Nonspecific Pain Post Traumatic InjuryPhase 4MASTNCT03472469

MAST Trial: Multi-modal Analgesic Strategies in Trauma

A Phase 4 study testing Acetaminophen IV/PO, Acetaminophen PO and Ketorolac in people with Nonspecific Pain Post Traumatic Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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]. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Nonspecific Pain Post Traumatic Injury
What is being tested?: Acetaminophen IV/PO, Acetaminophen PO and Ketorolac
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,561 participants
Where: 1 siteUnited States
Study dates: 2 Apr 2018to 3 Jul 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

All patients admitted to the trauma service who are 16 years and older.

Who cannot join

pregnant
prisoner
patients placed in observation (i.e. not admitted to the hospital)

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Conditions: Nonspecific Pain Post Traumatic Injury
Being tested: Acetaminophen IV/PO, Acetaminophen PO, Ketorolac, Celebrex, Naproxen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acetaminophen IV/PODrug
Acetaminophen 1g IV/PO every 6 hours
Acetaminophen PODrug
Acetaminophen 1g PO every 6 hours
KetorolacDrug
Ketorolac 30mg IV once
CelebrexDrug
Celebrex 200mg PO every 12 hours
NaproxenDrug
Naproxen 500mg PO every 12 hours
TramadolDrug
Tramadol 100mg PO every 6 hours
PregabalinDrug
Pregabalin 100mg PO every 8 hours
GabapentinDrug
Gabapentin 300mg PO every 8 hours
LidocaineDrug
Lidocaine patch every 12 hours
OpioidsDrug
Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)
Regional anesthesiaDrug
Regional anesthesia

Study groups in NCT03472469
Study group	Role	What they receive
Original MMPR - descending dose arm	Active comparator	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. Receives: 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
MAST MMPR - escalating dose arm	Active comparator	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. Receives: Drug: Acetaminophen PO; Drug: Ketorolac; Drug: Naproxen; Drug: Gabapentin; Drug: Lidocaine; Drug: Opioids; Drug: Regional anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: until discharge from hospital or 30 days post admission (whichever is sooner)

Secondary outcomes (11)

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.
Measured: until discharge from hospital or 30 days post admission (whichever is sooner)
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.
Measured: until discharge from hospital or 30 days post admission (whichever is sooner)
Number of Participants Discharged From the Hospital With an Opioid Prescription
Measured: Up to 30 days
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.
Measured: until discharge from hospital or 30 days post admission (whichever is sooner)
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.
Measured: until discharge from hospital or 30 days post admission (whichever is sooner)
Pharmacy Costs
The costs of the pain medications given during the specified time period.
Measured: until discharge from hospital or 30 days post admission (whichever is sooner)
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."
Measured: 30 days
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."
Measured: 30 days
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."
Measured: 30 days
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.
Measured: until discharge from hospital or 30 days post admission (whichever is sooner)
Degree to Which Function is Limited by Pain as Indicated by Number of Participants Who Failed to Work With Physical Therapist Due to Pain
Measured: until discharge from hospital or 30 days post admission (whichever is sooner)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 20183 Jul 2019

First posted21 Mar 2018
Study start2 Apr 2018
Primary completion3 Jul 2019
Study completion3 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Nonspecific Pain Post Traumatic InjuryStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,561 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03472469
Sponsor's protocol ID: HSC-MS-18-0036
Other IDs: KL2TR000370, UL1TR000371
Acronym: MAST
Status last verified: Jun 2021
First submitted: 13 Mar 2018
Last updated: 18 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 30206549
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.
PubMed 33486130

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MAST Trial: Multi-modal Analgesic Strategies in Trauma
ClinicalTrials.gov ID: NCT03472469
Acronym / sponsor ID: MAST / HSC-MS-18-0036
Conditions: Nonspecific Pain Post Traumatic Injury
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,561 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 2 Apr 2018 (actual)
Primary completion: 3 Jul 2019 (actual)
Study completion: 3 Jul 2019 (actual)
First posted: 21 Mar 2018 (actual)
Results: Posted 10 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Original MMPR - descending dose arm	Active comparator	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 anesthesiaDrugs 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	Active comparator	Drug: Acetaminophen PO, Drug: Ketorolac, Drug: Naproxen, Drug: Gabapentin, Drug: Lidocaine, Drug: Opioids, Drug: Regional anesthesiaDrugs 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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

All patients admitted to the trauma service who are 16 years and older.

Key exclusion criteria (3 listed)

pregnant
prisoner
patients placed in observation (i.e. not admitted to the hospital)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acetaminophen IV/POAcetaminophen 1g IV/PO every 6 hours	Drug	Original MMPR - descending dose arm
Acetaminophen POAcetaminophen 1g PO every 6 hours	Drug	MAST MMPR - escalating dose arm, Original MMPR - descending dose arm
KetorolacKetorolac 30mg IV once	Drug	MAST MMPR - escalating dose arm, Original MMPR - descending dose arm
CelebrexCelebrex 200mg PO every 12 hours	Drug	Original MMPR - descending dose arm
NaproxenNaproxen 500mg PO every 12 hours	Drug	MAST MMPR - escalating dose arm, Original MMPR - descending dose arm
TramadolTramadol 100mg PO every 6 hours	Drug	Original MMPR - descending dose arm
PregabalinPregabalin 100mg PO every 8 hours	Drug	Original MMPR - descending dose arm
GabapentinGabapentin 300mg PO every 8 hours	Drug	MAST MMPR - escalating dose arm, Original MMPR - descending dose arm
LidocaineLidocaine patch every 12 hours	Drug	MAST MMPR - escalating dose arm, Original MMPR - descending dose arm
OpioidsOpioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)	Drug	MAST MMPR - escalating dose arm, Original MMPR - descending dose arm
Regional anesthesiaRegional anesthesia	Drug	MAST MMPR - escalating dose arm, Original MMPR - descending dose arm

Primary outcome

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.

11 secondary outcomes

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)
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)
Number of Participants Discharged From the Hospital With an Opioid Prescription
Time frame: Up to 30 days
Number of Participants With Any Opioid-related Complications
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
Overall Costs
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
Pharmacy Costs
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
Number of Ventilator Days
Time frame: 30 days
Number of Hospital Days
Time frame: 30 days
Number of Intensive Care Unti (ICU) Days
Time frame: 30 days
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)
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)

Results and safety

Results posted to the registry on 10 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Original MMPR - Descending Dose Arm	787	787
MAST MMPR - Escalating Dose Arm	774	774

Primary outcome: Opioid Use Per Day

Time frame: until discharge from hospital or 30 days post admission (whichever is sooner). Median (Inter-Quartile Range). Unit: MME per day

Measure	Original MMPR - Descending Dose Arm n = 787	MAST MMPR - Escalating Dose Arm n = 774
Value	48 (22 to 74)	34 (15 to 61)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From hospital admission to hospital discharge (about 30 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Original MMPR - Descending Dose Arm	29 of 787 (3.7%)	0 of 787 (0%)	29 of 787
MAST MMPR - Escalating Dose Arm	36 of 774 (4.7%)	0 of 774 (0%)	36 of 774

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30206549Harvin 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 publication: PubMed 33486130Harvin 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Harvin, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Use Per Day (time frame: until discharge from hospital or 30 days post admission (whichever is sooner)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03472469, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.