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The purpose of this study is to determine if intravenous acetaminophen is superior to oral acetaminophen when used as part of a multimodal pathway for primary total hip arthroplasty.
This is a single center, prospective, randomized controlled study. 60 subjects will be recruited (see #6 Recruitment and Compensation below). On the day of surgery, subjects will be randomized to receive either the study intervention (intravenous acetaminophen and placebo tablets) or the control intervention (intravenous saline and active acetaminophen tablets). The Investigational Drug Service will prepare each intervention package, which will include one intravenous and one oral medication dose. Only one of these routes will be active (determined by randomization). Subjects will receive doses of both an intravenous and oral study drug every 6 hours in order to maintain blinding, and will receive a total of 4 doses of each (at 0, 6, 12 and 18 hours). The dose of acetaminophen in all cases will be 1000 mg. The volume of intravenous acetaminophen (and saline) will be 100 mL. The oral dose will consist of two (2) tablets of 500 mg each (or two matching placebo tablets).
All subjects will receive a standardized anesthetic regimen for total hip arthroplasty, as follows:
A) Preoperative phase
Subjects will receive the following preoperative multimodal drugs:
B) Intraoperative phase All subjects will be receive propofol infusion beginning at 50 mg/kg/min and titrated to a Richmond Agitation-Sedation Scale score of -1 to -3 (drowsy to moderate sedation). Dexamethasone 10 mg IV and ketamine 0.25 mg/kg IV up to 40 mg total will be administered as part of the standard multimodal regimen. If required, subjects may receive fentanyl 25 mcg IV as needed to treat discomfort. No joint infiltration will be performed by the surgeon.
C) Postoperative phase In the Post-Anesthesia Care Unit (PACU), subjects will have an intravenous patient-controlled analgesia (IVPCA) device connected and loading doses of hydromorphone administered by the PACU nurse as necessary (0.2 mg q 8 min prn).
On the floor, subjects will receive:
The remaining 3 intervention packages (IV and PO) will be administered at 6, 12 and 18 hours following the first dose. At time point 24 hours (i.e. the fifth dose of acetaminophen), all subjects will begin to receive 975 mg of oral acetaminophen, continuing every six hours until discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous acetaminophen | Experimental | Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo. |
|
| Oral acetaminophen | Active Comparator | Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous acetaminophen | Drug | Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Opioid Consumption | Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption (Other) | morphine equivalent units of intravenous and oral opioids | 0-48 hours |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Time to both discharge readiness and to actual discharge | 0-72 hours |
| Overall Hospital Admission Costs | difference in total hospital admission cost between groups |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Acetaminophen | Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo. Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area. |
| FG001 | Oral Acetaminophen | Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo. Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only completed participants are included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Acetaminophen | Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo. Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 24 Hour Opioid Consumption | Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively | Only completed participants are included. | Posted | Median | Inter-Quartile Range | morphine milliequivalent | 24 hours |
|
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 | Intravenous Acetaminophen | Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo. Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative hematoma | Surgical and medical procedures | Systematic Assessment | Postoperative infected hematoma, admitted to hospital, treated with surgery and antibiotics |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeff Gadsden | Duke University Medical Center | 919-681-6437 | jeff.gadsden@duke.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 | Dec 6, 2017 | Oct 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Oral acetaminophen | Drug | Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area. |
|
| preoperatively |
| Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | 1 hour after arrival to PACU |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | 8 hours |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | 24 hours |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | 36 hours |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | 48 hours |
| Subject Satisfaction at 24 Hours | Overall subject satisfaction with hospital experience at the 24 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. | 24 hours |
| Subject Satisfaction at 48 Hours (48 Hours) | Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. | 48 hours |
| Straight Leg Raise | Number of participants who are able to complete the active straight leg test. The subject rests supine and is asked to lift his/her operative lower limb (with knee extended) until the ankle is 20 cm from level. If the subject can do this, the test is positive. | Postoperative day 1 |
| Heel Slide Test | Number of participants who are able to complete the heel-slide test. The subject rests supine and is asked to place the heel of his/her operative side on the contralateral knee, then slide the heel down to the ankle and back in one continuous motion. If the subject can do this, the test is positive. If the subject cannot do this in one motion, or if pain or other factors prevent the test from being performed, the test is negative. | Postoperative day 1 |
| Number of Participants Able to Complete the Supine to Sit Test | Number of participants able to go from supine to a sitting position independently. | Postoperative day 1 |
| Self-paced Walk Test | Time taken to walk down a hallway 20 m at a safe and quick pace, turn around and return to starting point. | Postoperative day 1 |
| Number of Participants With Opioid-related Adverse Events | Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation | 0-72 hours |
| Analgesic Consumption as Measured by Patient Diary | morphine equivalent units of oral opioids and other non-opioids | day 30 |
| Worst Pain (Day 30) | Participants are asked to rate their WORST pain on POSTOPERATIVE DAY 30 on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | day 30 |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | preoperatively |
| Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) | Pain scores (using NRS-11 scale) at with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | 1 hour after arrival to PACU |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | 8 hours |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | 24 hours |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | 36 hours |
| Subject Satisfaction at 48 Hours | Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. | 48 hours |
| Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | 48 hours |
| 0-72 hours |
| Pharmacy-related Costs | difference in pharmacy-related cost between groups | 0-72 hours |
| Costs Related to Opioid-related Adverse Events | difference in cost related to treatment of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) between groups | 0-72 hours |
| Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events | mean cost (per patient) related to nursing care of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) in $USD | 0-72 hours |
| BG001 |
| Oral Acetaminophen |
Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo. Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ASA Physical Classification | Participants were classified per the American Society of Anesthesiologists (ASA) Physical Class I-III. ASA I = A normal healthy patient; ASA II = A patient with mild systemic disease; ASA III = A patient with severe systemic disease | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.
Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.
|
|
| Secondary | Opioid Consumption (Other) | morphine equivalent units of intravenous and oral opioids | Posted | Median | Inter-Quartile Range | morphine milliequivalent | 0-48 hours |
|
|
|
| Secondary | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | preoperatively |
|
|
|
| Secondary | Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | 1 hour after arrival to PACU |
|
|
|
| Secondary | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | 8 hours |
|
|
|
| Secondary | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours |
|
|
|
| Secondary | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | 36 hours |
|
|
|
| Secondary | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | 48 hours |
|
|
|
| Secondary | Subject Satisfaction at 24 Hours | Overall subject satisfaction with hospital experience at the 24 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. | Only completed participants are included. | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours |
|
|
|
| Secondary | Subject Satisfaction at 48 Hours (48 Hours) | Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. | Only completed participants are included. | Posted | Median | Inter-Quartile Range | score on a scale | 48 hours |
|
|
|
| Secondary | Straight Leg Raise | Number of participants who are able to complete the active straight leg test. The subject rests supine and is asked to lift his/her operative lower limb (with knee extended) until the ankle is 20 cm from level. If the subject can do this, the test is positive. | Only completed participants are included. | Posted | Count of Participants | Participants | Postoperative day 1 |
|
|
|
| Secondary | Heel Slide Test | Number of participants who are able to complete the heel-slide test. The subject rests supine and is asked to place the heel of his/her operative side on the contralateral knee, then slide the heel down to the ankle and back in one continuous motion. If the subject can do this, the test is positive. If the subject cannot do this in one motion, or if pain or other factors prevent the test from being performed, the test is negative. | Only completed participants are included. | Posted | Count of Participants | Participants | Postoperative day 1 |
|
|
|
| Secondary | Number of Participants Able to Complete the Supine to Sit Test | Number of participants able to go from supine to a sitting position independently. | Only completed participants are included. | Posted | Count of Participants | Participants | Postoperative day 1 |
|
|
|
| Secondary | Self-paced Walk Test | Time taken to walk down a hallway 20 m at a safe and quick pace, turn around and return to starting point. | Only completed participants are included. | Posted | Mean | Inter-Quartile Range | seconds | Postoperative day 1 |
|
|
|
| Secondary | Number of Participants With Opioid-related Adverse Events | Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation | Only completed participants are included. | Posted | Number | participants | 0-72 hours |
|
|
|
| Secondary | Analgesic Consumption as Measured by Patient Diary | morphine equivalent units of oral opioids and other non-opioids | Posted | Median | Inter-Quartile Range | mg | day 30 |
|
|
|
| Secondary | Worst Pain (Day 30) | Participants are asked to rate their WORST pain on POSTOPERATIVE DAY 30 on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | day 30 |
|
|
|
| Secondary | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) | Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | preoperatively |
|
|
|
| Secondary | Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) | Pain scores (using NRS-11 scale) at with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | 1 hour after arrival to PACU |
|
|
|
| Secondary | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | 8 hours |
|
|
|
| Secondary | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours |
|
|
|
| Secondary | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | 36 hours |
|
|
|
| Secondary | Subject Satisfaction at 48 Hours | Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. | Only completed participants are included. | Posted | Median | Inter-Quartile Range | score on a scale | 48 hours |
|
|
|
| Secondary | Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) | Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). | Posted | Median | Inter-Quartile Range | score on a scale | 48 hours |
|
|
|
| Other Pre-specified | Hospital Length of Stay | Time to both discharge readiness and to actual discharge | Only completed participants are included. | Posted | Median | Inter-Quartile Range | days | 0-72 hours |
|
|
|
| Other Pre-specified | Overall Hospital Admission Costs | difference in total hospital admission cost between groups | Posted | Median | Inter-Quartile Range | US dollars | 0-72 hours |
|
|
|
| Other Pre-specified | Pharmacy-related Costs | difference in pharmacy-related cost between groups | Posted | Median | Inter-Quartile Range | US dollars | 0-72 hours |
|
|
|
| Other Pre-specified | Costs Related to Opioid-related Adverse Events | difference in cost related to treatment of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) between groups | Posted | Mean | Standard Deviation | US dollars | 0-72 hours |
|
|
|
| Other Pre-specified | Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events | mean cost (per patient) related to nursing care of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) in $USD | Posted | Mean | Standard Deviation | US dollars | 0-72 hours |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 13 |
| 31 |
| EG001 | Oral Acetaminophen | Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo. Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area. | 0 | 29 | 1 | 29 | 13 | 29 |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| wound erythema/drainage | Infections and infestations | Systematic Assessment |
|
| Dizziness/orthostasis | Cardiac disorders | Systematic Assessment |
|
| Hip dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Abnormal lab values (INR) | Investigations | Systematic Assessment |
|
| Polyneuropathy, peripheral | Nervous system disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
Not provided
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| Aniline Compounds |
| D000588 | Amines |