Trial Outcomes & Findings for MAST Trial: Multi-modal Analgesic Strategies in Trauma (NCT NCT03472469)
NCT ID: NCT03472469
Last Updated: 2021-06-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1561 participants
Primary outcome timeframe
until discharge from hospital or 30 days post admission (whichever is sooner)
Results posted on
2021-06-18
Participant Flow
Participant milestones
| Measure |
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.
|
MAST MMPR - Escalating Dose Arm
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.
|
|---|---|---|
|
Overall Study
STARTED
|
787
|
774
|
|
Overall Study
COMPLETED
|
787
|
774
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MAST Trial: Multi-modal Analgesic Strategies in Trauma
Baseline characteristics by cohort
| Measure |
Original MMPR - Descending Dose Arm
n=787 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=774 Participants
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
n=1561 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
45 years
n=7 Participants
|
45 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
248 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
539 Participants
n=5 Participants
|
522 Participants
n=7 Participants
|
1061 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
140 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
264 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
487 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
363 Participants
n=5 Participants
|
363 Participants
n=7 Participants
|
726 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
787 Participants
n=5 Participants
|
774 Participants
n=7 Participants
|
1561 Participants
n=5 Participants
|
|
Number of Participants with Prior Opioid Use
No
|
690 Participants
n=5 Participants
|
685 Participants
n=7 Participants
|
1375 Participants
n=5 Participants
|
|
Number of Participants with Prior Opioid Use
Yes
|
65 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Number of Participants with Prior Opioid Use
Unknown
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Number of Participants with a History of Smoking
No
|
520 Participants
n=5 Participants
|
524 Participants
n=7 Participants
|
1044 Participants
n=5 Participants
|
|
Number of Participants with a History of Smoking
Yes
|
243 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
460 Participants
n=5 Participants
|
|
Number of Participants with a History of Smoking
Unknown
|
24 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Number of Participants with a Positive Alcohol Screen
No
|
459 Participants
n=5 Participants
|
474 Participants
n=7 Participants
|
933 Participants
n=5 Participants
|
|
Number of Participants with a Positive Alcohol Screen
Yes
|
118 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Number of Participants with a Positive Alcohol Screen
Not performed
|
210 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
380 Participants
n=5 Participants
|
|
Number of Participants with a Positive Drug Screen
No
|
319 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
635 Participants
n=5 Participants
|
|
Number of Participants with a Positive Drug Screen
Yes
|
175 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
377 Participants
n=5 Participants
|
|
Number of Participants with a Positive Drug Screen
Not performed
|
293 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
549 Participants
n=5 Participants
|
|
Score on Abbreviated Injury Scale (AIS) - Head
|
0 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
0 units on a scale
n=5 Participants
|
|
Score on Abbreviated Injury Scale (AIS) - Chest
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
|
Score on Abbreviated Injury Scale (AIS) - Abdomen
|
0 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
0 units on a scale
n=5 Participants
|
|
Injury Severity Score (ISS)
|
14 units on a scale
n=5 Participants
|
14 units on a scale
n=7 Participants
|
14 units on a scale
n=5 Participants
|
|
Number of participants with rib fractures
|
364 Participants
n=5 Participants
|
356 Participants
n=7 Participants
|
720 Participants
n=5 Participants
|
|
Number of rib fractures
|
0 rib fractures
n=5 Participants
|
0 rib fractures
n=7 Participants
|
0 rib fractures
n=5 Participants
|
|
Number of participants with flail segment
|
47 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Number of participants with long bone fracture
|
252 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
501 Participants
n=5 Participants
|
|
Number of participants with vertebral body fracture
|
136 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Number of participants with pelvis or acetabulum fracture
|
142 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Number of participants with traumatic brain injury
|
158 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Unit of admission
Floor
|
305 Participants
n=5 Participants
|
280 Participants
n=7 Participants
|
585 Participants
n=5 Participants
|
|
Unit of admission
Intermediate unit
|
186 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
380 Participants
n=5 Participants
|
|
Unit of admission
Intensive care unit
|
273 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
552 Participants
n=5 Participants
|
|
Unit of admission
Other
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Number of participants who underwent laparotomy procedure
|
96 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Number of participants who underwent thoracotomy procedure
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Number of participants who underwent amputation procedure
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Original MMPR - Descending Dose Arm
n=787 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=774 Participants
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.
|
|---|---|---|
|
Opioid Use Per Day
|
48 MME per day
Interval 22.0 to 74.0
|
34 MME per day
Interval 15.0 to 61.0
|
SECONDARY outcome
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)Population: This data was only collected from 739 in the Original MMPR arm and 735 in the MAST MMPR arm.
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.
Outcome measures
| Measure |
Original MMPR - Descending Dose Arm
n=739 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=735 Participants
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.
|
|---|---|---|
|
Pain as Assessed by Score on the Numeric Rating Scale (NRS)
|
3.3 units on a scale
Interval 1.8 to 4.8
|
3.3 units on a scale
Interval 1.8 to 4.7
|
SECONDARY outcome
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)Population: This data was only collected from 156 in the Original MMPR arm and 150 in the MAST MMPR arm.
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.
Outcome measures
| Measure |
Original MMPR - Descending Dose Arm
n=156 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=150 Participants
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.
|
|---|---|---|
|
Pain as Assessed by Score on the Behavioral Pain Scale (BPS)
|
2.5 score on a scale
Interval 2.1 to 3.0
|
2.3 score on a scale
Interval 1.8 to 3.0
|
SECONDARY outcome
Timeframe: Up to 30 daysOutcome measures
| Measure |
Original MMPR - Descending Dose Arm
n=787 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=774 Participants
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.
|
|---|---|---|
|
Number of Participants Discharged From the Hospital With an Opioid Prescription
|
527 Participants
|
476 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Original MMPR - Descending Dose Arm
n=787 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=774 Participants
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.
|
|---|---|---|
|
Number of Participants With Any Opioid-related Complications
Unplanned intubation
|
16 Participants
|
16 Participants
|
|
Number of Participants With Any Opioid-related Complications
Cardiac arrest with Cardiopulmonary resuscitation (CPR)
|
18 Participants
|
13 Participants
|
|
Number of Participants With Any Opioid-related Complications
Ileus
|
41 Participants
|
45 Participants
|
|
Number of Participants With Any Opioid-related Complications
Unplanned admission to the intensive care unit
|
30 Participants
|
31 Participants
|
|
Number of Participants With Any Opioid-related Complications
Naloxone reversal
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Original MMPR - Descending Dose Arm
n=787 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=774 Participants
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.
|
|---|---|---|
|
Overall Costs
|
20093 dollars
Interval 9557.0 to 42492.0
|
19561 dollars
Interval 10238.0 to 44795.0
|
SECONDARY outcome
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)The costs of the pain medications given during the specified time period.
Outcome measures
| Measure |
Original MMPR - Descending Dose Arm
n=787 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=774 Participants
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.
|
|---|---|---|
|
Pharmacy Costs
|
507 dollars
Interval 240.0 to 1098.0
|
397 dollars
Interval 183.0 to 1044.0
|
SECONDARY outcome
Timeframe: 30 daysThe 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."
Outcome measures
| Measure |
Original MMPR - Descending Dose Arm
n=787 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=774 Participants
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.
|
|---|---|---|
|
Number of Ventilator Days
|
0.08 ventilator days
Interval 0.03 to 0.18
|
0.06 ventilator days
Interval 0.03 to 0.14
|
SECONDARY outcome
Timeframe: 30 daysThe 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."
Outcome measures
| Measure |
Original MMPR - Descending Dose Arm
n=787 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=774 Participants
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.
|
|---|---|---|
|
Number of Hospital Days
|
4.97 hospital days
Interval 4.59 to 5.38
|
5.12 hospital days
Interval 4.72 to 5.55
|
SECONDARY outcome
Timeframe: 30 daysThe 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."
Outcome measures
| Measure |
Original MMPR - Descending Dose Arm
n=787 Participants
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.
|
MAST MMPR - Escalating Dose Arm
n=774 Participants
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.
|
|---|---|---|
|
Number of Intensive Care Unti (ICU) Days
|
0.21 ICU days
Interval 0.12 to 0.34
|
0.21 ICU days
Interval 0.13 to 0.35
|
SECONDARY outcome
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)Population: These data were not collected.
Clinical based pain scores ranging from 0 to 10 will be assessed at regular intervals throughout the hospitalization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)Population: These data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Original MMPR - Descending Dose Arm
Serious events: 29 serious events
Other events: 0 other events
Deaths: 29 deaths
MAST MMPR - Escalating Dose Arm
Serious events: 36 serious events
Other events: 0 other events
Deaths: 36 deaths
Serious adverse events
| Measure |
Original MMPR - Descending Dose Arm
n=787 participants at risk
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.
|
MAST MMPR - Escalating Dose Arm
n=774 participants at risk
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.
|
|---|---|---|
|
General disorders
Death
|
3.7%
29/787 • Number of events 787 • From hospital admission to hospital discharge (about 30 days)
|
4.7%
36/774 • Number of events 774 • From hospital admission to hospital discharge (about 30 days)
|
Other adverse events
Adverse event data not reported
Additional Information
John A. Harvin, MD
The University of Texas Health Science Center at Houston
Phone: (713) 500-7244
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place