Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1561 participants
INTERVENTIONAL
2018-04-02
2019-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Acetaminophen IV/PO
Acetaminophen 1g IV/PO every 6 hours
Acetaminophen PO
Acetaminophen 1g PO every 6 hours
Ketorolac
Ketorolac 30mg IV once
Celebrex
Celebrex 200mg PO every 12 hours
Naproxen
Naproxen 500mg PO every 12 hours
Tramadol
Tramadol 100mg PO every 6 hours
Pregabalin
Pregabalin 100mg PO every 8 hours
Gabapentin
Gabapentin 300mg PO every 8 hours
Lidocaine
Lidocaine patch every 12 hours
Opioids
Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)
Regional anesthesia
Regional anesthesia
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.
Acetaminophen PO
Acetaminophen 1g PO every 6 hours
Ketorolac
Ketorolac 30mg IV once
Naproxen
Naproxen 500mg PO every 12 hours
Gabapentin
Gabapentin 300mg PO every 8 hours
Lidocaine
Lidocaine patch every 12 hours
Opioids
Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)
Regional anesthesia
Regional anesthesia
Interventions
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Acetaminophen IV/PO
Acetaminophen 1g IV/PO every 6 hours
Acetaminophen PO
Acetaminophen 1g PO every 6 hours
Ketorolac
Ketorolac 30mg IV once
Celebrex
Celebrex 200mg PO every 12 hours
Naproxen
Naproxen 500mg PO every 12 hours
Tramadol
Tramadol 100mg PO every 6 hours
Pregabalin
Pregabalin 100mg PO every 8 hours
Gabapentin
Gabapentin 300mg PO every 8 hours
Lidocaine
Lidocaine patch every 12 hours
Opioids
Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)
Regional anesthesia
Regional anesthesia
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* prisoner
* patients placed in observation (i.e. not admitted to the hospital)
16 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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John Andrew Harvin
Assistant Professor
Principal Investigators
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John Harvin, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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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.
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.2020.12.014. Epub 2021 Jan 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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