Trial Outcomes & Findings for Multi-dose Acetaminophen for Patients Undergoing General Anesthesia (NCT NCT02832687)
NCT ID: NCT02832687
Last Updated: 2021-12-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
88 participants
Primary outcome timeframe
2 hours following surgery
Results posted on
2021-12-09
Participant Flow
Planned enrollment was "90" whereas the actual enrollment was "88".
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.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
47
|
|
Overall Study
Participants Who Were Included in the Analysis
|
31
|
34
|
|
Overall Study
COMPLETED
|
41
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
Multi-dose Acetaminophen for Patients Undergoing General Anesthesia
Baseline characteristics by cohort
| Measure |
Normal Saline
n=31 Participants
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
|
Acetaminophen
n=34 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.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
44 years
n=7 Participants
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
ASA Physical Status
The American Society of Anesthesiologists (ASA) Physical Status I (Patient is healthy)
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
ASA Physical Status
ASA Physical Status II (Patient has mild systemic disease)
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
ASA Physical Status
ASA Physical Status III (Patient has severe systemic disease that is not incapacitating)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours following surgeryNumber (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.
Outcome measures
| Measure |
Normal Saline
n=31 Participants
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
|
Acetaminophen
n=34 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.
|
|---|---|---|
|
Readiness for Discharge
|
26 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hourPopulation: Not all participants were analyzed at every time point up to 120 minutes but only until participants were achieving discharge-readiness criteria.
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.
Outcome measures
| Measure |
Normal Saline
n=31 Participants
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
|
Acetaminophen
n=34 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.
|
|---|---|---|
|
Post Operative Pain Scores
15 minutes
|
9 score on a scale from 0 to 10
Interval 7.0 to 10.0
|
7 score on a scale from 0 to 10
Interval 5.0 to 9.0
|
|
Post Operative Pain Scores
30 minutes
|
8 score on a scale from 0 to 10
Interval 6.0 to 10.0
|
7 score on a scale from 0 to 10
Interval 6.0 to 8.0
|
|
Post Operative Pain Scores
45 minutes
|
7 score on a scale from 0 to 10
Interval 5.0 to 8.0
|
6 score on a scale from 0 to 10
Interval 4.0 to 8.0
|
|
Post Operative Pain Scores
60 minutes
|
5 score on a scale from 0 to 10
Interval 3.0 to 7.0
|
4 score on a scale from 0 to 10
Interval 2.0 to 6.0
|
|
Post Operative Pain Scores
75 minutes
|
5 score on a scale from 0 to 10
Interval 4.0 to 7.0
|
4 score on a scale from 0 to 10
Interval 3.0 to 6.0
|
|
Post Operative Pain Scores
90 minutes
|
5 score on a scale from 0 to 10
Interval 3.0 to 6.0
|
3 score on a scale from 0 to 10
Interval 3.0 to 6.0
|
|
Post Operative Pain Scores
105 minutes
|
5 score on a scale from 0 to 10
Interval 3.0 to 7.0
|
3 score on a scale from 0 to 10
Interval 2.0 to 8.0
|
|
Post Operative Pain Scores
120 minutes
|
6.5 score on a scale from 0 to 10
Interval 5.0 to 7.0
|
3 score on a scale from 0 to 10
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Normal Saline
n=31 Participants
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
|
Acetaminophen
n=34 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.
|
|---|---|---|
|
Plasma Stress Markers
Epinephrine After IV
|
48 pg/ml
Interval 34.0 to 91.0
|
65 pg/ml
Interval 42.0 to 87.0
|
|
Plasma Stress Markers
Epinephrine In OR
|
42 pg/ml
Interval 24.0 to 52.0
|
58 pg/ml
Interval 37.0 to 108.0
|
|
Plasma Stress Markers
Epinephrine 1h in PACU
|
152 pg/ml
Interval 81.0 to 255.0
|
128 pg/ml
Interval 82.0 to 184.0
|
|
Plasma Stress Markers
Norepinephrine After IV
|
643 pg/ml
Interval 546.0 to 928.0
|
644 pg/ml
Interval 402.0 to 900.0
|
|
Plasma Stress Markers
Norepinephrine In OR
|
532 pg/ml
Interval 350.0 to 665.0
|
547 pg/ml
Interval 341.0 to 872.0
|
|
Plasma Stress Markers
Norepinephrine 1h in PACU
|
689 pg/ml
Interval 444.0 to 1054.0
|
884 pg/ml
Interval 533.0 to 1121.0
|
|
Plasma Stress Markers
Cortisol After IV
|
50.5 pg/ml
Interval 30.2 to 76.8
|
54.6 pg/ml
Interval 29.9 to 75.8
|
|
Plasma Stress Markers
Cortisol in OR
|
45.6 pg/ml
Interval 28.5 to 74.4
|
49 pg/ml
Interval 27.6 to 82.5
|
|
Plasma Stress Markers
Cortisol 1h in PACU
|
175.9 pg/ml
Interval 90.7 to 212.0
|
150.1 pg/ml
Interval 84.2 to 212.0
|
|
Plasma Stress Markers
IL-6 after IV
|
1.4 pg/ml
Interval 0.9 to 2.4
|
2.3 pg/ml
Interval 1.4 to 3.0
|
|
Plasma Stress Markers
IL-6 in OR
|
1.6 pg/ml
Interval 1.0 to 2.6
|
2 pg/ml
Interval 1.2 to 2.8
|
|
Plasma Stress Markers
IL-6 1h in PACU
|
7.9 pg/ml
Interval 4.6 to 11.1
|
9.9 pg/ml
Interval 5.6 to 13.0
|
|
Plasma Stress Markers
IL-8 after IV
|
8.7 pg/ml
Interval 6.7 to 10.4
|
8.3 pg/ml
Interval 5.7 to 10.7
|
|
Plasma Stress Markers
IL-8 in OR
|
6.6 pg/ml
Interval 5.5 to 10.1
|
6.4 pg/ml
Interval 4.7 to 8.4
|
|
Plasma Stress Markers
IL-8 1h in PACU
|
13.7 pg/ml
Interval 9.1 to 23.3
|
12.5 pg/ml
Interval 7.5 to 24.0
|
|
Plasma Stress Markers
IL-10 after IV
|
0.6 pg/ml
Interval 0.3 to 1.3
|
1 pg/ml
Interval 0.6 to 1.5
|
|
Plasma Stress Markers
IL-10 in OR
|
0.5 pg/ml
Interval 0.4 to 1.1
|
1.9 pg/ml
Interval 0.8 to 3.4
|
|
Plasma Stress Markers
IL-10 1h in PACU
|
1.9 pg/ml
Interval 0.8 to 3.4
|
1.9 pg/ml
Interval 1.3 to 3.3
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Normal Saline
n=31 Participants
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
|
Acetaminophen
n=34 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.
|
|---|---|---|
|
The Level of C-reactive Protein
CRP after IV
|
1062.6 pg/ml *1000
Interval 510.1 to 3741.4
|
1710.9 pg/ml *1000
Interval 714.2 to 3536.0
|
|
The Level of C-reactive Protein
CRP in OR
|
893.4 pg/ml *1000
Interval 370.3 to 2336.4
|
1410.7 pg/ml *1000
Interval 662.8 to 2943.2
|
|
The Level of C-reactive Protein
CRP 1h in PACU
|
746.6 pg/ml *1000
Interval 309.0 to 3861.0
|
1090.1 pg/ml *1000
Interval 449.2 to 3461.5
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Normal Saline
n=31 Participants
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
|
Acetaminophen
n=34 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.
|
|---|---|---|
|
Time to Rescue Pain Medication
|
19 minutes
Interval 15.0 to 28.0
|
23 minutes
Interval 17.0 to 30.0
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Normal Saline
n=31 Participants
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
|
Acetaminophen
n=34 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.
|
|---|---|---|
|
Total Dosage of Post Operative Opioids
|
1.2 mg
Interval 1.0 to 1.6
|
1 mg
Interval 0.6 to 1.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Normal Saline
n=31 Participants
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
|
Acetaminophen
n=34 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.
|
|---|---|---|
|
Patient Satisfaction Survey
|
4 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hourNumber of Participants with Post Operative Nausea and Vomiting
Outcome measures
| Measure |
Normal Saline
n=31 Participants
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
|
Acetaminophen
n=34 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.
|
|---|---|---|
|
Number of Participants With Post Operative Nausea and Vomiting
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hourNumber of Participants Requiring Additional Anti-emetics (anti-vomiting)
Outcome measures
| Measure |
Normal Saline
n=31 Participants
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
|
Acetaminophen
n=34 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.
|
|---|---|---|
|
Number of Participants Requiring Additional Anti-emetics
|
8 Participants
|
7 Participants
|
Adverse Events
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acetaminophen
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Saline
n=41 participants at risk
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
|
Acetaminophen
n=47 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Surgical complication
|
0.00%
0/41 • 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
|
4.3%
2/47 • Number of events 2 • 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
|
Additional Information
Dr. Michal Gajewski, DO
CHRISTUS St. Vincent Regional Medical Center
Phone: (505) 913-3361
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place