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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.
We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. One group of subjects will receive IV acetaminophen every six hours beginning within 30 minutes before surgical end time and continuing for 24 hours plus IV morphine PCA, and the other group will receive IV placebo every six hours plus IV morphine PCA, a standard treatment for postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline Placebo | Placebo Comparator | Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. |
|
| IV Acetaminophen | Active Comparator | Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Acetaminophen | Drug | 1000mg IV Ofirmev given every six hours for a total of four doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Morphine Consumption (mg) | How much morphine the subject consumes in the first 24 hours after surgery (mg). | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of PCA Requests in First 24 Hours Post-Operation | The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation | 24 hours post-operation |
| VAS Pain Score 2 Hours Post Operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugh Hemmings, MD, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Label information for acetaminophen (ofirmev) | View source |
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There is no plan to share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Saline Placebo | Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm. |
| FG001 | IV Acetaminophen | Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline Placebo | Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm. |
| BG001 | IV Acetaminophen |
| 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 | Total Morphine Consumption (mg) | How much morphine the subject consumes in the first 24 hours after surgery (mg). | Posted | Median | Inter-Quartile Range | mg | 24 hours |
|
24 hour study treatment period
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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 | Saline Placebo | Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inadequate Pain Control | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hugh Hemmings, MD, PhD | Weill Cornell Medicine | 212-746-2953 | hchemmi@med.cornell.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Saline Placebo | Drug | Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm. |
|
|
2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100). |
| 2 Hours Post Operation |
| VAS Pain Score 6 Hours Post-Operation | 6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100). | 6 Hours Post-Operation |
| VAS Score 24 Hours Post-Operation | 24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100). | 24 hours post-operation |
Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Total Number of PCA Requests in First 24 Hours Post-Operation | The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation | Posted | Median | Inter-Quartile Range | PCA requests | 24 hours post-operation |
|
|
|
| Secondary | VAS Pain Score 2 Hours Post Operation | 2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100). | Posted | Median | Inter-Quartile Range | mm | 2 Hours Post Operation |
|
|
|
| Secondary | VAS Pain Score 6 Hours Post-Operation | 6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100). | Posted | Median | Inter-Quartile Range | mm | 6 Hours Post-Operation |
|
|
|
| Secondary | VAS Score 24 Hours Post-Operation | 24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100). | Posted | Median | Inter-Quartile Range | mm | 24 hours post-operation |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | IV Acetaminophen | Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses. | 0 | 8 | 0 | 8 | 4 | 8 |
| Lethargy | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |