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| Name | Class |
|---|---|
| Cadence Pharmaceuticals | INDUSTRY |
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This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetaminophen will be blinded to the group in which patients are assigned.
The following general perioperative data will be recorded: patient information/preoperative data, procedural information, postoperative information, and overall satisfaction of pain management at 24 hours after surgery.
Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require no opioids in the first 24 hour postoperative period. With the use of intravenous acetaminophen, it is hypothesized that the number of patients that do not require opioids in the first 24 hours after surgery will double.
This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetaminophen will be blinded to the group in which patients are assigned.
The following information will be recorded for each patient enrolled in this study:
Patient information/Preoperative Data
Procedural information
Postoperative Information
Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require no opioids in the first 24 hour postoperative period. With the use of intravenous acetaminophen, it is hypothesized that the number of patients that do not require opioids in the first 24 hours after surgery will double.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Experimental | Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure. |
|
| Placebo | Other | Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Requirement After Surgery | The purpose of the study was to determine whether more patients undergoing craniotomies would not require any opioids (i.e., opioid consumption reduced to zero) during the first 24 postoperative hours when receiving intravenous (IV) acetaminophen during that time compared to those receiving placebo (normal saline). | during first 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Rescue Medication in Both Groups | Time (minutes) from end of procedure to first rescue dose in either PACU or ICU | 0 to 24 hours after surgery |
| Amount of Rescue Medication in PACU in Both Groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Greenberg, MD | NorthShore University Health Sytem - Evanston Hospital Department of Anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
Data is stored in file at our system
anytime
anytime
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen | Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure. Acetaminophen |
| FG001 | Placebo | Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen | Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure. Acetaminophen |
| BG001 | Placebo | Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Requirement After Surgery | The purpose of the study was to determine whether more patients undergoing craniotomies would not require any opioids (i.e., opioid consumption reduced to zero) during the first 24 postoperative hours when receiving intravenous (IV) acetaminophen during that time compared to those receiving placebo (normal saline). | Posted | Count of Participants | Participants | during first 24 hours after surgery |
|
Any adverse events were noted for 7 days following completion of the procedure.
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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 | Acetaminophen | Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure. Acetaminophen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Greenberg | Northshore University Healthsystem, Evanston Hospital | 8475702760 | sbgreenb@gmail.com |
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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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| Drug |
|
|
| 0 to 24 hours after surgery |
| Median Difference in ICU Length of Stay/Hospital Length of Stay Between Both Groups | from 0 to estimated 24 hours after surgery |
| Number of Participants Who Had a Successful Neurologic Exams Between Intervention and Placebo Group as Determined by a Neurosurgical Provider by Answering Either Yes or No | Successful neurologic exams are performed by neurosurgical team during the first 24 hour period. Successful neurologic exams will be provided by a neurosurgical professional and they will answer Yes or No if the exam is appropriate. | from 0 to estimated maximum of 24 hours after surgery |
| Median Difference in Temperature Between Intervention and Placebo Groups | Temperature measure in degrees celcius during the first 24hours postoperatively in increments of 8 hours. | from 0 to estimated maximum 24 hours after surgery |
| Sedation Scores Measured by Richmand-Agitation-Sedation Scale (RASS) Every 8 Hours for 24 Hours in Both Groups | Sedation scores will be evaluated by providers through the Richmand-Agitation-Sedation Scale (RASS) system every 8 hours for the first 24hour postoperatively. The RASS is a 10 point scale with four levels for anxiety or agitation (+1 to +4 (indicates more agitation and alertness the higher number you have)), one level to indicate a calm and alert state (0), and 5 levels of deeper sedation (-1 to -5 ( the more negative number indicating a deeper level of sedation)) patients. It helps guide sedation therapy at the bedside. There are no worse outcomes with different levels of sedation scores. However, typically, we try to keep the scores in the range of 0-+1 to be able to appropriately assess patients and allow them to be mobile in a safe fashion. | during first 24 hours after surgery |
| Pain VAS Scores (1-100) Every 8 Hours for 24 Hours in Both Groups | Pain was measured using the Visual Analog Scale (VAS) for each patient at the time of arrival and every eight hours after arrival for the first 24 hours of ICU stay. A VAS score of 1 indicates little or no pain and a VAS score of 100 indicates severe pain. | during first 24 hours after surgery |
| # of Participants With Delirium Measured by a Positive CAM-ICU Every 8 Hours for 24 Hours in Both Groups- | Delirium was assessed in each of the participants upon arrival to the ICU using the Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU was performed for each participant every 8 hours following admission for the first 24 hours The CAM ICU scoring is based on a scale of 0-7, 0-2=no delirium, 3-5=miild delirium, 6-7=severe delirium. The positive CAM ICU consists of features 1 and 2 and either 3 or 4: Features 1: Acute onset or fluctuating course Features 2: Inattention Features 3: Disorganized thinking Features 4: Altered level of consciousness | during first 24 hours after surgery |
| Median Satisfaction Scores on a Verbal Score From 1(Not Satisfied at All) to 100 (Very Satisfied) | on a verbal score 1-100, 1 would mean that the patient is not satisfied at all and 100 would mean that the patient was very satisfied. | During first 24 hours after surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to Rescue Medication in Both Groups | Time (minutes) from end of procedure to first rescue dose in either PACU or ICU | Posted | Median | Inter-Quartile Range | minutes | 0 to 24 hours after surgery |
|
|
|
| Secondary | Amount of Rescue Medication in PACU in Both Groups | Posted | Median | Inter-Quartile Range | mg | 0 to 24 hours after surgery |
|
|
|
| Secondary | Median Difference in ICU Length of Stay/Hospital Length of Stay Between Both Groups | Posted | Median | Inter-Quartile Range | hours | from 0 to estimated 24 hours after surgery |
|
|
|
| Secondary | Number of Participants Who Had a Successful Neurologic Exams Between Intervention and Placebo Group as Determined by a Neurosurgical Provider by Answering Either Yes or No | Successful neurologic exams are performed by neurosurgical team during the first 24 hour period. Successful neurologic exams will be provided by a neurosurgical professional and they will answer Yes or No if the exam is appropriate. | As length of stay increased in ICU, the likelihood of discharge increased for the patients. This lowered the total amount of analyzed patients as the time increased. | Posted | Count of Participants | Participants | from 0 to estimated maximum of 24 hours after surgery |
|
|
|
| Secondary | Median Difference in Temperature Between Intervention and Placebo Groups | Temperature measure in degrees celcius during the first 24hours postoperatively in increments of 8 hours. | Posted | Median | Inter-Quartile Range | Degrees Celcius | from 0 to estimated maximum 24 hours after surgery |
|
|
|
| Secondary | Sedation Scores Measured by Richmand-Agitation-Sedation Scale (RASS) Every 8 Hours for 24 Hours in Both Groups | Sedation scores will be evaluated by providers through the Richmand-Agitation-Sedation Scale (RASS) system every 8 hours for the first 24hour postoperatively. The RASS is a 10 point scale with four levels for anxiety or agitation (+1 to +4 (indicates more agitation and alertness the higher number you have)), one level to indicate a calm and alert state (0), and 5 levels of deeper sedation (-1 to -5 ( the more negative number indicating a deeper level of sedation)) patients. It helps guide sedation therapy at the bedside. There are no worse outcomes with different levels of sedation scores. However, typically, we try to keep the scores in the range of 0-+1 to be able to appropriately assess patients and allow them to be mobile in a safe fashion. | The amount of participants analyzed decreased as length of stay in the ICU increased as patients were likely discharged from the ICU. The median number indicates the RASS score and not the number of participants. | Posted | Median | Inter-Quartile Range | median of RASS scores | during first 24 hours after surgery |
|
|
|
| Secondary | Pain VAS Scores (1-100) Every 8 Hours for 24 Hours in Both Groups | Pain was measured using the Visual Analog Scale (VAS) for each patient at the time of arrival and every eight hours after arrival for the first 24 hours of ICU stay. A VAS score of 1 indicates little or no pain and a VAS score of 100 indicates severe pain. | The median number below indicates the median VAS score. | Posted | Median | Inter-Quartile Range | units on a scale | during first 24 hours after surgery |
|
|
|
| Secondary | # of Participants With Delirium Measured by a Positive CAM-ICU Every 8 Hours for 24 Hours in Both Groups- | Delirium was assessed in each of the participants upon arrival to the ICU using the Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU was performed for each participant every 8 hours following admission for the first 24 hours The CAM ICU scoring is based on a scale of 0-7, 0-2=no delirium, 3-5=miild delirium, 6-7=severe delirium. The positive CAM ICU consists of features 1 and 2 and either 3 or 4: Features 1: Acute onset or fluctuating course Features 2: Inattention Features 3: Disorganized thinking Features 4: Altered level of consciousness | As the time post surgery increased, the amount of individual participants discharged from the ICU increased. | Posted | Count of Participants | Participants | during first 24 hours after surgery |
|
|
|
| Secondary | Median Satisfaction Scores on a Verbal Score From 1(Not Satisfied at All) to 100 (Very Satisfied) | on a verbal score 1-100, 1 would mean that the patient is not satisfied at all and 100 would mean that the patient was very satisfied. | Posted | Median | Inter-Quartile Range | units on a scale | During first 24 hours after surgery |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Placebo | Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure. Placebo | 0 | 65 | 0 | 65 | 0 | 65 |
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| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| 8 Hours |
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| 16 Hours |
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| 24 Hours |
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| 16 Hours |
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| 24 Hours |
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| 8 hours |
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| 16 hours |
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| 24 hours |
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| 16 Hours |
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| 24 Hours |
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| 8 Hours |
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| 16 Hours |
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| 24 Hours |
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