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Trial record 2 of 110 for:    MAST

MAST Trial: Multi-modal Analgesic Strategies in Trauma (MAST)

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ClinicalTrials.gov Identifier: NCT03472469
Recruitment Status : Enrolling by invitation
First Posted : March 21, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
John Andrew Harvin, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Nonspecific Pain Post Traumatic Injury Drug: Acetaminophen IV/PO Drug: Acetaminophen PO Drug: Ketorolac Drug: Celebrex Drug: Naproxen Drug: Tramadol Drug: Pregabalin Drug: Gabapentin Drug: Lidocaine Drug: Opioids Drug: Regional anesthesia Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: MAST Trial: Multi-modal Analgesic Strategies in Trauma
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment Strategy #1 - descending dose arm
Treatment Strategy #1 is the descending dose arm. Inclusion in this arm will involve one of the following 6 drug combinations, and the treating physician will choose strategy. The 6 strategies are: 1. Acetaminophen 1g intravenous (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.
Drug: Acetaminophen IV/PO
Acetaminophen 1g IV/PO every 6 hours

Drug: Acetaminophen PO
Acetaminophen 1g PO every 6 hours

Drug: Ketorolac
Ketorolac 30mg IV once

Drug: Celebrex
Celebrex 200mg PO every 12 hours

Drug: Naproxen
Naproxen 500mg PO every 12 hours

Drug: Tramadol
Tramadol 100mg PO every 6 hours

Drug: Pregabalin
Pregabalin 100mg PO every 8 hours

Drug: Gabapentin
Gabapentin 300mg PO every 8 hours

Drug: Lidocaine
Lidocaine patch every 12 hours

Drug: Opioids
Opioids

Drug: Regional anesthesia
Regional anesthesia

Active Comparator: Treatment Strategy #2 - escalating dose arm
Treatment Strategy #2 is the escalating dose arm. Inclusion in this arm will involve one of the following 6 drug combinations, and the treating physician will choose strategy. The 6 strategies are: 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; 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.
Drug: Acetaminophen PO
Acetaminophen 1g PO every 6 hours

Drug: Ketorolac
Ketorolac 30mg IV once

Drug: Naproxen
Naproxen 500mg PO every 12 hours

Drug: Tramadol
Tramadol 100mg PO every 6 hours

Drug: Gabapentin
Gabapentin 300mg PO every 8 hours

Drug: Lidocaine
Lidocaine patch every 12 hours

Drug: Opioids
Opioids

Drug: Regional anesthesia
Regional anesthesia




Primary Outcome Measures :
  1. Opioid use per day [ Time Frame: 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.


Secondary Outcome Measures :
  1. Pain score [ Time Frame: until discharge from hospital or 30 days post admission (whichever is sooner) ]
    an average will be calculated of the average daily numeric rating scale of pain (0=no pain, 10=worst pain).

  2. Number of participants discharged from the hospital with an opioid prescription [ Time Frame: Up to 30 days ]
  3. Number of participants with any opioid-related complications [ Time Frame: 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.

  4. Overall costs [ Time Frame: 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.

  5. Pharmacy costs [ Time Frame: until discharge from hospital or 30 days post admission (whichever is sooner) ]
    The costs of the pain medications given during the specified time period.

  6. Number of ventilator days [ Time Frame: 30 days ]
    The number of days the patient on a ventilator post injury or up to 30 days (whichever is sooner)

  7. Number of hospital days [ Time Frame: 30 days ]
    The number of days the patient was hospitalized post injury or up to 30 days (whichever is sooner)

  8. Number of intensive care unti (ICU) days [ Time Frame: 30 days ]
    The number of days the patient was in the ICU post injury or up to 30 days (whichever is sooner)

  9. 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) [ Time Frame: 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.

  10. 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) ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472469


Locations
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: John Harvin, MD The University of Texas Health Science Center, Houston

Responsible Party: John Andrew Harvin, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03472469     History of Changes
Other Study ID Numbers: HSC-MS-18-0036
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Wounds and Injuries
Anesthetics
Lidocaine
Pregabalin
Gabapentin
Tramadol
Acetaminophen
Ketorolac
Ketorolac Tromethamine
Naproxen
Celecoxib
Analgesics, Opioid
Analgesics
gamma-Aminobutyric Acid
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics, Non-Narcotic
Antipyretics
Anticonvulsants
Calcium Channel Blockers
Anti-Anxiety Agents