MAST Trial: Multi-modal Analgesic Strategies in Trauma
MAST
3 other identifiers
interventional
1,561
1 country
1
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 \[original multimodal pain regimen (MMPR) compared to multi-modal analgesic strategies for trauma (MAST) MMPR\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2018
CompletedFirst Posted
Study publicly available on registry
March 21, 2018
CompletedStudy Start
First participant enrolled
April 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2019
CompletedResults Posted
Study results publicly available
June 10, 2021
CompletedJune 18, 2021
June 1, 2021
1.3 years
March 13, 2018
May 16, 2021
June 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Pain as Assessed by Score on the Numeric Rating Scale (NRS)
until discharge from hospital or 30 days post admission (whichever is sooner)
Pain as Assessed by Score on the Behavioral Pain Scale (BPS)
until discharge from hospital or 30 days post admission (whichever is sooner)
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)
Overall Costs
until discharge from hospital or 30 days post admission (whichever is sooner)
- +6 more secondary outcomes
Study Arms (2)
Original MMPR - descending dose arm
ACTIVE COMPARATORDrugs 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.
MAST MMPR - escalating dose arm
ACTIVE COMPARATORDrugs 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.
Interventions
Acetaminophen 1g PO every 6 hours
Ketorolac 30mg IV once
Naproxen 500mg PO every 12 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
Eligibility Criteria
You may qualify if:
- All patients admitted to the trauma service who are 16 years and older.
You may not qualify if:
- pregnant
- prisoner
- patients placed in observation (i.e. not admitted to the hospital)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Related Publications (2)
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.
PMID: 30206549BACKGROUNDHarvin 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.2020.12.014. Epub 2021 Jan 21.
PMID: 33486130RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John A. Harvin, MD
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
John Harvin, MD
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 13, 2018
First Posted
March 21, 2018
Study Start
April 2, 2018
Primary Completion
July 3, 2019
Study Completion
July 3, 2019
Last Updated
June 18, 2021
Results First Posted
June 10, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share