Trial Outcomes & Findings for IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population (NCT NCT03198871)
NCT ID: NCT03198871
Last Updated: 2021-01-28
Results Overview
Number of patients with unsatisfactory pain relief defined as average numeric rating scale (NRS) more than 5 will be compared between the two groups. This may include patients using IVPCA for pain relief during the first 48 hours postoperative.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively.
Results posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
Acetaminophen Injectable Product
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
76
|
78
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population
Baseline characteristics by cohort
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
64 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
78 participants
n=7 Participants
|
154 participants
n=5 Participants
|
|
Basal Metabolic Index
|
27.7 kg/m^2
n=5 Participants
|
28.25 kg/m^2
n=7 Participants
|
28.15 kg/m^2
n=5 Participants
|
|
Charlson Comorbidity Index
0
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Charlson Comorbidity Index
1
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Charlson Comorbidity Index
2
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Charlson Comorbidity Index
>2
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
American Society of Anesthesiologists Classification
II
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
American Society of Anesthesiologists Classification
III
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
American Society of Anesthesiologists Classification
IV
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Number of participants taking medications for mental health
|
15 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Diabetes
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Hypertension
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Coronary artery disease
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Congestive failure
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Atrial fibrillation
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Pulmonary disease
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Malignancy
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Preoperative serum creatinine
|
0.8 (mg/dL)
n=5 Participants
|
0.82 (mg/dL)
n=7 Participants
|
0.81 (mg/dL)
n=5 Participants
|
PRIMARY outcome
Timeframe: PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively.Number of patients with unsatisfactory pain relief defined as average numeric rating scale (NRS) more than 5 will be compared between the two groups. This may include patients using IVPCA for pain relief during the first 48 hours postoperative.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Postoperative Pain Intensity
|
33 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes firstRescue analgesia will be given according to institutional pain management protocol. Unit of Measure recorded as OME (Oral Morphine Equivalent) consumption in mg.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Total Post-operative Narcotic Consumption
0-24 hours
|
27.4 mg
Interval 10.0 to 49.0
|
36 mg
Interval 17.5 to 85.0
|
|
Total Post-operative Narcotic Consumption
24-48 hours
|
31.3 mg
Interval 7.5 to 73.3
|
45 mg
Interval 15.0 to 95.0
|
|
Total Post-operative Narcotic Consumption
48-72 hours
|
30 mg
Interval 0.0 to 70.0
|
37.5 mg
Interval 0.0 to 70.0
|
|
Total Post-operative Narcotic Consumption
0-48 hours
|
74 mg
Interval 25.5 to 113.0
|
88.8 mg
Interval 42.5 to 167.5
|
|
Total Post-operative Narcotic Consumption
0-72 hours
|
105.00 mg
Interval 41.3 to 186.3
|
127.1 mg
Interval 49.3 to 252.0
|
SECONDARY outcome
Timeframe: From time of PACU admission until the time of discharge, assessed up to 24 hours postoperativelyThe time from PACU admission to PACU discharge to the floor will be measured.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU)
|
129.00 minutes
Interval 106.0 to 186.0
|
152.50 minutes
Interval 98.5 to 208.5
|
SECONDARY outcome
Timeframe: From time patient left operating room until the time of first documented bowel movement, assessed up to hospital dischargeThe time it takes for the first bowel movement postoperatively will be measured.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Time to Bowel Movement
|
46.30 hours
Interval 25.38 to 90.85
|
64.66 hours
Interval 29.27 to 115.33
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperativelyThe time it takes for the patient to ingest orally post-surgery will be measured.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Time to Oral Intake
|
12.15 hours
Interval 4.53 to 33.17
|
9.40 hours
Interval 3.87 to 43.38
|
SECONDARY outcome
Timeframe: From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperativelyThe time it takes for the patient to successfully ambulate post-surgery will be measured.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Time to Ambulation
|
18.82 hours
Interval 4.42 to 37.77
|
17.38 hours
Interval 4.28 to 22.65
|
SECONDARY outcome
Timeframe: From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes firstThe time it takes for the patient to be fully discharged from the hospital post-surgery will be measured.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Time to Hospital Discharge
|
4.08 days
Interval 3.07 to 6.04
|
4.94 days
Interval 3.94 to 7.12
|
SECONDARY outcome
Timeframe: From the time of consent until 30 days post-operativelyIf the patient is readmitted to the hospital after being fully discharged, the event will be recorded.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Number of Participants With Readmission to the Hospital
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: These measurements will be taken at time of discharge up to 30 days, whichever comes firstOverall patient satisfaction as well as satisfaction relating to pain management and cost analyses will be measured. These will be measured with a numerical rating scale (NRS) with 0- being worst satisfaction and 10 - best satisfaction.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Patient Satisfaction
Patient satisfaction score, overall
|
10 score on a scale
Interval 9.0 to 10.0
|
10 score on a scale
Interval 9.0 to 10.0
|
|
Patient Satisfaction
Patient Satisfaction score, pain management
|
10 score on a scale
Interval 9.0 to 10.0
|
10 score on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: The delirium scores will first be measured every 12 hours for 72 hours after surgery.Number of patients who score greater than a 4 on the 0-8 point ICDSC scale to assess delirium scores. 8 separate levels of signs for delirium assessed (1. altered level of consciousness, 2. inattention, 3. disorientation, 4. hallucination, delusion, or psychosis, 5. psychomotor agitation or retardation, 6. inappropriate speech or mood, 7. sleep-wake cycle disturbance, 8. symptom fluctuation), with 0 points awarded when patient does not exhibit above signs of delirium and 1 point awarded per confirmed sign of delirium. Score then totaled, 0 = normal, 1-3 = subsyndromal delirium, 4-8 = delirium.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Intensive Care Delirium Screening Checklist (ICDSC)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: These will be evaluated from the time of PACU admission until 72 hours postoperatively.Nausea will be evaluated by nausea score from 0 to 10, with 0 equaling no nausea and 10 equaling the worst nausea imaginable.
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Post-operative Nausea
Nausea score POD 3 (pm visit)
|
0.56 score on a scale
Standard Deviation 1.77
|
0.78 score on a scale
Standard Deviation 2.42
|
|
Post-operative Nausea
Nausea score POD 1 (am visit)
|
1.13 score on a scale
Standard Deviation 2.82
|
0.60 score on a scale
Standard Deviation 1.76
|
|
Post-operative Nausea
Nausea score POD 1 (pm visit)
|
0.49 score on a scale
Standard Deviation 1.54
|
0.92 score on a scale
Standard Deviation 2.53
|
|
Post-operative Nausea
Nausea score POD 2 (am visit)
|
0.71 score on a scale
Standard Deviation 1.97
|
0.75 score on a scale
Standard Deviation 2.39
|
|
Post-operative Nausea
Nausea score POD 2 (pm visit)
|
0.55 score on a scale
Standard Deviation 1.70
|
0.69 score on a scale
Standard Deviation 2.36
|
|
Post-operative Nausea
Nausea score POD 3 (am visit)
|
0.32 score on a scale
Standard Deviation 1.37
|
0.66 score on a scale
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: These will be evaluated from the time of PACU admission until 72 hours postoperatively.Frequency of emesis and rescue antiemetic requirement will be documented
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Post-operative Emesis
Emesis incidence 0-72 hours
|
12 Participants
|
14 Participants
|
|
Post-operative Emesis
Antiemetic use
|
31 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: These measurements will take place at 30-days post hospital dischargeSurvey to assess patient's overall health (via a combination of mental and physical health assessment) at 30 days post-discharge. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
Outcome measures
| Measure |
Acetaminophen Injectable Product
n=76 Participants
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 Participants
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
SF-12 Health Survey
SF 12 Physical score
|
38.72 Z-scores (difference compared to the pop
Interval 30.73 to 43.28
|
38.07 Z-scores (difference compared to the pop
Interval 32.56 to 45.85
|
|
SF-12 Health Survey
SF 12 Mental score
|
54.02 Z-scores (difference compared to the pop
Interval 48.33 to 57.42
|
52.08 Z-scores (difference compared to the pop
Interval 42.66 to 57.88
|
Adverse Events
Acetaminophen Injectable Product
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Sodium Chloride 0.9%, Intravenous
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acetaminophen Injectable Product
n=76 participants at risk
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 participants at risk
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.6%
2/76 • 30 Days
|
1.3%
1/78 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
1.3%
1/76 • 30 Days
|
1.3%
1/78 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pnemonia
|
0.00%
0/76 • 30 Days
|
1.3%
1/78 • 30 Days
|
Other adverse events
| Measure |
Acetaminophen Injectable Product
n=76 participants at risk
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
|
Sodium Chloride 0.9%, Intravenous
n=78 participants at risk
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.6%
2/76 • 30 Days
|
0.00%
0/78 • 30 Days
|
|
Surgical and medical procedures
Anastomotic Leak
|
2.6%
2/76 • 30 Days
|
2.6%
2/78 • 30 Days
|
|
Renal and urinary disorders
Urinary Retention
|
2.6%
2/76 • 30 Days
|
3.8%
3/78 • 30 Days
|
|
Gastrointestinal disorders
Prolonged Ileus
|
1.3%
1/76 • 30 Days
|
2.6%
2/78 • 30 Days
|
|
Surgical and medical procedures
Pancreatic Leak
|
0.00%
0/76 • 30 Days
|
1.3%
1/78 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
1.3%
1/76 • 30 Days
|
0.00%
0/78 • 30 Days
|
Additional Information
Dr. Kathirvel Subramaniam MD MPH FASE
University of Pittsburgh School of Medicine / UPMC
Phone: 7247995852
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place