MAST Trial: Multi-modal Analgesic Strategies in Trauma

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03472469
• Collaborator: National Center for Advancing Translational Science (NCATS) (NIH)
• Enrollment: 1,561
• Location: 1
• Arms: 2
• Actual Duration (Months): 15
• Patients Per Site Per Month: 104

Study Details

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].

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 Design

• Study Type: Interventional
• Actual Enrollment: 1561 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MAST Trial: Multi-modal Analgesic Strategies in Trauma
• Actual Study Start Date: Apr 2, 2018
• Actual Primary Completion Date: Jul 3, 2019
• Actual Study Completion Date: Jul 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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; Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl); Drug: Regional anesthesia; Regional anesthesia
Active Comparator: 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.	Drug: Acetaminophen PO; Acetaminophen 1g PO every 6 hours; Drug: Ketorolac; Ketorolac 30mg IV once; Drug: Naproxen; Naproxen 500mg PO every 12 hours; Drug: Gabapentin; Gabapentin 300mg PO every 8 hours; Drug: Lidocaine; Lidocaine patch every 12 hours; Drug: Opioids; Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl); Drug: Regional anesthesia; Regional anesthesia

Outcome Measures

Primary Outcome Measures

1. Opioid Use Per Day [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 Outcome Measures

1. Pain as Assessed by Score on the Numeric Rating Scale (NRS) [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) [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 [Up to 30 days]

4. Number of Participants With Any Opioid-related Complications [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 [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 [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 [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 [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 [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) [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 [until discharge from hospital or 30 days post admission (whichever is sooner)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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
• National Center for Advancing Translational Science (NCATS)

Investigators

• Principal Investigator: John Harvin, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 2, 2018

More Information

Publications

• 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.

• Responsible Party: John Andrew Harvin, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03472469
• Other Study ID Numbers: HSC-MS-18-0036; KL2TR000370; UL1TR000371
• First Posted: Mar 21, 2018
• Last Update Posted: Jun 18, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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; Acetaminophen; Ketorolac; Naproxen; Celecoxib; Lidocaine; Pregabalin; Gabapentin; Tramadol

Study Results

Participant Flow

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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 intravenously 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.
Period Title: Overall Study
STARTED	787	774
COMPLETED	787	774
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm	Total
Arm/Group 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.	Total of all reporting groups
Overall Participants	787	774	1561
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	44	45	45
Sex: Female, Male (Count of Participants)
Female	248 31.5%	252 32.6%	500 32%
Male	539 68.5%	522 67.4%	1061 68%
Race/Ethnicity, Customized (Count of Participants)
Black	140 17.8%	167 21.6%	307 19.7%
Hispanic	264 33.5%	223 28.8%	487 31.2%
Other	20 2.5%	21 2.7%	41 2.6%
White	363 46.1%	363 46.9%	726 46.5%
Region of Enrollment (Count of Participants)
United States	787 100%	774 100%	1561 100%
Number of Participants with Prior Opioid Use (Count of Participants)
No	690 87.7%	685 88.5%	1375 88.1%
Yes	65 8.3%	52 6.7%	117 7.5%
Unknown	32 4.1%	37 4.8%	69 4.4%
Number of Participants with a History of Smoking (Count of Participants)
No	520 66.1%	524 67.7%	1044 66.9%
Yes	243 30.9%	217 28%	460 29.5%
Unknown	24 3%	33 4.3%	57 3.7%
Number of Participants with a Positive Alcohol Screen (Count of Participants)
No	459 58.3%	474 61.2%	933 59.8%
Yes	118 15%	130 16.8%	248 15.9%
Not performed	210 26.7%	170 22%	380 24.3%
Number of Participants with a Positive Drug Screen (Count of Participants)
No	319 40.5%	316 40.8%	635 40.7%
Yes	175 22.2%	202 26.1%	377 24.2%
Not performed	293 37.2%	256 33.1%	549 35.2%
Score on Abbreviated Injury Scale (AIS) - Head (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	0	0	0
Score on Abbreviated Injury Scale (AIS) - Chest (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	2	2	2
Score on Abbreviated Injury Scale (AIS) - Abdomen (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	0	0	0
Injury Severity Score (ISS) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	14	14	14
Number of participants with rib fractures (Count of Participants)
Count of Participants [Participants]	364 46.3%	356 46%	720 46.1%
Number of rib fractures (rib fractures) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [rib fractures]	0	0	0
Number of participants with flail segment (Count of Participants)
Count of Participants [Participants]	47 6%	57 7.4%	104 6.7%
Number of participants with long bone fracture (Count of Participants)
Count of Participants [Participants]	252 32%	249 32.2%	501 32.1%
Number of participants with vertebral body fracture (Count of Participants)
Count of Participants [Participants]	136 17.3%	144 18.6%	280 17.9%
Number of participants with pelvis or acetabulum fracture (Count of Participants)
Count of Participants [Participants]	142 18%	143 18.5%	285 18.3%
Number of participants with traumatic brain injury (Count of Participants)
Count of Participants [Participants]	158 20.1%	147 19%	305 19.5%
Unit of admission (Count of Participants)
Floor	305 38.8%	280 36.2%	585 37.5%
Intermediate unit	186 23.6%	194 25.1%	380 24.3%
Intensive care unit	273 34.7%	279 36%	552 35.4%
Other	23 2.9%	21 2.7%	44 2.8%
Number of participants who underwent laparotomy procedure (Count of Participants)
Count of Participants [Participants]	96 12.2%	86 11.1%	182 11.7%
Number of participants who underwent thoracotomy procedure (Count of Participants)
Count of Participants [Participants]	35 4.4%	29 3.7%	64 4.1%
Number of participants who underwent amputation procedure (Count of Participants)
Count of Participants [Participants]	9 1.1%	12 1.6%	21 1.3%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	787	774
Median (Inter-Quartile Range) [MME per day]	48	34

2. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

This data was only collected from 739 in the Original MMPR arm and 735 in the MAST MMPR arm.

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	739	735
Median (Inter-Quartile Range) [units on a scale]	3.3	3.3

3. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

This data was only collected from 156 in the Original MMPR arm and 150 in the MAST MMPR arm.

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	156	150
Median (Inter-Quartile Range) [score on a scale]	2.5	2.3

4. Secondary Outcome

Title	Number of Participants Discharged From the Hospital With an Opioid Prescription
Time Frame	Up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	787	774
Count of Participants [Participants]	527 67%	476 61.5%

5. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	787	774
Unplanned intubation	16 2%	16 2.1%
Unplanned admission to the intensive care unit	30 3.8%	31 4%
Cardiac arrest with Cardiopulmonary resuscitation (CPR)	18 2.3%	13 1.7%
Ileus	41 5.2%	45 5.8%
Naloxone reversal	7 0.9%	6 0.8%

6. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	787	774
Median (Inter-Quartile Range) [dollars]	20093	19561

7. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	787	774
Median (Inter-Quartile Range) [dollars]	507	397

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	787	774
Mean (95% Confidence Interval) [ventilator days]	0.08	0.06

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	787	774
Mean (95% Confidence Interval) [hospital days]	4.97	5.12

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	787	774
Mean (95% Confidence Interval) [ICU days]	0.21	0.21

11. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

These data were not collected.

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	0	0

12. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

These data were not collected.

Arm/Group Title	Original MMPR - Descending Dose Arm	MAST MMPR - Escalating Dose Arm
Arm/Group 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.
Measure Participants	0	0

Adverse Events

Time Frame	From hospital admission to hospital discharge (about 30 days)
Arm/Group Title	Original MMPR - Descending Dose Arm		MAST MMPR - Escalating Dose Arm
Arm/Group 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.
All Cause Mortality
	Original MMPR - Descending Dose Arm		MAST MMPR - Escalating Dose Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/787 (3.7%)		36/774 (4.7%)
Serious Adverse Events
	Original MMPR - Descending Dose Arm		MAST MMPR - Escalating Dose Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/787 (3.7%)		36/774 (4.7%)
General disorders
Death	29/787 (3.7%)	787	36/774 (4.7%)	774
Other (Not Including Serious) Adverse Events
	Original MMPR - Descending Dose Arm		MAST MMPR - Escalating Dose Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/787 (0%)		0/774 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.