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 \[original multimodal pain regimen (MMPR) compared to multi-modal analgesic strategies for trauma (MAST) MMPR\].
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,561
Acetaminophen 1g IV/PO every 6 hours
Acetaminophen 1g PO every 6 hours
Ketorolac 30mg IV once
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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)
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)
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)
Number of Participants Discharged From the Hospital With an Opioid Prescription
Time frame: Up to 30 days
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)
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)
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Celebrex 200mg PO every 12 hours
Naproxen 500mg PO every 12 hours
Tramadol 100mg PO every 6 hours
Pregabalin 100mg PO every 8 hours
Gabapentin 300mg PO every 8 hours
Lidocaine patch every 12 hours
Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)
Regional anesthesia
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)
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
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
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
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)
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)