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IV Acetaminophen as an Adjunct Analgesic in Cardiac Surgery (CarDolMev)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01544062
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Srdjan Jelacic, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Acute Pain
Hyperalgesia
Interventions Drug: IV acetaminophen
Drug: Placebo
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Acetaminophen Normal Saline
Hide Arm/Group Description

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving placebo
Period Title: Overall Study
Started 33 35
Completed 33 35
Not Completed 0 0
Arm/Group Title IV Acetaminophen Normal Saline Total
Hide Arm/Group Description

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving placebo Total of all reporting groups
Overall Number of Baseline Participants 33 35 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  75.8%
22
  62.9%
47
  69.1%
>=65 years
8
  24.2%
13
  37.1%
21
  30.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
Female
4
  12.1%
12
  34.3%
16
  23.5%
Male
29
  87.9%
23
  65.7%
52
  76.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 35 participants 68 participants
33 35 68
1.Primary Outcome
Title 24 Hour Postoperative Opioid Consumption
Hide Description The 24 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.
Time Frame 24 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for 1 study subject in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 34 33
Mean (Standard Deviation)
Unit of Measure: mg
62.3  (29.5) 45.6  (29.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.7
Confidence Interval (2-Sided) 95%
2.3 to 31.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments controlling for age, sex and body mass index
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title 48 Hour Postoperative Opioid Consumption
Hide Description 48 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.
Time Frame 48 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for 1 study subject in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:
Study subjects receiving placebo

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 34 33
Mean (Standard Deviation)
Unit of Measure: mg
105.1  (42.1) 85.1  (42.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments controlling for age, sex and body mass index
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title 24 Hour Postoperative Pain Scores at Rest
Hide Description Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).
Time Frame 24 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for 3 study subjects in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:
Study subjects receiving placebo

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.9  (2.3) 3.7  (2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.724
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments controlling for age, sex and body mass index
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title 48 Hour Postoperative Pain Scores at Rest
Hide Description Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).
Time Frame 48 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 2 study subjects in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:
Study subjects receiving placebo

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.4  (2.2) 2.0  (1.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.397
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.458
Comments controlling for age, sex and body mass index
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title 24 Hour Postoperative Pain Scores With Movement
Hide Description Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).
Time Frame 24 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 3 study subjects in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:
Study subjects receiving placebo

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (2.5) 6.0  (2.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.600
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.509
Comments [Not Specified]
Method ANCOVA
Comments controlling for age, sex and body mass index
6.Secondary Outcome
Title 48 Hour Postoperative Pain Scores With Movement
Hide Description Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).
Time Frame 48 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 2 study subjects in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:
Study subjects receiving placebo

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.1  (2.9) 4.6  (2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.399
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.395
Comments controlling for age, sex and body mass index
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title 24 Hour Wound Hyperalgesia
Hide Description Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).
Time Frame 24 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 3 study subjects in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: cm
4.8  (4.3) 4.5  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.771
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.927
Comments controlling for age, sex and body mass index
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title 48 Hour Wound Hyperalgesia
Hide Description Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).
Time Frame 48 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 2 study subjects in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: cm
4.6  (3.9) 5.0  (3.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.644
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments controlling for age, sex and body mass index
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Length of Mechanical Ventilation
Hide Description The length of mechanical ventilation will be determined based on the "Extubation Criteria" checklist that will be completed by nursing staff every 2 hours until extubation.
Time Frame From the time of arrival in ICU until extubation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 35 33
Mean (Standard Deviation)
Unit of Measure: minutes
407  (683) 360  (276)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.710
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments controlling for age, sex and body mass index
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Length of ICU Stay
Hide Description The length of ICU stay will be determined based on the "ICU Discharge Criteria" checklist that will be completed by nursing staff every 4 hours until ICU discharge.
Time Frame From the time of arrival in ICU until ICU discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 35 33
Mean (Standard Deviation)
Unit of Measure: hours
67  (35) 61  (27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.508
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.905
Comments controlling for age, sex and body mass index
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title 48 Hour Patient Satisfaction
Hide Description "The extent to which subjects overall pain experience met their expectations" question responses were converted to the Likert scale with the following values: not at all (1), a little (2), a fair amount (3), very much (4) and extremely well (5).
Time Frame 48 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Questionnaire not completed by 12 study subjects in normal saline group and 10 study subjects in IV acetaminophen group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (1.2) 2.8  (0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.104
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title 24 Hour Nausea
Hide Description Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).
Time Frame 24 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 35 33
Measure Type: Number
Unit of Measure: participants
25 26
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.580
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
13.Secondary Outcome
Title 48 Hour Nausea
Hide Description Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).
Time Frame 48 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 35 33
Measure Type: Number
Unit of Measure: participants
12 14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.619
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
14.Secondary Outcome
Title 24 Hour Pruritus
Hide Description Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).
Time Frame 24 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 3 study subjects in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 32 33
Measure Type: Number
Unit of Measure: participants
4 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.511
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
15.Secondary Outcome
Title 48 Hour Pruritus
Hide Description Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).
Time Frame 48 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 8 study subjects in normal saline group and 6 study subjects in IV acetaminophen group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 27 27
Measure Type: Number
Unit of Measure: participants
4 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.501
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
16.Secondary Outcome
Title 24 Hour Sedation
Hide Description Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).
Time Frame 24 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 3 study subjects in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 32 33
Measure Type: Number
Unit of Measure: participants
8 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
17.Secondary Outcome
Title 48 Hour Sedation
Hide Description Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).
Time Frame 48 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 6 study subjects in normal saline group and 3 study subjects in IV acetaminophen group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 29 30
Measure Type: Number
Unit of Measure: participants
6 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.299
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
18.Secondary Outcome
Title 24 Hour Respiratory Depression
Hide Description Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).
Time Frame 24 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 3 study subjects in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 32 33
Measure Type: Number
Unit of Measure: participants
2 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
19.Secondary Outcome
Title 48 Hour Respiratory Depression
Hide Description Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).
Time Frame 48 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 6 study subjects in normal saline group and 3 study subjects in IV acetaminophen group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 29 30
Measure Type: Number
Unit of Measure: participants
1 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.492
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
20.Secondary Outcome
Title 24 Hour Dizziness
Hide Description Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).
Time Frame 24 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 3 study subjects in normal saline group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 32 33
Measure Type: Number
Unit of Measure: participants
20 17
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.455
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
21.Secondary Outcome
Title 48 Hour Dizziness
Hide Description Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).
Time Frame 48 hours after arriving in ICU
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data on 7 study subjects in normal saline group and 4 study subjects in IV acetaminophen group.
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description:

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Overall Number of Participants Analyzed 28 29
Measure Type: Number
Unit of Measure: participants
9 10
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Saline, IV Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 18 month period between July 2012 and December 2013
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal Saline IV Acetaminophen
Hide Arm/Group Description

Study subjects receiving placebo

Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

All-Cause Mortality
Normal Saline IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Normal Saline IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Normal Saline IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/33 (0.00%) 
  • several subjects received intraoperative hydromorphone while others only received intraoperative fentanyl
  • significantly greater proportion of females in the placebo group
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
Layout table for Results Point of Contact information
Name/Title: Srdjan Jelacic, MD
Organization: University of Washington
Phone: (206) 598-3777
EMail: sjelacic@uw.edu
Layout table for additonal information
Responsible Party: Srdjan Jelacic, University of Washington
ClinicalTrials.gov Identifier: NCT01544062    
Other Study ID Numbers: 42204-D
First Submitted: February 28, 2012
First Posted: March 5, 2012
Results First Submitted: November 30, 2015
Results First Posted: June 21, 2016
Last Update Posted: June 21, 2016