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Completed

NCT Number: NCT03472469

MAST Trial: Multi-modal Analgesic Strategies in Trauma

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].

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Key information

Conditions

Nonspecific Pain Post Traumatic Injury

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acetaminophen IV/PO

Drug

Acetaminophen 1g IV/PO every 6 hours

Acetaminophen PO

Drug

Acetaminophen 1g PO every 6 hours

Ketorolac

Drug

Ketorolac 30mg IV once

Celebrex

Drug

Celebrex 200mg PO every 12 hours

Naproxen

Drug

Naproxen 500mg PO every 12 hours

Tramadol

Drug

Tramadol 100mg PO every 6 hours

Pregabalin

Drug

Pregabalin 100mg PO every 8 hours

Gabapentin

Drug

Gabapentin 300mg PO every 8 hours

Lidocaine

Drug

Lidocaine patch every 12 hours

Opioids

Drug

Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)

Regional Anesthesia

Drug

Regional anesthesia

Primary outcomes

  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. Morphine milligram equivalents (MME) per day are reported.

Secondary outcomes

  1. Pain as Assessed by Score on the Numeric Rating Scale (NRS)

    Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)

    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.

  2. Pain as Assessed by Score on the Behavioral Pain Scale (BPS)

    Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)

    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.

  3. Number of Participants Discharged From the Hospital With an Opioid Prescription

    Time frame: Up to 30 days

  4. 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.

  5. 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.

  6. 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.

  7. 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). 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."

  8. 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). 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."

  9. 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). 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."

  10. 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.

  11. 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)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Acronym: MAST

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2018
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.