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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR000370 | U.S. NIH Grant/Contract | View source | |
| UL1TR000371 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This is a comparative effectiveness study of current pain management strategies in acutely injured trauma patients. Two different multi-modal, opioid minimizing analgesic strategies will be compared [original multimodal pain regimen (MMPR) compared to multi-modal analgesic strategies for trauma (MAST) MMPR].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen IV/PO | Drug | Acetaminophen 1g IV/PO every 6 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | until discharge from hospital or 30 days post admission (whichever is sooner) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | until discharge from hospital or 30 days post admission (whichever is sooner) |
| Pain as Assessed by Score on the Behavioral Pain Scale (BPS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Harvin, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30206549 | Background | 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. | |
| 33486130 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | MME per day | until discharge from hospital or 30 days post admission (whichever is sooner) |
|
From hospital admission to hospital discharge (about 30 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John A. Harvin, MD | The University of Texas Health Science Center at Houston | (713) 500-7244 | John.Harvin@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2018 | May 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D000068579 | Celecoxib |
| D009288 | Naproxen |
| D014147 | Tramadol |
| D000069583 | Pregabalin |
| D000077206 | Gabapentin |
| D008012 | Lidocaine |
| D000701 | Analgesics, Opioid |
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Acetaminophen PO |
| Drug |
Acetaminophen 1g PO every 6 hours |
|
| Ketorolac | Drug | Ketorolac 30mg IV once |
|
| Celebrex | Drug | Celebrex 200mg PO every 12 hours |
|
| Naproxen | Drug | Naproxen 500mg PO every 12 hours |
|
| Tramadol | Drug | Tramadol 100mg PO every 6 hours |
|
| Pregabalin | Drug | Pregabalin 100mg PO every 8 hours |
|
| Gabapentin | Drug | Gabapentin 300mg PO every 8 hours |
|
| Lidocaine | Drug | Lidocaine patch every 12 hours |
|
| Opioids | Drug | Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl) |
|
| Regional anesthesia | Drug | Regional anesthesia |
|
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. |
| until discharge from hospital or 30 days post admission (whichever is sooner) |
| Number of Participants Discharged From the Hospital With an Opioid Prescription | 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. | 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. | 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. | 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." | 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." | 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." | 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. | 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 | until discharge from hospital or 30 days post admission (whichever is sooner) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of Participants with Prior Opioid Use | Count of Participants | Participants |
|
| Number of Participants with a History of Smoking | Count of Participants | Participants |
|
| Number of Participants with a Positive Alcohol Screen | Count of Participants | Participants |
|
| Number of Participants with a Positive Drug Screen | Count of Participants | Participants |
|
| Score on Abbreviated Injury Scale (AIS) - Head | The AIS classifies individual injuries by body region as follows: 0 = No Injury; 1 = Minor; 2 = Moderate; 3 = Serious; 4 = Severe; 5 = Critical; 6 = Maximal (currently untreatable) | Median | Inter-Quartile Range | units on a scale |
|
| Score on Abbreviated Injury Scale (AIS) - Chest | The AIS classifies individual injuries by body region as follows: 0 = No Injury; 1 = Minor; 2 = Moderate; 3 = Serious; 4 = Severe; 5 = Critical; 6 = Maximal (currently untreatable) | Median | Inter-Quartile Range | units on a scale |
|
| Score on Abbreviated Injury Scale (AIS) - Abdomen | The AIS classifies individual injuries by body region as follows: 0 = No Injury; 1 = Minor; 2 = Moderate; 3 = Serious; 4 = Severe; 5 = Critical; 6 = Maximal (currently untreatable) | Median | Inter-Quartile Range | units on a scale |
|
| Injury Severity Score (ISS) | The Injury Severity Score (ISS) assesses the combined effects of injuries in multiple anatomical locations and ranges from from 1 to 75, with 75 being the most severe. | Median | Inter-Quartile Range | units on a scale |
|
| Number of participants with rib fractures | Count of Participants | Participants |
|
| Number of rib fractures | Median | Inter-Quartile Range | rib fractures |
|
| Number of participants with flail segment | Flail segment is the condition of having three or more contiguous ribs fractured in two or more places | Count of Participants | Participants |
|
| Number of participants with long bone fracture | Count of Participants | Participants |
|
| Number of participants with vertebral body fracture | Count of Participants | Participants |
|
| Number of participants with pelvis or acetabulum fracture | Count of Participants | Participants |
|
| Number of participants with traumatic brain injury | Count of Participants | Participants |
|
| Unit of admission | Count of Participants | Participants |
|
| Number of participants who underwent laparotomy procedure | Count of Participants | Participants |
|
| Number of participants who underwent thoracotomy procedure | Count of Participants | Participants |
|
| Number of participants who underwent amputation procedure | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | 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. | This data was only collected from 739 in the Original MMPR arm and 735 in the MAST MMPR arm. | Posted | Median | Inter-Quartile Range | units on a scale | until discharge from hospital or 30 days post admission (whichever is sooner) |
|
|
|
| Secondary | 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. | This data was only collected from 156 in the Original MMPR arm and 150 in the MAST MMPR arm. | Posted | Median | Inter-Quartile Range | score on a scale | until discharge from hospital or 30 days post admission (whichever is sooner) |
|
|
|
| Secondary | Number of Participants Discharged From the Hospital With an Opioid Prescription | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | until discharge from hospital or 30 days post admission (whichever is sooner) |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | dollars | until discharge from hospital or 30 days post admission (whichever is sooner) |
|
|
|
| Secondary | Pharmacy Costs | The costs of the pain medications given during the specified time period. | Posted | Median | Inter-Quartile Range | dollars | until discharge from hospital or 30 days post admission (whichever is sooner) |
|
|
|
| Secondary | 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." | Posted | Mean | 95% Confidence Interval | ventilator days | 30 days |
|
|
|
| Secondary | 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." | Posted | Mean | 95% Confidence Interval | hospital days | 30 days |
|
|
|
| Secondary | 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." | Posted | Mean | 95% Confidence Interval | ICU days | 30 days |
|
|
|
| Secondary | 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. | These data were not collected. | Posted | until discharge from hospital or 30 days post admission (whichever is sooner) |
|
|
| Secondary | Degree to Which Function is Limited by Pain as Indicated by Number of Participants Who Failed to Work With Physical Therapist Due to Pain | These data were not collected. | Posted | until discharge from hospital or 30 days post admission (whichever is sooner) |
|
|
| 29 |
| 787 |
| 29 |
| 787 |
| 0 |
| 787 |
| EG001 | 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. | 36 | 774 | 36 | 774 | 0 | 774 |
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| D006571 | Heterocyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| Cardiac arrest with Cardiopulmonary resuscitation (CPR) |
|
| Ileus |
|
| Naloxone reversal |
|