| Primary | 12hrs VAS Pain Scores | Visual Analog Scale; 0-10 (10 indicates highest degree of pain) | | Posted | | Mean | Standard Deviation | score on a scale | | Measured at postoperative hour 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. 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. | | OG002 | 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. | | OG003 | 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. |
| | Units | Counts |
|---|
| Participants | - OG00052
- OG00144
- OG00229
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0007.6± 2.20
- OG0017.9± 2.01
- OG0027.3± 2.5
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | | 0.215 | A priori threshold for statistical significance: <0.05 | | | | | | | | | | | | | Superiority | | | | | t-test, 2 sided | | 0.445 |
|
| Primary | 24hrs VAS Pain Score | Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain) | | Posted | | Mean | Standard Deviation | score on a scale | | Measured at postoperative hour 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. 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 | | OG001 | 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. 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. |
|
| Primary | 36hrs VAS Pain Scores | Visual Analog Scale; 0-10 (10 indicates highest degree of pain) | | Posted | | Mean | Standard Deviation | score on a scale | | Measured at postoperative hour 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. 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. |
|
| Primary | 48hrs VAS Pain Scores | Visual Analog Scale; 0-10 (10 indicates highest degree of pain) | | Posted | | Mean | Standard Deviation | score on a scale | | Measured at postoperative hour 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. 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. |
|
| Primary | 12hrs MME | Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME) | | Posted | | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | | Measured at postoperative hour 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | |
|
| Primary | 24hrs MME | Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME) | | Posted | | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | | Measured at postoperative hour 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | |
|
| Primary | 36hrs MME | Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME) | | Posted | | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | | Measured at postoperative hour 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | |
|
| Primary | 48hrs MME | Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME) | | Posted | | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | | Measured at postoperative hour 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen | |
|
| Secondary | Hospital Length of Stay | Time from intervention to discharge | | Posted | | Mean | Standard Deviation | Days | | Determined by discharge date | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. 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. |
|