Multi-dose Acetaminophen for Patients Undergoing General Anesthesia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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:
-
Post-operative pain scores a. Assessed every 15 minutes during the recovery period using the Visual and Numerical Analog Scales for 2 hours and then every 4 hours thereafter until discharge.
-
Time to first rescue medication a. 0.2mg intravenous hydromorphone for mild pain (VAS 1-3) b. 0.4mg intravenous hydromorphone for moderate pain (VAS 4-6) c. 0.6 mg intravenous hydromorphone for severe pain (VAS 7-10)
-
Total dosage of post-operative opioids given.
-
Incidence of post operative nausea and vomiting and need for additional antiemetics.
-
Phase II satisfaction survey:
-
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.
-
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).
-
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Drug: normal saline
100mL of normal saline every 4 hours to a maximum administration of 400mL
Other Names:
|
| Experimental: 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 |
Drug: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Readiness for Discharge [2 hours following surgery]
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.
Secondary Outcome Measures
- Post Operative Pain Scores [Every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour]
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.
- Plasma Stress Markers [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)]
Concentration of the plasma stress markers including epinephrine, norepinephrine, cortisol, interleukins (IL) 6, 8 and 10.
- The Level of C-reactive Protein [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)]
Concentration of the plasma C-reactive protein (CRP)
- Time to Rescue 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.]
Time to the first dose of pain medication
- Total Dosage of Post Operative Opioids [From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour.]
Total dosage of post operative opioids (hydromorphone)
- Patient Satisfaction Survey [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).]
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.
- 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 with Post Operative Nausea and Vomiting
- Number of Participants Requiring Additional Anti-emetics [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 (anti-vomiting)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Undergoing ambulatory laparoscopic cholecystectomy.
-
American Society of Anesthesiologists physical status 1, 2 or 3.-
Exclusion Criteria -
-
Cognitively impaired (by history) and unable or unwilling to consent
-
Chronic steroid or opioid user (as prescribed for a chronic systemic illness)
-
Parturient or nursing mother. Patients who have been informed by a physician that they have liver or kidney disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New Jersey Medical School | Newark | New Jersey | United States | 07103 |
| 2 | University Hospital | Newark | New Jersey | United States | 07103 |
| 3 | New York Methodist Hospital | Brooklyn | New York | United States | 11215 |
Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- Mallinckrodt
Investigators
- Principal Investigator: Michal Gajewski, Do, Rutgers, State University of New Jersey
Study Documents (Full-Text)
More Information
Publications
None provided.- 20150002613
Study Results
Participant Flow
| Recruitment Details | Planned enrollment was "90" whereas the actual enrollment was "88". |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Normal Saline | Acetaminophen |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Period Title: Overall Study | ||
| STARTED | 41 | 47 |
| Participants Who Were Included in the Analysis | 31 | 34 |
| COMPLETED | 41 | 45 |
| NOT COMPLETED | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Normal Saline | Acetaminophen | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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. | Total of all reporting groups |
| Overall Participants | 31 | 34 | 65 |
| Age (years) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [years] |
40
|
44
|
42
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
26
83.9%
|
25
73.5%
|
51
78.5%
|
| Male |
5
16.1%
|
9
26.5%
|
14
21.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Black |
5
16.1%
|
11
32.4%
|
16
24.6%
|
| White |
3
9.7%
|
4
11.8%
|
7
10.8%
|
| Hispanic |
23
74.2%
|
19
55.9%
|
42
64.6%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
31
100%
|
34
100%
|
65
100%
|
| ASA Physical Status (Count of Participants) | |||
| The American Society of Anesthesiologists (ASA) Physical Status I (Patient is healthy) |
12
38.7%
|
6
17.6%
|
18
27.7%
|
| ASA Physical Status II (Patient has mild systemic disease) |
18
58.1%
|
26
76.5%
|
44
67.7%
|
| ASA Physical Status III (Patient has severe systemic disease that is not incapacitating) |
1
3.2%
|
2
5.9%
|
3
4.6%
|
Outcome Measures
| Title | Readiness for Discharge |
|---|---|
| Description | 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. |
| Time Frame | 2 hours following surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Normal Saline | Acetaminophen |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 31 | 34 |
| Count of Participants [Participants] |
26
83.9%
|
33
97.1%
|
| Title | Post Operative Pain Scores |
|---|---|
| Description | 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. |
| Time Frame | Every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not all participants were analyzed at every time point up to 120 minutes but only until participants were achieving discharge-readiness criteria. |
| Arm/Group Title | Normal Saline | Acetaminophen |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 31 | 34 |
| 15 minutes |
9
|
7
|
| 30 minutes |
8
|
7
|
| 45 minutes |
7
|
6
|
| 60 minutes |
5
|
4
|
| 75 minutes |
5
|
4
|
| 90 minutes |
5
|
3
|
| 105 minutes |
5
|
3
|
| 120 minutes |
6.5
|
3
|
| Title | Plasma Stress Markers |
|---|---|
| Description | Concentration of the plasma stress markers including epinephrine, norepinephrine, cortisol, interleukins (IL) 6, 8 and 10. |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Normal Saline | Acetaminophen |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 31 | 34 |
| Epinephrine After IV |
48
|
65
|
| Epinephrine In OR |
42
|
58
|
| Epinephrine 1h in PACU |
152
|
128
|
| Norepinephrine After IV |
643
|
644
|
| Norepinephrine In OR |
532
|
547
|
| Norepinephrine 1h in PACU |
689
|
884
|
| Cortisol After IV |
50.5
|
54.6
|
| Cortisol in OR |
45.6
|
49
|
| Cortisol 1h in PACU |
175.9
|
150.1
|
| IL-6 after IV |
1.4
|
2.3
|
| IL-6 in OR |
1.6
|
2
|
| IL-6 1h in PACU |
7.9
|
9.9
|
| IL-8 after IV |
8.7
|
8.3
|
| IL-8 in OR |
6.6
|
6.4
|
| IL-8 1h in PACU |
13.7
|
12.5
|
| IL-10 after IV |
0.6
|
1
|
| IL-10 in OR |
0.5
|
1.9
|
| IL-10 1h in PACU |
1.9
|
1.9
|
| Title | The Level of C-reactive Protein |
|---|---|
| Description | Concentration of the plasma C-reactive protein (CRP) |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Normal Saline | Acetaminophen |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 31 | 34 |
| CRP after IV |
1062.6
|
1710.9
|
| CRP in OR |
893.4
|
1410.7
|
| CRP 1h in PACU |
746.6
|
1090.1
|
| Title | Time to Rescue Pain Medication |
|---|---|
| Description | Time to the first dose of pain medication |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Normal Saline | Acetaminophen |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 31 | 34 |
| Median (Inter-Quartile Range) [minutes] |
19
|
23
|
| Title | Total Dosage of Post Operative Opioids |
|---|---|
| Description | Total dosage of post operative opioids (hydromorphone) |
| Time Frame | From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Normal Saline | Acetaminophen |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 31 | 34 |
| Median (Inter-Quartile Range) [mg] |
1.2
|
1
|
| Title | Patient Satisfaction Survey |
|---|---|
| Description | 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. |
| Time Frame | 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Normal Saline | Acetaminophen |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 31 | 34 |
| Median (Inter-Quartile Range) [score on a scale] |
4
|
4
|
| Title | Number of Participants With Post Operative Nausea and Vomiting |
|---|---|
| Description | Number of Participants with Post Operative Nausea and Vomiting |
| Time Frame | From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Normal Saline | Acetaminophen |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 31 | 34 |
| Count of Participants [Participants] |
9
29%
|
10
29.4%
|
| Title | Number of Participants Requiring Additional Anti-emetics |
|---|---|
| Description | Number of Participants Requiring Additional Anti-emetics (anti-vomiting) |
| Time Frame | From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Normal Saline | Acetaminophen |
|---|---|---|
| Arm/Group Description | 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 | 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. |
| Measure Participants | 31 | 34 |
| Count of Participants [Participants] |
8
25.8%
|
7
20.6%
|
Adverse Events
| Time Frame | 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 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Normal Saline | Acetaminophen | ||
| Arm/Group Description | 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 | 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. | ||
All Cause Mortality |
||||
| Normal Saline | Acetaminophen | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/41 (0%) | 0/47 (0%) | ||
Serious Adverse Events |
||||
| Normal Saline | Acetaminophen | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/41 (0%) | 0/47 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Normal Saline | Acetaminophen | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/41 (0%) | 2/47 (4.3%) | ||
| Surgical and medical procedures | ||||
| Surgical complication | 0/41 (0%) | 0 | 2/47 (4.3%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Michal Gajewski, DO |
|---|---|
| Organization | CHRISTUS St. Vincent Regional Medical Center |
| Phone | (505) 913-3361 |
| Michal.Gajewski@stvin.org |
- 20150002613