Trial Outcomes & Findings for Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty (NCT NCT02839876)

NCT ID: NCT02839876

Last Updated: 2021-03-09

Results Overview

Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 81 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2021-03-09

Participant Flow

Participant milestones

Measure	Intravenous Acetaminophen 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.	Oral Acetaminophen 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 Study STARTED	41	40
Overall Study COMPLETED	31	29
Overall Study NOT COMPLETED	10	11

Reasons for withdrawal

Measure	Intravenous Acetaminophen 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.	Oral Acetaminophen 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 Study Protocol Violation	10	11

Baseline Characteristics

Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty

Baseline characteristics by cohort

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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 n=60 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	63 years n=7 Participants	64.5 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	29 participants n=7 Participants	60 participants n=5 Participants
ASA Physical Classification ASA I	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
ASA Physical Classification ASA II	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
ASA Physical Classification ASA III	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Weight	87.99 kilograms STANDARD_DEVIATION 21.90 • n=5 Participants	87.25 kilograms STANDARD_DEVIATION 18.79 • n=7 Participants	87.63 kilograms STANDARD_DEVIATION 20.29 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Only completed participants are included.

Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
24 Hour Opioid Consumption	3.0 morphine milliequivalent Interval 1.9 to 6.0	3.4 morphine milliequivalent Interval 2.0 to 5.9

SECONDARY outcome

Timeframe: 0-48 hours

morphine equivalent units of intravenous and oral opioids

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Opioid Consumption (Other)	6.2 morphine milliequivalent Interval 3.0 to 12.1	6.8 morphine milliequivalent Interval 3.9 to 11.7

SECONDARY outcome

Timeframe: preoperatively

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)	7.0 score on a scale Interval 5.0 to 8.0	7.0 score on a scale Interval 6.0 to 8.0

SECONDARY outcome

Timeframe: 1 hour after arrival to PACU

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)	1.0 score on a scale Interval 0.0 to 3.75	1.0 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 8 hours

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)	2.0 score on a scale Interval 0.0 to 4.75	3.0 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 24 hours

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)	2.0 score on a scale Interval 1.0 to 3.5	1.0 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 36 hours

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)	3.0 score on a scale Interval 1.0 to 4.0	2.0 score on a scale Interval 0.75 to 3.0

SECONDARY outcome

Timeframe: 48 hours

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)	2.0 score on a scale Interval 1.0 to 3.0	2.0 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 24 hours

Population: Only completed participants are included.

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.

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Subject Satisfaction at 24 Hours	9 score on a scale Interval 8.0 to 10.0	9 score on a scale Interval 8.0 to 10.0

SECONDARY outcome

Timeframe: 48 hours

Population: Only completed participants are included.

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.

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Subject Satisfaction at 48 Hours (48 Hours)	9 score on a scale Interval 8.0 to 10.0	9 score on a scale Interval 9.0 to 10.0

SECONDARY outcome

Timeframe: Postoperative day 1

Population: Only completed participants are included.

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.

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Straight Leg Raise	16 Participants	11 Participants

SECONDARY outcome

Timeframe: Postoperative day 1

Population: Only completed participants are included.

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.

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Heel Slide Test	25 Participants	16 Participants

SECONDARY outcome

Timeframe: Postoperative day 1

Population: Only completed participants are included.

Number of participants able to go from supine to a sitting position independently.

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Number of Participants Able to Complete the Supine to Sit Test	10 Participants	6 Participants

SECONDARY outcome

Timeframe: Postoperative day 1

Population: Only completed participants are included.

Time taken to walk down a hallway 20 m at a safe and quick pace, turn around and return to starting point.

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Self-paced Walk Test	86 seconds Interval 41.0 to 1641.0	63 seconds Interval 43.0 to 1328.0

SECONDARY outcome

Timeframe: 0-72 hours

Population: Only completed participants are included.

Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Number of Participants With Opioid-related Adverse Events	15 participants	7 participants

SECONDARY outcome

Timeframe: day 30

morphine equivalent units of oral opioids and other non-opioids

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Analgesic Consumption as Measured by Patient Diary	0 mg Interval 0.0 to 0.0	0 mg Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: day 30

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Worst Pain (Day 30)	1.0 score on a scale Interval 0.0 to 2.0	0 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: preoperatively

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)	1.0 score on a scale Interval 0.0 to 4.0	2.0 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 1 hour after arrival to PACU

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)	2.0 score on a scale Interval 0.0 to 4.75	2.0 score on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 8 hours

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)	3.0 score on a scale Interval 1.0 to 5.0	5.5 score on a scale Interval 3.75 to 7.25

SECONDARY outcome

Timeframe: 24 hours

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)	5.0 score on a scale Interval 3.0 to 7.5	4.0 score on a scale Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 36 hours

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)	5.0 score on a scale Interval 3.0 to 70.0	4.5 score on a scale Interval 3.75 to 6.0

SECONDARY outcome

Timeframe: 48 hours

Population: Only completed participants are included.

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.

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Subject Satisfaction at 48 Hours	9 score on a scale Interval 8.0 to 10.0	9 score on a scale Interval 9.0 to 10.0

SECONDARY outcome

Timeframe: 48 hours

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).

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)	5.0 score on a scale Interval 3.0 to 6.0	5.0 score on a scale Interval 2.5 to 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-72 hours

Population: Only completed participants are included.

Time to both discharge readiness and to actual discharge

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Hospital Length of Stay	1 days Interval 1.0 to 2.0	1 days Interval 1.0 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-72 hours

difference in total hospital admission cost between groups

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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 Hospital Admission Costs	14682 US dollars Interval 13468.0 to 16353.0	14782 US dollars Interval 13461.0 to 17013.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-72 hours

difference in pharmacy-related cost between groups

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Pharmacy-related Costs	498 US dollars Interval 465.0 to 518.0	510 US dollars Interval 459.0 to 539.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-72 hours

difference in cost related to treatment of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) between groups

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Costs Related to Opioid-related Adverse Events	0.80 US dollars Standard Deviation 1.18	0.85 US dollars Standard Deviation 1.73

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-72 hours

mean cost (per patient) related to nursing care of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) in $USD

Outcome measures

Measure	Intravenous Acetaminophen n=31 Participants 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.	Oral Acetaminophen n=29 Participants 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.
Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events	1.86 US dollars Standard Deviation 2.68	1.82 US dollars Standard Deviation 3.50

Adverse Events

Intravenous Acetaminophen

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Oral Acetaminophen

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intravenous Acetaminophen n=31 participants at risk 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.	Oral Acetaminophen n=29 participants at risk 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.
Surgical and medical procedures Postoperative hematoma	0.00% 0/31 • 30 days	3.4% 1/29 • Number of events 1 • 30 days

Other adverse events

Measure	Intravenous Acetaminophen n=31 participants at risk 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.	Oral Acetaminophen n=29 participants at risk 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.
Gastrointestinal disorders Nausea	29.0% 9/31 • Number of events 10 • 30 days	10.3% 3/29 • Number of events 3 • 30 days
Gastrointestinal disorders constipation	9.7% 3/31 • Number of events 3 • 30 days	13.8% 4/29 • Number of events 4 • 30 days
Infections and infestations wound erythema/drainage	3.2% 1/31 • Number of events 1 • 30 days	10.3% 3/29 • Number of events 3 • 30 days
Cardiac disorders Dizziness/orthostasis	22.6% 7/31 • Number of events 7 • 30 days	3.4% 1/29 • Number of events 1 • 30 days
Musculoskeletal and connective tissue disorders Hip dislocation	0.00% 0/31 • 30 days	3.4% 1/29 • Number of events 1 • 30 days
Investigations Abnormal lab values (INR)	3.2% 1/31 • Number of events 1 • 30 days	0.00% 0/29 • 30 days
Nervous system disorders Polyneuropathy, peripheral	0.00% 0/31 • 30 days	3.4% 1/29 • Number of events 1 • 30 days
Skin and subcutaneous tissue disorders Pruritis	6.5% 2/31 • Number of events 2 • 30 days	0.00% 0/29 • 30 days
Infections and infestations Fever	3.2% 1/31 • Number of events 1 • 30 days	0.00% 0/29 • 30 days

Additional Information

Dr. Jeff Gadsden

Duke University Medical Center

Phone: 919-681-6437

Email: jeff.gadsden@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place