A Phase 4 interventional study of Acetaminophen IV/PO and Acetaminophen PO in Nonspecific Pain Post Traumatic Injury, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
Among 137 studies testing acetaminophen in Pain — 5 open to participants now, 5 under way, none of them phase 3. Acetaminophen · Pain.
Among the 137 studies testing acetaminophen in Pain, this one has the largest enrollment, is one of 8 that started in 2018, is one of 67 in phase 4, and was the 104th registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 1,561 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →5 of the 137 studies testing acetaminophen in Pain are open now, in 3 countries. Each count lists the studies.
Acetaminophen: first FDA approval 1968 (NEOPAP). What it is approved for, and how studies give it, is on its page →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 16 Years and older · all sexes · no healthy volunteers.
The full table on the hub →137 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 8 started in 2018.
Median enrollment 95 across the 137 interventional studies. Of the 115 that completed or were terminated, 53 (46%) have results posted.
39 of 137 have an industry lead sponsor. The 10 most frequent:
The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
16 studies in Pain by The University of Texas Health Science Center, Houston: 2 open now, 2 under way, none of them phase 3. Of 11 finished, 9 (82%) have results posted.
Among the 16 studies in Pain by The University of Texas Health Science Center, Houston, this one has the largest enrollment of the 15 interventional ones, is one of 2 that started in 2018, is one of 8 in phase 4, and was the 10th registered.
The University of Texas Health Science Center, Houston’s Pain studies by the year they started, since 2009.
4 of the studies testing acetaminophen in Pain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07512297University of GaziantepPain Control During ESWL Using Non-Opioid Analgesics | 2027-01-01 |
| NCT07368738Horizon Health NetworkIntravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy | 2027-04 |
| NCT06613178McGill University Health Centre/Research Institute of the McGill University Health CentreIntravenous Acetaminophen After Cardiac Surgery - Definitive Study | 2027-07-01 |
| NCT07536425Western Galilee Hospital-NahariyaPreoperative Indomethacin and Paracetamol for Pain Management During Oocyte Retrieval in IVF Patients | 2027-10-30 |
Among the 137 studies testing acetaminophen in Pain, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among The University of Texas Health Science Center, Houston’s 16 in Pain:
Nothing recorded among them since 2026-09-25.
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].
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · Drug: Acetaminophen PO · Drug: Ketorolac · Drug: Celebrex · Drug: Naproxen · Drug: Tramadol · Drug: Pregabalin · Drug: Gabapentin · Drug: Lidocaine · Drug: Opioids · Drug: Regional anesthesia
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 · Drug: Ketorolac · Drug: Naproxen · Drug: Gabapentin · Drug: Lidocaine · Drug: Opioids · Drug: Regional anesthesia
Drug page: Acetaminophen
Acetaminophen 1g IV/PO every 6 hours
Acetaminophen 1g PO every 6 hours
Ketorolac 30mg IV once
Celebrex 200mg PO every 12 hours
Naproxen 500mg PO every 12 hours
Tramadol 100mg PO every 6 hours
Pregabalin 100mg PO every 8 hours
Gabapentin 300mg PO every 8 hours
Lidocaine patch every 12 hours
Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)
Regional anesthesia
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.
Time frame: until discharge from hospital or 30 days post admission (whichever is sooner)
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.
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)
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)
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
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)
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.
Time frame: 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.
Time frame: 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."
Time frame: 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."
Time frame: 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."
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)
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)
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)
| Milestone | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Started | 787 | 774 |
| Completed | 787 | 774 |
| Not completed | 0 | 0 |
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.
| MME per day | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Opioid Use Per Day | 48 (22 to 74) | 34 (15 to 61) |
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.
| units on a scale | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Pain as Assessed by Score on the Numeric Rating Scale (NRS) | 3.3 (1.8 to 4.8) | 3.3 (1.8 to 4.7) |
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.
| score on a scale | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Pain as Assessed by Score on the Behavioral Pain Scale (BPS) | 2.5 (2.1 to 3.0) | 2.3 (1.8 to 3.0) |
| Participants | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Number of Participants Discharged From the Hospital With an Opioid Prescription | 527 | 476 |
Opioid-related complications include ileus, aspiration, unplanned intubation, unplanned admission to an intensive care unit, and use of an opioid-reversal agent.
| Participants | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Unplanned intubation | 16 | 16 |
| Unplanned admission to the intensive care unit | 30 | 31 |
| Cardiac arrest with Cardiopulmonary resuscitation (CPR) | 18 | 13 |
| Ileus | 41 | 45 |
| Naloxone reversal | 7 | 6 |
the costs associated with the overall hospitalization or the first 30 days (whichever is sooner) related to post trauma care and complications incurred.
| dollars | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Overall Costs | 20093 (9557 to 42492) | 19561 (10238 to 44795) |
The costs of the pain medications given during the specified time period.
| dollars | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Pharmacy Costs | 507 (240 to 1098) | 397 (183 to 1044) |
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."
| ventilator days | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Number of Ventilator Days | 0.08 (0.03 to 0.18) | 0.06 (0.03 to 0.14) |
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."
| hospital days | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Number of Hospital Days | 4.97 (4.59 to 5.38) | 5.12 (4.72 to 5.55) |
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."
| ICU days | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| Number of Intensive Care Unti (ICU) Days | 0.21 (0.12 to 0.34) | 0.21 (0.13 to 0.35) |
Clinical based pain scores ranging from 0 to 10 will be assessed at regular intervals throughout the hospitalization.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over From hospital admission to hospital discharge (about 30 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Original MMPR - Descending Dose Arm | 29/787 (3.7%) | 29/787 (3.7%) | 0/787 (0%) |
| MAST MMPR - Escalating Dose Arm | 36/774 (4.7%) | 36/774 (4.7%) | 0/774 (0%) |
| Event | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm |
|---|---|---|
| DeathGeneral disorders | 29/787 | 36/774 |
| Age, Continuous(years) | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm | Total |
|---|---|---|---|
| Median | 44 (29 to 63) | 45 (28 to 62) | 45 (28 to 62) |
| Sex: Female, Male(Participants) | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm | Total |
|---|---|---|---|
| Female | 248 | 252 | 500 |
| Male | 539 | 522 | 1061 |
| Race/Ethnicity, Customized(Participants) | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm | Total |
|---|---|---|---|
| Black | 140 | 167 | 307 |
| Hispanic | 264 | 223 | 487 |
| Other | 20 | 21 | 41 |
| White | 363 | 363 | 726 |
| Region of Enrollment(Participants) | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm | Total |
|---|---|---|---|
| United States | 787 | 774 | 1561 |
| Number of Participants with Prior Opioid Use(Participants) | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm | Total |
|---|---|---|---|
| No | 690 | 685 | 1375 |
| Yes | 65 | 52 | 117 |
| Unknown | 32 | 37 | 69 |
| Number of Participants with a History of Smoking(Participants) | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm | Total |
|---|---|---|---|
| No | 520 | 524 | 1044 |
| Yes | 243 | 217 | 460 |
| Unknown | 24 | 33 | 57 |
| Number of Participants with a Positive Alcohol Screen(Participants) | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm | Total |
|---|---|---|---|
| No | 459 | 474 | 933 |
| Yes | 118 | 130 | 248 |
| Not performed | 210 | 170 | 380 |
| Number of Participants with a Positive Drug Screen(Participants) | Original MMPR - Descending Dose Arm | MAST MMPR - Escalating Dose Arm | Total |
|---|---|---|---|
| No | 319 | 316 | 635 |
| Yes | 175 | 202 | 377 |
| Not performed | 293 | 256 | 549 |
15 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Acetaminophen · Celecoxib · Tramadol · Pregabalin
The University of Texas Health Science Center, Houston →