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Trial record 6 of 1936 for:    ACETAMINOPHEN

Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty

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: NCT02839876
Recruitment Status : Completed
First Posted : July 21, 2016
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Osteoarthritis
Acetaminophen
Arthroplasty, Hip Replacement
Interventions Drug: Intravenous acetaminophen
Drug: Oral acetaminophen
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Period Title: Overall Study
Started 41 40
Completed 31 29
Not Completed 10 11
Reason Not Completed
Protocol Violation             10             11
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen Total
Hide Arm/Group Description

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Total of all reporting groups
Overall Number of Baseline Participants 31 29 60
Hide Baseline Analysis Population Description
Only completed participants are included.
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 31 participants 29 participants 60 participants
65
(61 to 71)
63
(59 to 67)
64.5
(60.5 to 70.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
Female
10
  32.3%
16
  55.2%
26
  43.3%
Male
21
  67.7%
13
  44.8%
34
  56.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
American Indian or Alaska Native
1
   3.2%
0
   0.0%
1
   1.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.2%
5
  17.2%
6
  10.0%
White
23
  74.2%
23
  79.3%
46
  76.7%
More than one race
5
  16.1%
1
   3.4%
6
  10.0%
Unknown or Not Reported
1
   3.2%
0
   0.0%
1
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 29 participants 60 participants
31 29 60
ASA Physical Classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
ASA I
1
   3.2%
0
   0.0%
1
   1.7%
ASA II
17
  54.8%
19
  65.5%
36
  60.0%
ASA III
13
  41.9%
10
  34.5%
23
  38.3%
[1]
Measure Description: Participants were classified per the American Society of Anesthesiologists (ASA) Physical Class I-III. ASA I = A normal healthy patient; ASA II = A patient with mild systemic disease; ASA III = A patient with severe systemic disease
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 31 participants 29 participants 60 participants
87.99  (21.90) 87.25  (18.79) 87.63  (20.29)
1.Primary Outcome
Title 24 Hour Opioid Consumption
Hide Description Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Only completed participants are included.
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: morphine milliequivalent
3.0
(1.9 to 6.0)
3.4
(2.0 to 5.9)
2.Secondary Outcome
Title Opioid Consumption (Other)
Hide Description morphine equivalent units of intravenous and oral opioids
Time Frame 0-48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: morphine milliequivalent
6.2
(3.0 to 12.1)
6.8
(3.9 to 11.7)
3.Secondary Outcome
Title Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
Hide Description Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame preoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
7.0
(5.0 to 8.0)
7.0
(6.0 to 8.0)
4.Secondary Outcome
Title Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
Hide Description Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame 1 hour after arrival to PACU
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
1.0
(0.0 to 3.75)
1.0
(0.0 to 3.0)
5.Secondary Outcome
Title Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
Hide Description Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
2.0
(0.0 to 4.75)
3.0
(0.0 to 5.0)
6.Secondary Outcome
Title Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
Hide Description Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
2.0
(1.0 to 3.5)
1.0
(0.0 to 3.0)
7.Secondary Outcome
Title Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
Hide Description Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame 36 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
3.0
(1.0 to 4.0)
2.0
(0.75 to 3.0)
8.Secondary Outcome
Title Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
Hide Description Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
2.0
(1.0 to 3.0)
2.0
(0.0 to 3.0)
9.Secondary Outcome
Title Subject Satisfaction at 24 Hours
Hide Description Overall subject satisfaction with hospital experience at the 24 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Only completed participants are included.
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
9
(8 to 10)
9
(8 to 10)
10.Secondary Outcome
Title Subject Satisfaction at 48 Hours (48 Hours)
Hide Description Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Only completed participants are included.
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
9
(8 to 10)
9
(9 to 10)
11.Secondary Outcome
Title Straight Leg Raise
Hide Description Number of participants who are able to complete the active straight leg test. The subject rests supine and is asked to lift his/her operative lower limb (with knee extended) until the ankle is 20 cm from level. If the subject can do this, the test is positive.
Time Frame Postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Only completed participants are included.
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Measure Type: Count of Participants
Unit of Measure: Participants
16
  51.6%
11
  37.9%
12.Secondary Outcome
Title Heel Slide Test
Hide Description Number of participants who are able to complete the heel-slide test. The subject rests supine and is asked to place the heel of his/her operative side on the contralateral knee, then slide the heel down to the ankle and back in one continuous motion. If the subject can do this, the test is positive. If the subject cannot do this in one motion, or if pain or other factors prevent the test from being performed, the test is negative.
Time Frame Postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Only completed participants are included.
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Measure Type: Count of Participants
Unit of Measure: Participants
25
  80.6%
16
  55.2%
13.Secondary Outcome
Title Number of Participants Able to Complete the Supine to Sit Test
Hide Description Number of participants able to go from supine to a sitting position independently.
Time Frame Postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Only completed participants are included.
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Measure Type: Count of Participants
Unit of Measure: Participants
10
  32.3%
6
  20.7%
14.Secondary Outcome
Title Self-paced Walk Test
Hide Description Time taken to walk down a hallway 20 m at a safe and quick pace, turn around and return to starting point.
Time Frame Postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Only completed participants are included.
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Mean (Inter-Quartile Range)
Unit of Measure: seconds
86
(41 to 1641)
63
(43 to 1328)
15.Secondary Outcome
Title Number of Participants With Opioid-related Adverse Events
Hide Description Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation
Time Frame 0-72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Only completed participants are included.
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Measure Type: Number
Unit of Measure: participants
15 7
16.Secondary Outcome
Title Analgesic Consumption as Measured by Patient Diary
Hide Description morphine equivalent units of oral opioids and other non-opioids
Time Frame day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: mg
0
(0 to 0)
0
(0 to 0)
17.Secondary Outcome
Title Worst Pain (Day 30)
Hide Description Participants are asked to rate their WORST pain on POSTOPERATIVE DAY 30 on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
1.0
(0.0 to 2)
0
(0 to 3)
18.Secondary Outcome
Title Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
Hide Description Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame preoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
1.0
(0.0 to 4.0)
2.0
(0.0 to 5.0)
19.Secondary Outcome
Title Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
Hide Description Pain scores (using NRS-11 scale) at with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame 1 hour after arrival to PACU
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
2.0
(0.0 to 4.75)
2.0
(0.0 to 4.0)
20.Secondary Outcome
Title Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
Hide Description Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
3.0
(1.0 to 5.0)
5.5
(3.75 to 7.25)
21.Secondary Outcome
Title Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
Hide Description Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
5.0
(3.0 to 7.5)
4.0
(3.0 to 7.0)
22.Secondary Outcome
Title Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
Hide Description Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame 36 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
5.0
(3.0 to 70)
4.5
(3.75 to 6.0)
23.Secondary Outcome
Title Subject Satisfaction at 48 Hours
Hide Description Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Only completed participants are included.
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
9
(8 to 10)
9
(9 to 10)
24.Secondary Outcome
Title Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
Hide Description Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
5.0
(3.0 to 6.0)
5.0
(2.5 to 6.0)
25.Other Pre-specified Outcome
Title Hospital Length of Stay
Hide Description Time to both discharge readiness and to actual discharge
Time Frame 0-72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Only completed participants are included.
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: days
1
(1 to 2)
1
(1 to 2)
26.Other Pre-specified Outcome
Title Overall Hospital Admission Costs
Hide Description difference in total hospital admission cost between groups
Time Frame 0-72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: US dollars
14682
(13468 to 16353)
14782
(13461 to 17013)
27.Other Pre-specified Outcome
Title Pharmacy-related Costs
Hide Description difference in pharmacy-related cost between groups
Time Frame 0-72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: US dollars
498
(465 to 518)
510
(459 to 539)
28.Other Pre-specified Outcome
Title Costs Related to Opioid-related Adverse Events
Hide Description difference in cost related to treatment of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) between groups
Time Frame 0-72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: US dollars
0.80  (1.18) 0.85  (1.73)
29.Other Pre-specified Outcome
Title Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events
Hide Description mean cost (per patient) related to nursing care of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) in $USD
Time Frame 0-72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description:

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: US dollars
1.86  (2.68) 1.82  (3.50)
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Acetaminophen Oral Acetaminophen
Hide Arm/Group Description

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

All-Cause Mortality
Intravenous Acetaminophen Oral Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)      0/29 (0.00%)    
Hide Serious Adverse Events
Intravenous Acetaminophen Oral Acetaminophen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      1/29 (3.45%)    
Surgical and medical procedures     
Postoperative hematoma  [1]  0/31 (0.00%)  0 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
[1]
Postoperative infected hematoma, admitted to hospital, treated with surgery and antibiotics
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravenous Acetaminophen Oral Acetaminophen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/31 (41.94%)      13/29 (44.83%)    
Cardiac disorders     
Dizziness/orthostasis   7/31 (22.58%)  7 1/29 (3.45%)  1
Gastrointestinal disorders     
Nausea   9/31 (29.03%)  10 3/29 (10.34%)  3
constipation   3/31 (9.68%)  3 4/29 (13.79%)  4
Infections and infestations     
wound erythema/drainage   1/31 (3.23%)  1 3/29 (10.34%)  3
Fever   1/31 (3.23%)  1 0/29 (0.00%)  0
Investigations     
Abnormal lab values (INR)   1/31 (3.23%)  1 0/29 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Hip dislocation   0/31 (0.00%)  0 1/29 (3.45%)  1
Nervous system disorders     
Polyneuropathy, peripheral   0/31 (0.00%)  0 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders     
Pruritis   2/31 (6.45%)  2 0/29 (0.00%)  0
Indicates events were collected by systematic assessment
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: Dr. Jeff Gadsden
Organization: Duke University Medical Center
Phone: 919-681-6437
EMail: jeff.gadsden@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02839876    
Other Study ID Numbers: Pro00072610
First Submitted: July 19, 2016
First Posted: July 21, 2016
Results First Submitted: October 8, 2019
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020