Not provided
Not provided
Not provided
Not provided
Not provided
The study was halted due to the worldwide COVID-19 pandemic and the cancellation of all elective cases.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Study Objective The aim of the proposed study is to examine the effect of Q4 hour multidose IV acetaminophen on patients' readiness for discharge. In doing so the investigators will also investigate the various factors that could potentially contribute to a patient's readiness for discharge such as overall opioid consumption, time to rescue medication, incidence of postoperative nausea and vomiting, pain scores, and perioperative stress markers and their overall correlation with IV acetaminophen intake.
This is a randomized, double-blind, placebo-controlled, two-arm parallel study.. Patients 50kg or more will receive either 1000mg IV acetaminophen or placebo with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours.
After pre-oxygenation, general anesthesia will be induced with lidocaine (1 mg/kg Ideal Body Weight), propofol (1-2 mg/kg Actual Body Weight), and fentanyl (up to 5 mcg/kg Actual Body Weight). Additionally all subjects with receive 2 mg midazolam. Tracheal intubation will be facilitated with rocuronium (0.6 - 1.2 mg/kg Actual Body Weight). Anesthesia will be maintained with air/oxygen (60%/40%) and desflurane. A remifentanyl infusion (0.05-2mcg/kg/min Ideal Body Weight) will be continued throughout the entire case with no further analgesics being administered. All patients will receive ondansetron 4 mg prior to the end of operation as well as additional antiemetics in the PACU as judged by the attending anesthesiologist. Patients will be awakened and extubated in the OR meeting standard extubation criteria. Once extubated all patients will then be transferred to the PACU where they will be assessed via the SPEEDs criteria 5 minutes after arrival and then every 15 minutes for the duration of their PACU stay. While in the PACU, all patients will be assessed for pain using the Visual Analog Scale. Pain will be treated as per our protocol with 0.2mg IV hydromorphone for mild pain (VAS 1-3), 0.4 mg IV hydromorphone for moderate pain (VAS 4-6), and 0.6 mg IV hydromorphone (VAS 7-10). As soon as a patient meets all the SPEEDs criteria he/she will be transferred to phase II of the recovery. In phase II, if need be, pain will be managed according to the following orders: 0.2mg intravenous hydromorphone for mild pain (VAS 1-3), 0.4 mg intravenous hydromorphone for moderate pain (VAS 4-6) and 0.6mg intravenous hydromorphone for severe pain (VAS 7-10).
The patient's readiness for discharge will be our primary outcome. Each patient will be assessed within 5 minutes of arriving in the PACU and then every 15 minutes thereafter until subject reaches maximum score. The assessment will be done using the SPEEDs criteria, which has recently been shown to be as specific and more sensitive for phase 1 nursing interventions and therefore more accurate in predicting which patients are fast-track eligible as compared to the standard Modified Aldrete 2 and Fast-Track criteria (38).
The secondary outcomes will include:
a. This will focus on three of the following factors rated on a scale of 1 to 5, with 1 being dissatisfied/unlikely while 5 being most satisfied/very likely.
i. How satisfied are you with the overall experience? ii. How likely are you to recommend this anesthetic and analgesic to others? iii. How likely would you ask for a similar anesthetic and analgesic in the future if need be? f) Concentration of the plasma stress markers including cortisol, norepinephrine, epinephrine, and C Reactive Protein (CRP).
a. Changes in mediator levels in the IV acetaminophen versus placebo groups will be compared. Plasma samples will be collected before administration of any drug (after placement of IV lines), before incision, and 60 minutes after arrival in PACU. Blood [15millLiters] will be collected at the time points described above from an additional intravenous catheter placed in the patient's arm. These specimens will be placed in vacutainer tubes with no anti-coagulant. Blood will be drawn with a syringe attached directly to the angiocatheter which has been placed intravenously. To prevent hemolysis, blood will be transferred without a needle, to a vacutainer whose top has been removed. The vacutainer top will be replaced and specimens labeled with study name, subject's study IDentification number, sample number (1, 2, 3,), and dated. Bloods from the first two time points will be kept refrigerated until the final sample is obtained postoperatively. They will be centrifuged, serum removed, aliquoted and stored at -80 degrees C until analysis. All samples will be run in duplicate on with plates and reagents of the same lot. Any samples varying greater than 15% between duplicates
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal saline | Active Comparator | Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist. |
|
| acetaminophen | Experimental | Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Readiness for Discharge | Number (percentage) of Participants with Readiness for Discharge (achieving discharge-readiness status at end of 2- hours post-surgery evaluated using the SPEEDs criteria: oxygen saturation, pain control, emesis control, extremity movement, dialogue, and stable vital signs. | 2 hours following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Pain Scores | Pain scores every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour. Visual Analogue Scale (VAS) for pain was used: score on a scale from 0 (no pain) to 10 (worst pain) were recorded. | Every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour |
Not provided
Inclusion Criteria:
Exclusion Criteria -
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michal Gajewski, Do | Rutgers, State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey Medical School | Newark | New Jersey | 07103 | United States | ||
| University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
At the time when recruitment reached 88 subject, elective surgeries at our institution were paused because of pandemic. However, when elective surgeries were resumed, Mallinckrodt, Inc. who provided support for the study filed for bankruptcy and we were not longer able to continue recruitment.
Planned enrollment was "90" whereas the actual enrollment was "88".
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist. normal saline: 100mL of normal saline every 4 hours to a maximum administration of 400mL |
| FG001 | Acetaminophen | Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline Acetaminophen: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 88 patients were enrolled; from 47 who were randomized to receive intravenous acetaminophen 45 completed the study; from 41 received placebo 41 completed. A total of 65 patients were included into analyses with 34 receiving intravenous acetaminophen and 31 receiving placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist. normal saline: 100mL of normal saline every 4 hours to a maximum administration of 400mL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median (q1, q3) |
| 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 | Readiness for Discharge | Number (percentage) of Participants with Readiness for Discharge (achieving discharge-readiness status at end of 2- hours post-surgery evaluated using the SPEEDs criteria: oxygen saturation, pain control, emesis control, extremity movement, dialogue, and stable vital signs. | Posted | Count of Participants | Participants | 2 hours following surgery |
|
From the time patient sign Informed Consent Form for 24 hours or until discharge from the hospital, whatever comes first, an average of 12 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline | Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist. normal saline: 100mL of normal saline every 4 hours to a maximum administration of 400mL |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical complication | Surgical and medical procedures | Systematic Assessment | Surgical complication not related to study medication |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michal Gajewski, DO | CHRISTUS St. Vincent Regional Medical Center | (505) 913-3361 | Michal.Gajewski@stvin.org |
Not provided
| 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 | Nov 11, 2020 | Aug 30, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2019 | Oct 16, 2020 | ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| normal saline | Drug | 100mL of normal saline every 4 hours to a maximum administration of 400mL |
|
|
| Plasma Stress Markers | Concentration of the plasma stress markers including epinephrine, norepinephrine, cortisol, interleukins (IL) 6, 8 and 10. | Before administration of any drug (after placement of intravenous (IV) line), before surgical incision (in operating room (OR)), and 1 h after arrival in post-anesthesia care unit (PACU) |
| The Level of C-reactive Protein | Concentration of the plasma C-reactive protein (CRP) | Before administration of any drug (after placement of intravenous (IV) line), before surgical incision (in operating room (OR)), and 1 h after arrival in post-anesthesia care unit (PACU) |
| Time to Rescue Pain Medication | Time to the first dose of pain medication | From arrival in PACU to the first dose of pain medication is given during 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour. |
| Total Dosage of Post Operative Opioids | Total dosage of post operative opioids (hydromorphone) | From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour. |
| Patient Satisfaction Survey | Survey asking patients about their satisfaction with the experience, pain control, and anesthetic rated on a 5 point Likert scale, with 1 being dissatisfied/unlikely and 5 being most satisfied/very likely. Subscales were summed to receive total score. | For patients going home the day of surgery the survey is given prior to departing the hospital (approx 5 hours post surgery). For those being admitted, the survey is given once discharge criteria are met in the PACU (approx 3 hours post surgery). |
| Number of Participants With Post Operative Nausea and Vomiting | Number of Participants with Post Operative Nausea and Vomiting | From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour |
| Number of Participants Requiring Additional Anti-emetics | Number of Participants Requiring Additional Anti-emetics (anti-vomiting) | From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour |
| Newark |
| New Jersey |
| 07103 |
| United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| BG001 | Acetaminophen | Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline Acetaminophen: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours. |
| BG002 | Total | Total of all reporting groups |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ASA Physical Status | Count of Participants | Participants |
|
Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline Acetaminophen: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours. |
|
|
| Secondary | Post Operative Pain Scores | Pain scores every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour. Visual Analogue Scale (VAS) for pain was used: score on a scale from 0 (no pain) to 10 (worst pain) were recorded. | Not all participants were analyzed at every time point up to 120 minutes but only until participants were achieving discharge-readiness criteria. | Posted | Median | Inter-Quartile Range | score on a scale from 0 to 10 | Every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour |
|
|
|
| Secondary | Plasma Stress Markers | Concentration of the plasma stress markers including epinephrine, norepinephrine, cortisol, interleukins (IL) 6, 8 and 10. | Posted | Median | Inter-Quartile Range | pg/ml | Before administration of any drug (after placement of intravenous (IV) line), before surgical incision (in operating room (OR)), and 1 h after arrival in post-anesthesia care unit (PACU) |
|
|
|
| Secondary | The Level of C-reactive Protein | Concentration of the plasma C-reactive protein (CRP) | Posted | Median | Inter-Quartile Range | pg/ml *1000 | Before administration of any drug (after placement of intravenous (IV) line), before surgical incision (in operating room (OR)), and 1 h after arrival in post-anesthesia care unit (PACU) |
|
|
|
| Secondary | Time to Rescue Pain Medication | Time to the first dose of pain medication | Posted | Median | Inter-Quartile Range | minutes | From arrival in PACU to the first dose of pain medication is given during 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour. |
|
|
|
| Secondary | Total Dosage of Post Operative Opioids | Total dosage of post operative opioids (hydromorphone) | Posted | Median | Inter-Quartile Range | mg | From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour. |
|
|
|
| Secondary | Patient Satisfaction Survey | Survey asking patients about their satisfaction with the experience, pain control, and anesthetic rated on a 5 point Likert scale, with 1 being dissatisfied/unlikely and 5 being most satisfied/very likely. Subscales were summed to receive total score. | Posted | Median | Inter-Quartile Range | score on a scale | For patients going home the day of surgery the survey is given prior to departing the hospital (approx 5 hours post surgery). For those being admitted, the survey is given once discharge criteria are met in the PACU (approx 3 hours post surgery). |
|
|
|
| Secondary | Number of Participants With Post Operative Nausea and Vomiting | Number of Participants with Post Operative Nausea and Vomiting | Posted | Count of Participants | Participants | From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour |
|
|
|
| Secondary | Number of Participants Requiring Additional Anti-emetics | Number of Participants Requiring Additional Anti-emetics (anti-vomiting) | Posted | Count of Participants | Participants | From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Acetaminophen | Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline Acetaminophen: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours. | 0 | 47 | 0 | 47 | 2 | 47 |
|
Not provided
Not provided
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| 30 minutes |
|
|
| 45 minutes |
|
|
| 60 minutes |
|
|
| 75 minutes |
|
|
| 90 minutes |
|
|
| 105 minutes |
|
|
| 120 minutes |
|
|
| Epinephrine 1h in PACU |
|
| Norepinephrine After IV |
|
| Norepinephrine In OR |
|
| Norepinephrine 1h in PACU |
|
| Cortisol After IV |
|
| Cortisol in OR |
|
| Cortisol 1h in PACU |
|
| IL-6 after IV |
|
| IL-6 in OR |
|
| IL-6 1h in PACU |
|
| IL-8 after IV |
|
| IL-8 in OR |
|
| IL-8 1h in PACU |
|
| IL-10 after IV |
|
| IL-10 in OR |
|
| IL-10 1h in PACU |
|
| CRP 1h in PACU |
|