Nonspecific Pain Post Traumatic Injury
Conditions
Brief summary
This is a comparative effectiveness study of current pain management strategies in acutely injured trauma patients. Two different multi-modal, opioid minimizing analgesic strategies will be compared \[original multimodal pain regimen (MMPR) compared to multi-modal analgesic strategies for trauma (MAST) MMPR\].
Interventions
DRUGAcetaminophen IV/PO
Acetaminophen 1g IV/PO every 6 hours
DRUGAcetaminophen PO
Acetaminophen 1g PO every 6 hours
DRUGKetorolac
Ketorolac 30mg IV once
DRUGCelebrex
Celebrex 200mg PO every 12 hours
DRUGNaproxen
Naproxen 500mg PO every 12 hours
DRUGTramadol
Tramadol 100mg PO every 6 hours
DRUGPregabalin
Pregabalin 100mg PO every 8 hours
DRUGGabapentin
Gabapentin 300mg PO every 8 hours
DRUGLidocaine
Lidocaine patch every 12 hours
DRUGOpioids
Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)
DRUGRegional anesthesia
Regional anesthesia
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients admitted to the trauma service who are 16 years and older.
Exclusion criteria
* pregnant * prisoner * patients placed in observation (i.e. not admitted to the hospital)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use Per Day | until discharge from hospital or 30 days post admission (whichever is sooner) | Opioid use per day is calculated by tallying the dose equivalency of all opioids received and dividing by the number of days hospitalized. Morphine milligram equivalents (MME) per day are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Assessed by Score on the Behavioral Pain Scale (BPS) | until discharge from hospital or 30 days post admission (whichever is sooner) | An average will be calculated of the daily score on the Behavioral Pain Scale (BPS). BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants. |
| Number of Participants Discharged From the Hospital With an Opioid Prescription | Up to 30 days | — |
| Number of Participants With Any Opioid-related Complications | until discharge from hospital or 30 days post admission (whichever is sooner) | Opioid-related complications include ileus, aspiration, unplanned intubation, unplanned admission to an intensive care unit, and use of an opioid-reversal agent. |
| Overall Costs | until discharge from hospital or 30 days post admission (whichever is sooner) | the costs associated with the overall hospitalization or the first 30 days (whichever is sooner) related to post trauma care and complications incurred. |
| Pharmacy Costs | until discharge from hospital or 30 days post admission (whichever is sooner) | The costs of the pain medications given during the specified time period. |
| Pain as Assessed by Score on the Numeric Rating Scale (NRS) | until discharge from hospital or 30 days post admission (whichever is sooner) | An average will be calculated of the daily numeric rating scale (NRS) for pain (0=no pain, 10=worst pain). This assessment is used in verbal participants. |
| Number of Hospital Days | 30 days | The number of days the patient was hospitalized post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval. |
| Number of Intensive Care Unti (ICU) Days | 30 days | The number of days the patient was in the ICU post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval. |
| Degree to Which Function is Limited by Pain as Assessed by Percent of Predicted Daily Incentive Spirometry Volumes (Which is Based on Ideal Body Weight) | until discharge from hospital or 30 days post admission (whichever is sooner) | Clinical based pain scores ranging from 0 to 10 will be assessed at regular intervals throughout the hospitalization. |
| Degree to Which Function is Limited by Pain as Indicated by Number of Participants Who Failed to Work With Physical Therapist Due to Pain | until discharge from hospital or 30 days post admission (whichever is sooner) | — |
| Number of Ventilator Days | 30 days | The number of days the patient on a ventilator post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Original MMPR - Descending Dose Arm Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter. | 787 |
| MAST MMPR - Escalating Dose Arm Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter. | 774 |
| Total | 1,561 |
Baseline characteristics
| Characteristic | MAST MMPR - Escalating Dose Arm | Total | Original MMPR - Descending Dose Arm |
|---|---|---|---|
| Age, Continuous | 45 years | 45 years | 44 years |
| Injury Severity Score (ISS) | 14 units on a scale | 14 units on a scale | 14 units on a scale |
| Number of participants who underwent amputation procedure | 12 Participants | 21 Participants | 9 Participants |
| Number of participants who underwent laparotomy procedure | 86 Participants | 182 Participants | 96 Participants |
| Number of participants who underwent thoracotomy procedure | 29 Participants | 64 Participants | 35 Participants |
| Number of Participants with a History of Smoking No | 524 Participants | 1044 Participants | 520 Participants |
| Number of Participants with a History of Smoking Unknown | 33 Participants | 57 Participants | 24 Participants |
| Number of Participants with a History of Smoking Yes | 217 Participants | 460 Participants | 243 Participants |
| Number of Participants with a Positive Alcohol Screen No | 474 Participants | 933 Participants | 459 Participants |
| Number of Participants with a Positive Alcohol Screen Not performed | 170 Participants | 380 Participants | 210 Participants |
| Number of Participants with a Positive Alcohol Screen Yes | 130 Participants | 248 Participants | 118 Participants |
| Number of Participants with a Positive Drug Screen No | 316 Participants | 635 Participants | 319 Participants |
| Number of Participants with a Positive Drug Screen Not performed | 256 Participants | 549 Participants | 293 Participants |
| Number of Participants with a Positive Drug Screen Yes | 202 Participants | 377 Participants | 175 Participants |
| Number of participants with flail segment | 57 Participants | 104 Participants | 47 Participants |
| Number of participants with long bone fracture | 249 Participants | 501 Participants | 252 Participants |
| Number of participants with pelvis or acetabulum fracture | 143 Participants | 285 Participants | 142 Participants |
| Number of Participants with Prior Opioid Use No | 685 Participants | 1375 Participants | 690 Participants |
| Number of Participants with Prior Opioid Use Unknown | 37 Participants | 69 Participants | 32 Participants |
| Number of Participants with Prior Opioid Use Yes | 52 Participants | 117 Participants | 65 Participants |
| Number of participants with rib fractures | 356 Participants | 720 Participants | 364 Participants |
| Number of participants with traumatic brain injury | 147 Participants | 305 Participants | 158 Participants |
| Number of participants with vertebral body fracture | 144 Participants | 280 Participants | 136 Participants |
| Number of rib fractures | 0 rib fractures | 0 rib fractures | 0 rib fractures |
| Race/Ethnicity, Customized Black | 167 Participants | 307 Participants | 140 Participants |
| Race/Ethnicity, Customized Hispanic | 223 Participants | 487 Participants | 264 Participants |
| Race/Ethnicity, Customized Other | 21 Participants | 41 Participants | 20 Participants |
| Race/Ethnicity, Customized White | 363 Participants | 726 Participants | 363 Participants |
| Region of Enrollment United States | 774 Participants | 1561 Participants | 787 Participants |
| Score on Abbreviated Injury Scale (AIS) - Abdomen | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Score on Abbreviated Injury Scale (AIS) - Chest | 2 units on a scale | 2 units on a scale | 2 units on a scale |
| Score on Abbreviated Injury Scale (AIS) - Head | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Sex: Female, Male Female | 252 Participants | 500 Participants | 248 Participants |
| Sex: Female, Male Male | 522 Participants | 1061 Participants | 539 Participants |
| Unit of admission Floor | 280 Participants | 585 Participants | 305 Participants |
| Unit of admission Intensive care unit | 279 Participants | 552 Participants | 273 Participants |
| Unit of admission Intermediate unit | 194 Participants | 380 Participants | 186 Participants |
| Unit of admission Other | 21 Participants | 44 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 29 / 787 | 36 / 774 |
| other Total, other adverse events | 0 / 787 | 0 / 774 |
| serious Total, serious adverse events | 29 / 787 | 36 / 774 |
Outcome results
Primary
Opioid Use Per Day
Opioid use per day is calculated by tallying the dose equivalency of all opioids received and dividing by the number of days hospitalized. Morphine milligram equivalents (MME) per day are reported.
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Original MMPR - Descending Dose Arm | Opioid Use Per Day | 48 MME per day |
| MAST MMPR - Escalating Dose Arm | Opioid Use Per Day | 34 MME per day |
Secondary
Degree to Which Function is Limited by Pain as Assessed by Percent of Predicted Daily Incentive Spirometry Volumes (Which is Based on Ideal Body Weight)
Clinical based pain scores ranging from 0 to 10 will be assessed at regular intervals throughout the hospitalization.
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
Population: These data were not collected.
Secondary
Degree to Which Function is Limited by Pain as Indicated by Number of Participants Who Failed to Work With Physical Therapist Due to Pain
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
Population: These data were not collected.
Secondary
Number of Hospital Days
The number of days the patient was hospitalized post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval.
Time frame: 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Original MMPR - Descending Dose Arm | Number of Hospital Days | 4.97 hospital days |
| MAST MMPR - Escalating Dose Arm | Number of Hospital Days | 5.12 hospital days |
Secondary
Number of Intensive Care Unti (ICU) Days
The number of days the patient was in the ICU post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval.
Time frame: 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Original MMPR - Descending Dose Arm | Number of Intensive Care Unti (ICU) Days | 0.21 ICU days |
| MAST MMPR - Escalating Dose Arm | Number of Intensive Care Unti (ICU) Days | 0.21 ICU days |
Secondary
Number of Participants Discharged From the Hospital With an Opioid Prescription
Time frame: Up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Original MMPR - Descending Dose Arm | Number of Participants Discharged From the Hospital With an Opioid Prescription | 527 Participants |
| MAST MMPR - Escalating Dose Arm | Number of Participants Discharged From the Hospital With an Opioid Prescription | 476 Participants |
Secondary
Number of Participants With Any Opioid-related Complications
Opioid-related complications include ileus, aspiration, unplanned intubation, unplanned admission to an intensive care unit, and use of an opioid-reversal agent.
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Original MMPR - Descending Dose Arm | Number of Participants With Any Opioid-related Complications | Unplanned admission to the intensive care unit | 30 Participants |
| Original MMPR - Descending Dose Arm | Number of Participants With Any Opioid-related Complications | Ileus | 41 Participants |
| Original MMPR - Descending Dose Arm | Number of Participants With Any Opioid-related Complications | Cardiac arrest with Cardiopulmonary resuscitation (CPR) | 18 Participants |
| Original MMPR - Descending Dose Arm | Number of Participants With Any Opioid-related Complications | Naloxone reversal | 7 Participants |
| Original MMPR - Descending Dose Arm | Number of Participants With Any Opioid-related Complications | Unplanned intubation | 16 Participants |
| MAST MMPR - Escalating Dose Arm | Number of Participants With Any Opioid-related Complications | Naloxone reversal | 6 Participants |
| MAST MMPR - Escalating Dose Arm | Number of Participants With Any Opioid-related Complications | Unplanned intubation | 16 Participants |
| MAST MMPR - Escalating Dose Arm | Number of Participants With Any Opioid-related Complications | Unplanned admission to the intensive care unit | 31 Participants |
| MAST MMPR - Escalating Dose Arm | Number of Participants With Any Opioid-related Complications | Cardiac arrest with Cardiopulmonary resuscitation (CPR) | 13 Participants |
| MAST MMPR - Escalating Dose Arm | Number of Participants With Any Opioid-related Complications | Ileus | 45 Participants |
Secondary
Number of Ventilator Days
The number of days the patient on a ventilator post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval.
Time frame: 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Original MMPR - Descending Dose Arm | Number of Ventilator Days | 0.08 ventilator days |
| MAST MMPR - Escalating Dose Arm | Number of Ventilator Days | 0.06 ventilator days |
Secondary
Overall Costs
the costs associated with the overall hospitalization or the first 30 days (whichever is sooner) related to post trauma care and complications incurred.
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Original MMPR - Descending Dose Arm | Overall Costs | 20093 dollars |
| MAST MMPR - Escalating Dose Arm | Overall Costs | 19561 dollars |
Secondary
Pain as Assessed by Score on the Behavioral Pain Scale (BPS)
An average will be calculated of the daily score on the Behavioral Pain Scale (BPS). BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants.
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
Population: This data was only collected from 156 in the Original MMPR arm and 150 in the MAST MMPR arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Original MMPR - Descending Dose Arm | Pain as Assessed by Score on the Behavioral Pain Scale (BPS) | 2.5 score on a scale |
| MAST MMPR - Escalating Dose Arm | Pain as Assessed by Score on the Behavioral Pain Scale (BPS) | 2.3 score on a scale |
Secondary
Pain as Assessed by Score on the Numeric Rating Scale (NRS)
An average will be calculated of the daily numeric rating scale (NRS) for pain (0=no pain, 10=worst pain). This assessment is used in verbal participants.
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
Population: This data was only collected from 739 in the Original MMPR arm and 735 in the MAST MMPR arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Original MMPR - Descending Dose Arm | Pain as Assessed by Score on the Numeric Rating Scale (NRS) | 3.3 units on a scale |
| MAST MMPR - Escalating Dose Arm | Pain as Assessed by Score on the Numeric Rating Scale (NRS) | 3.3 units on a scale |
Secondary
Pharmacy Costs
The costs of the pain medications given during the specified time period.
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Original MMPR - Descending Dose Arm | Pharmacy Costs | 507 dollars |
| MAST MMPR - Escalating Dose Arm | Pharmacy Costs | 397 dollars |