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

Primary Purpose

Nonspecific Pain Post Traumatic Injury

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen IV/PO
Acetaminophen PO
Ketorolac
Celebrex
Naproxen
Tramadol
Pregabalin
Gabapentin
Lidocaine
Opioids
Regional anesthesia
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonspecific Pain Post Traumatic Injury

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Original MMPR - descending dose arm

MAST MMPR - escalating dose arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of Participants Discharged From the Hospital With an Opioid Prescription
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.
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.
Pharmacy Costs
The costs of the pain medications given during the specified time period.
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."
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."
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."
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.
Degree to Which Function is Limited by Pain as Indicated by Number of Participants Who Failed to Work With Physical Therapist Due to Pain

Full Information

First Posted
March 13, 2018
Last Updated
June 15, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT03472469
Brief Title
MAST Trial: Multi-modal Analgesic Strategies in Trauma
Acronym
MAST
Official Title
MAST Trial: Multi-modal Analgesic Strategies in Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
July 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

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

5. Study Description

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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonspecific Pain Post Traumatic Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1561 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Original MMPR - descending dose arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MAST MMPR - escalating dose arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen IV/PO
Intervention Description
Acetaminophen 1g IV/PO every 6 hours
Intervention Type
Drug
Intervention Name(s)
Acetaminophen PO
Intervention Description
Acetaminophen 1g PO every 6 hours
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
Ketorolac 30mg IV once
Intervention Type
Drug
Intervention Name(s)
Celebrex
Intervention Description
Celebrex 200mg PO every 12 hours
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Naproxen 500mg PO every 12 hours
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
Tramadol 100mg PO every 6 hours
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin 100mg PO every 8 hours
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 300mg PO every 8 hours
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine patch every 12 hours
Intervention Type
Drug
Intervention Name(s)
Opioids
Intervention Description
Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)
Intervention Type
Drug
Intervention Name(s)
Regional anesthesia
Intervention Description
Regional anesthesia
Primary Outcome Measure Information:
Title
Opioid Use Per Day
Description
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)
Secondary Outcome Measure Information:
Title
Pain as Assessed by Score on the Numeric Rating Scale (NRS)
Description
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)
Title
Pain as Assessed by Score on the Behavioral Pain Scale (BPS)
Description
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)
Title
Number of Participants Discharged From the Hospital With an Opioid Prescription
Time Frame
Up to 30 days
Title
Number of Participants With Any Opioid-related Complications
Description
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)
Title
Overall Costs
Description
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)
Title
Pharmacy Costs
Description
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)
Title
Number of Ventilator Days
Description
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
Title
Number of Hospital Days
Description
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
Title
Number of Intensive Care Unti (ICU) Days
Description
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
Title
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)
Description
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Harvin, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30206549
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.
Results Reference
background
PubMed Identifier
33486130
Citation
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.
Results Reference
result

Learn more about this trial

MAST Trial: Multi-modal Analgesic Strategies in Trauma

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