Nonspecific Pain Post Traumatic Injury Clinical Trial
— MASTOfficial title:
MAST Trial: Multi-modal Analgesic Strategies in Trauma
| Verified date | June 2021 |
| Source | The University of Texas Health Science Center, Houston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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].
| Status | Completed |
| Enrollment | 1561 |
| Est. completion date | July 3, 2019 |
| Est. primary completion date | July 3, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Texas Health Science Center, Houston | National Center for Advancing Translational Science (NCATS) |
United States,
Harvin JA, Albarado R, Truong VTT, Green C, Tyson JE, Pedroza C, Wade CE, Kao LS; MAST Study Group. Multi-Modal Analgesic Strategy for Trauma: A Pragmatic Randomized Clinical Trial. J Am Coll Surg. 2021 Mar;232(3):241-251.e3. doi: 10.1016/j.jamcollsurg.20 — View Citation
Harvin JA, Green CE, Vincent LE, Motley KL, Podbielski J, Miller CC, Tyson JE, Holcomb JB, Wade CE, Kao LS. Multi-modal Analgesic Strategies for Trauma (MAST): protocol for a pragmatic randomized trial. Trauma Surg Acute Care Open. 2018 Aug 19;3(1):e000192. doi: 10.1136/tsaco-2018-000192. eCollection 2018. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | until discharge from hospital or 30 days post admission (whichever is sooner) | |
| 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. | until discharge from hospital or 30 days post admission (whichever is sooner) | |
| 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. | until discharge from hospital or 30 days post admission (whichever is sooner) | |
| Secondary | Number of Participants Discharged From the Hospital With an Opioid Prescription | Up to 30 days | ||
| 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. | until discharge from hospital or 30 days post admission (whichever is sooner) | |
| 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. | until discharge from hospital or 30 days post admission (whichever is sooner) | |
| Secondary | Pharmacy Costs | The costs of the pain medications given during the specified time period. | until discharge from hospital or 30 days post admission (whichever is sooner) | |
| 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." | 30 days | |
| 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." | 30 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." | 30 days | |
| 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. | until discharge from hospital or 30 days post admission (whichever is sooner) | |
| 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 | until discharge from hospital or 30 days post admission (whichever is sooner) |