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Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

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ClinicalTrials.gov Identifier: NCT01822821
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Other
Condition Pain
Interventions Drug: IV Acetaminophen
Drug: Placebo
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Period Title: Overall Study
Started 75 75
Completed 73 74
Not Completed 2 1
Reason Not Completed
Eligible surgery cancelled             1             1
Other reasons             1             0
Arm/Group Title IV Acetaminophen Placebo Total
Hide Arm/Group Description

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Total of all reporting groups
Overall Number of Baseline Participants 73 74 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 74 participants 147 participants
62  (14) 59  (14) 60.5  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 74 participants 147 participants
Female
24
  32.9%
24
  32.4%
48
  32.7%
Male
49
  67.1%
50
  67.6%
99
  67.3%
1.Primary Outcome
Title Cumulative Opioid Consumption
Hide Description Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption a after cardiac surgery. Total opioid consumption is defined as the total amount amount of opioids administered to patients converted to mg morphine equivalents.
Time Frame End of surgery through 24 hours after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Overall Number of Participants Analyzed 73 74
Median (Inter-Quartile Range)
Unit of Measure: mg morphine equivalents
97
(58 to 136)
117
(66 to 174)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was tested using a noninferiority margin of 1.15.
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 0.89
Confidence Interval (1-Sided) 90%
1.06
Estimation Comments Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 0.89
Confidence Interval (1-Sided) 95%
1.10
Estimation Comments Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.
2.Primary Outcome
Title Pain Intensity
Hide Description Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing pain intensity scores after cardiac surgery. Pain scores were measured on the Numeric Rating scale, ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst pain imaginable).
Time Frame End of surgery through 24 hours after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients had at least one postoperative pain scores. Some patients did not have a pain score at particular time points if they were unavailable (e.g., at a test), unable to speak (e.g., intubated), asleep, or similar reasons. We report any available pain scores at each time they were collected.
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Overall Number of Participants Analyzed 73 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
overall pain scores Number Analyzed 73 participants 74 participants
3.1  (1.6) 4.0  (1.4)
4 hours after surgery Number Analyzed 59 participants 62 participants
4.6  (2.9) 5.0  (3.1)
6 hours after surgery Number Analyzed 63 participants 66 participants
3.5  (2.4) 4.4  (2.4)
8 hours after surgery Number Analyzed 64 participants 71 participants
3.2  (2.6) 4.4  (2.3)
12 hours after surgery Number Analyzed 71 participants 72 participants
2.4  (2.5) 3.5  (2.6)
16 hours after surgery Number Analyzed 72 participants 72 participants
3.0  (2.4) 3.6  (2.4)
20 hours after surgery Number Analyzed 72 participants 69 participants
2.9  (2.1) 4.2  (2.0)
24 hours after surgery Number Analyzed 72 participants 74 participants
2.5  (2.1) 3.5  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments We assessed whether IV acetaminophen is noninferior to placebo using a noninferiority margin of 1.0.
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.9
Confidence Interval (1-Sided) 90%
-0.5
Estimation Comments Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (1-Sided) 95%
-0.42
Estimation Comments Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.
3.Secondary Outcome
Title Postoperative Nausea and Vomiting
Hide Description Incidence of any postoperative nausea and vomiting within 24 hours after surgery was collected.
Time Frame End of surgery through 24 hours after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Overall Number of Participants Analyzed 73 74
Measure Type: Count of Participants
Unit of Measure: Participants
16
  21.9%
21
  28.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.76
Confidence Interval (2-Sided) 99.4%
0.34 to 1.7
Estimation Comments Relative risk of PONV in IV acetaminophen versus placebo patients estimated from a multivariable logistic regression model using the log link and adjusting for age and diabetes.
4.Secondary Outcome
Title Postoperative Sedation
Hide Description Postoperative sedation was assessed using the Richmond Agitation Sedation Scale (RASS). It ranges from -5 to +4, where -5 indicates no response to voice or physical stimulation and +4 indicates overtly combative or violent and immediate danger to staff. Lower the value, better the sedation.
Time Frame Measured at 8, 16, and 24 hours after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
RASS scores were not collected at certain time points if patients were not available (e.g., patient was away at a test) or if staff were not available.
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Overall Number of Participants Analyzed 73 74
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
8 hours after surgery Number Analyzed 48 participants 41 participants
0
(-1 to 0)
0
(-1 to 0)
16 hours after surgery Number Analyzed 39 participants 43 participants
0
(-1 to 0)
0
(0 to 0)
24 hours after surgery Number Analyzed 73 participants 74 participants
0
(0 to 0)
0
(0 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments Analysis at 8 hours after surgery.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0
Confidence Interval (2-Sided) 99.8%
0 to 0
Estimation Comments Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments Analysis at 16 hours after surgery.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0
Confidence Interval (2-Sided) 99.8%
0 to 0
Estimation Comments Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments Analysis at 24 hours after surgery
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Confidence Interval (2-Sided) 99.8%
0 to 0
Estimation Comments Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.
5.Secondary Outcome
Title Duration of Mechanical Ventilation (Minutes)
Hide Description Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation.
Time Frame End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Overall Number of Participants Analyzed 73 74
Median (Inter-Quartile Range)
Unit of Measure: minutes
214
(143 to 345)
190
(139 to 381)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 1.3
Confidence Interval (2-Sided) 99.4%
0.52 to 3.20
Estimation Comments Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.
6.Secondary Outcome
Title Intensive Care Unit (ICU) Length of Stay
Hide Description Evaluate whether IV acetaminophen reduced intensive care unit (ICU) Length of Stay.
Time Frame End of surgery through discharge from ICU
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Overall Number of Participants Analyzed 73 74
Median (Inter-Quartile Range)
Unit of Measure: hours
214
(143 to 345)
190
(139 to 381)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 0.93
Confidence Interval (2-Sided) 99.4%
0.74 to 1.20
Estimation Comments Outcome log-transformed to meet model assumptions. The treatment effect on duration of ICU stay was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.
7.Secondary Outcome
Title Hospital Length of Stay
Hide Description Evaluate whether IV acetaminophen hospital length of stay
Time Frame end of surgery through hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Overall Number of Participants Analyzed 73 74
Median (Inter-Quartile Range)
Unit of Measure: days
6.2
(5.3 to 7.3)
6.1
(5.1 to 7.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 1.1
Confidence Interval (2-Sided) 99.4%
0.94 to 1.20
Estimation Comments Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.
8.Secondary Outcome
Title Alanine Aminotransferase (ALT); U/L
Hide Description [Not Specified]
Time Frame Two days after surgery or date of death from any cause, whichever came first
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Overall Number of Participants Analyzed 73 74
Median (Inter-Quartile Range)
Unit of Measure: U/L
Overall ALT
18
(15 to 23)
19
(15 to 24)
postoperative day 1 ALT
18
(16 to 24)
19
(15 to 25)
postoperative day 2 ALT
17
(14 to 22)
18
(15 to 23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 1.1
Confidence Interval (2-Sided) 99.4%
0.9 to 1.2
Estimation Comments Outcome log-transformed to meet model assumptions. The treatment effect on ALT was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.
9.Secondary Outcome
Title Aspartate Aminotransferase (AST); U/L
Hide Description [Not Specified]
Time Frame Two days after surgery or date of death from any cause, whichever came first
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Overall Number of Participants Analyzed 73 74
Median (Inter-Quartile Range)
Unit of Measure: U/L
Overall AST
35
(30 to 45)
33
(29 to 51)
postoperative day 1 AST
40
(32 to 54)
40
(32 to 57)
postoperative day 2 AST
31
(24 to 42)
31
(23 to 45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 1.0
Confidence Interval (2-Sided) 99.4%
0.8 to 1.2
Estimation Comments Outcome log-transformed to meet model assumptions. The treatment effect on AST was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.
10.Secondary Outcome
Title Total Bilirubin (mg/dL)
Hide Description [Not Specified]
Time Frame Measured at 1 day and 2 days after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Overall Number of Participants Analyzed 73 74
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
overall bilirubin
0.7
(0.5 to 0.9)
0.7
(0.5 to 0.8)
postoperative day 1 bilirubin
0.7
(0.5 to 1.0)
0.7
(0.5 to 0.8)
postoperative day 2 bilirubin
0.6
(0.4 to 0.8)
0.6
(0.4 to 0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of geometric means
Estimated Value 1.1
Confidence Interval (2-Sided) 99.4%
0.87 to 1.3
Estimation Comments Outcome log-transformed to meet model assumptions. The treatment effect on bilirubin was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

All-Cause Mortality
IV Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/73 (0.00%)   0/74 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/73 (0.00%)   0/74 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Nicole Zimmerman
Organization: Cleveland Clinic
Phone: 216-636-9449
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01822821     History of Changes
Other Study ID Numbers: 13-269
First Submitted: March 28, 2013
First Posted: April 2, 2013
Results First Submitted: January 20, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017