | Standard Deviation 2.5 |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 24hrs VAS Pain Score | 5.9 score on a scale | Standard Deviation 2.6 |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 24hrs VAS Pain Score | 5.4 score on a scale | Standard Deviation 2.6 |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 24hrs VAS Pain Score | 5.1 score on a scale | Standard Deviation 2.4 |
p-value: 0.041t-test, 2 sided
p-value: 0.3t-test, 2 sided
Primary
36hrs MME
Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)
Time frame: Measured at postoperative hour 36
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 36hrs MME | 14.1 Morphine Milligram Equivalents (MME) | Standard Deviation 25.9 |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 36hrs MME | 29.5 Morphine Milligram Equivalents (MME) | Standard Deviation 29.9 |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 36hrs MME | 15.7 Morphine Milligram Equivalents (MME) | Standard Deviation 15.9 |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 36hrs MME | 36.6 Morphine Milligram Equivalents (MME) | Standard Deviation 29.1 |
p-value: 0.004t-test, 2 sided
p-value: <0.001t-test, 2 sided
Primary
36hrs VAS Pain Scores
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
Time frame: Measured at postoperative hour 36
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 36hrs VAS Pain Scores | 4.9 score on a scale | Standard Deviation 2.5 |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 36hrs VAS Pain Scores | 5.63 score on a scale | Standard Deviation 2.3 |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 36hrs VAS Pain Scores | 5.3 score on a scale | Standard Deviation 1.8 |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 36hrs VAS Pain Scores | 5.6 score on a scale | Standard Deviation 2.3 |
p-value: 0.12t-test, 2 sided
p-value: 0.359t-test, 2 sided
Primary
48hrs MME
Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)
Time frame: Measured at postoperative hour 48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 48hrs MME | 18.3 Morphine Milligram Equivalents (MME) | Standard Deviation 33.3 |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 48hrs MME | 37.2 Morphine Milligram Equivalents (MME) | Standard Deviation 37.8 |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 48hrs MME | 20.1 Morphine Milligram Equivalents (MME) | Standard Deviation 21 |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 48hrs MME | 48.0 Morphine Milligram Equivalents (MME) | Standard Deviation 35.6 |
p-value: 0.006t-test, 2 sided
p-value: <0.001t-test, 2 sided
Primary
48hrs VAS Pain Scores
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
Time frame: Measured at postoperative hour 48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 48hrs VAS Pain Scores | 3.6 score on a scale | Standard Deviation 2.01 |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 48hrs VAS Pain Scores | 4.3 score on a scale | Standard Deviation 2.6 |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | 48hrs VAS Pain Scores | 4.0 score on a scale | Standard Deviation 1.6 |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | 48hrs VAS Pain Scores | 3.4 score on a scale | Standard Deviation 2.2 |
p-value: 0.083t-test, 2 sided
p-value: 0.152t-test, 2 sided
Secondary
Hospital Length of Stay
Time from intervention to discharge
Time frame: Determined by discharge date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | Hospital Length of Stay | 1.9 Days | Standard Deviation 0.61 |
| Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | Hospital Length of Stay | 2.00 Days | Standard Deviation 0.89 |
| Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | Hospital Length of Stay | 1.8 Days | Standard Deviation 0.5 |
| Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone | Hospital Length of Stay | 1.9 Days | Standard Deviation 1.1 |
p-value: 0.354t-test, 2 sided
p-value: 0.455t-test, 2 sided