Trial Outcomes & Findings for Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures (NCT NCT04761302)
NCT ID: NCT04761302
Last Updated: 2025-03-04
Results Overview
Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
167 participants
Primary outcome timeframe
Measured at postoperative hour 12
Results posted on
2025-03-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
Group 4 will be composed of femoral 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
44
|
29
|
42
|
|
Overall Study
COMPLETED
|
52
|
44
|
29
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
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 |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 Participants
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.
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=44 Participants
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.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 Participants
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 Participants
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.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31 Years
n=52 Participants
|
40 Years
n=44 Participants
|
31 Years
n=29 Participants
|
40 Years
n=42 Participants
|
36 Years
n=167 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=52 Participants
|
10 Participants
n=44 Participants
|
6 Participants
n=29 Participants
|
13 Participants
n=42 Participants
|
36 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=52 Participants
|
34 Participants
n=44 Participants
|
23 Participants
n=29 Participants
|
29 Participants
n=42 Participants
|
131 Participants
n=167 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
26.6 Kg/m^2
STANDARD_DEVIATION 5.90 • n=52 Participants
|
26.9 Kg/m^2
STANDARD_DEVIATION 6.21 • n=44 Participants
|
27.1 Kg/m^2
STANDARD_DEVIATION 7.1 • n=29 Participants
|
26.7 Kg/m^2
STANDARD_DEVIATION 6.2 • n=42 Participants
|
26.8 Kg/m^2
STANDARD_DEVIATION 6.3 • n=167 Participants
|
|
Smoker status
Smoker
|
13 Participants
n=52 Participants
|
12 Participants
n=44 Participants
|
6 Participants
n=29 Participants
|
13 Participants
n=42 Participants
|
44 Participants
n=167 Participants
|
|
Smoker status
Non-smoker
|
39 Participants
n=52 Participants
|
32 Participants
n=44 Participants
|
23 Participants
n=29 Participants
|
29 Participants
n=42 Participants
|
123 Participants
n=167 Participants
|
|
Diabetes Status
Yes
|
5 Participants
n=52 Participants
|
5 Participants
n=44 Participants
|
3 Participants
n=29 Participants
|
8 Participants
n=42 Participants
|
21 Participants
n=167 Participants
|
|
Diabetes Status
No
|
47 Participants
n=52 Participants
|
39 Participants
n=44 Participants
|
26 Participants
n=29 Participants
|
34 Participants
n=42 Participants
|
146 Participants
n=167 Participants
|
PRIMARY outcome
Timeframe: Measured at postoperative hour 12Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
Outcome measures
| Measure |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 Participants
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.
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=44 Participants
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.
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 Participants
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 Participants
Group 4 will be composed of femoral 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.
|
|---|---|---|---|---|
|
12hrs VAS Pain Scores
|
7.6 score on a scale
Standard Deviation 2.20
|
7.9 score on a scale
Standard Deviation 2.01
|
7.3 score on a scale
Standard Deviation 2.5
|
7.2 score on a scale
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: Measured at postoperative hour 24Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)
Outcome measures
| Measure |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 Participants
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.
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=44 Participants
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.
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 Participants
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 Participants
Group 4 will be composed of femoral 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.
|
|---|---|---|---|---|
|
24hrs VAS Pain Score
|
4.9 score on a scale
Standard Deviation 2.5
|
5.9 score on a scale
Standard Deviation 2.6
|
5.4 score on a scale
Standard Deviation 2.6
|
5.1 score on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Measured at postoperative hour 36Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
Outcome measures
| Measure |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 Participants
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.
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=44 Participants
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.
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 Participants
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 Participants
Group 4 will be composed of femoral 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.
|
|---|---|---|---|---|
|
36hrs VAS Pain Scores
|
4.9 score on a scale
Standard Deviation 2.5
|
5.63 score on a scale
Standard Deviation 2.3
|
5.3 score on a scale
Standard Deviation 1.8
|
5.6 score on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Measured at postoperative hour 48Visual Analog Scale; 0-10 (10 indicates highest degree of pain)
Outcome measures
| Measure |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 Participants
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.
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=44 Participants
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.
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 Participants
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 Participants
Group 4 will be composed of femoral 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.
|
|---|---|---|---|---|
|
48hrs VAS Pain Scores
|
3.6 score on a scale
Standard Deviation 2.01
|
4.3 score on a scale
Standard Deviation 2.6
|
4.0 score on a scale
Standard Deviation 1.6
|
3.4 score on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Measured at postoperative hour 12Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)
Outcome measures
| Measure |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 Participants
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.
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=44 Participants
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.
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 Participants
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 Participants
Group 4 will be composed of femoral 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.
|
|---|---|---|---|---|
|
12hrs MME
|
2.9 Morphine Milligram Equivalents (MME)
Standard Deviation 7.5
|
8.5 Morphine Milligram Equivalents (MME)
Standard Deviation 10.1
|
2.9 Morphine Milligram Equivalents (MME)
Standard Deviation 4.5
|
12.1 Morphine Milligram Equivalents (MME)
Standard Deviation 11.6
|
PRIMARY outcome
Timeframe: Measured at postoperative hour 24Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)
Outcome measures
| Measure |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 Participants
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.
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=44 Participants
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.
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 Participants
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 Participants
Group 4 will be composed of femoral 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.
|
|---|---|---|---|---|
|
24hrs MME
|
9.2 Morphine Milligram Equivalents (MME)
Standard Deviation 18.6
|
21.49 Morphine Milligram Equivalents (MME)
Standard Deviation 22.4
|
10.4 Morphine Milligram Equivalents (MME)
Standard Deviation 13.6
|
28.8 Morphine Milligram Equivalents (MME)
Standard Deviation 20.6
|
PRIMARY outcome
Timeframe: Measured at postoperative hour 36Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)
Outcome measures
| Measure |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 Participants
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.
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=44 Participants
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.
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 Participants
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 Participants
Group 4 will be composed of femoral 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.
|
|---|---|---|---|---|
|
36hrs MME
|
14.1 Morphine Milligram Equivalents (MME)
Standard Deviation 25.9
|
29.5 Morphine Milligram Equivalents (MME)
Standard Deviation 29.9
|
15.7 Morphine Milligram Equivalents (MME)
Standard Deviation 15.9
|
36.6 Morphine Milligram Equivalents (MME)
Standard Deviation 29.1
|
PRIMARY outcome
Timeframe: Measured at postoperative hour 48Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)
Outcome measures
| Measure |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 Participants
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.
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=44 Participants
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.
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 Participants
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 Participants
Group 4 will be composed of femoral 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.
|
|---|---|---|---|---|
|
48hrs MME
|
18.3 Morphine Milligram Equivalents (MME)
Standard Deviation 33.3
|
37.2 Morphine Milligram Equivalents (MME)
Standard Deviation 37.8
|
20.1 Morphine Milligram Equivalents (MME)
Standard Deviation 21.0
|
48.0 Morphine Milligram Equivalents (MME)
Standard Deviation 35.6
|
SECONDARY outcome
Timeframe: Determined by discharge dateTime from intervention to discharge
Outcome measures
| Measure |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 Participants
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.
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=44 Participants
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.
Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 Participants
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.
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 Participants
Group 4 will be composed of femoral 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.
|
|---|---|---|---|---|
|
Hospital Length of Stay
|
1.9 Days
Standard Deviation 0.61
|
2.00 Days
Standard Deviation 0.89
|
1.8 Days
Standard Deviation 0.5
|
1.9 Days
Standard Deviation 1.1
|
Adverse Events
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=52 participants at risk
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.
Intravenous 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
|
Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=46 participants at risk
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.
Intravenous 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.
|
Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen
n=29 participants at risk
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.
Intravenous 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
|
Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone
n=42 participants at risk
Group 4 will be composed of femoral 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.
Intravenous 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.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Non-Union
|
3.8%
2/52 • 9 months
|
6.5%
3/46 • 9 months
|
6.9%
2/29 • 9 months
|
4.8%
2/42 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Delayed Union
|
0.00%
0/52 • 9 months
|
0.00%
0/46 • 9 months
|
17.2%
5/29 • 9 months
|
14.3%
6/42 • 9 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hans Hess
University of Puerto Rico: Department of Orthopedic Surgery
Phone: 787-365-5755
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place