KHEA: PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement

• Sponsor: Kettering Health Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT02244619
• Collaborator: (none)
• Enrollment: 515
• Location: 1
• Arms: 2
• Actual Duration (Months): 19
• Patients Per Site Per Month: 27.1

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen

Condition or Disease	Intervention/Treatment	Phase
Post-op Pain	Drug: Oral acetaminophen; Drug: IV acetaminophen	Phase 4

Detailed Description

Subjects will be randomized to receive perioperative dosing of either:

1. Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR,

2. IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules).

Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 515 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Randomized, Double-Blind, Study Comparing Oral Acetaminophen Plus Intravenous (IV) Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral acetaminophen Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.	Drug: Oral acetaminophen; Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.; Other Names: Tylenol
Active Comparator: IV acetaminophen Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.	Drug: IV acetaminophen; Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.; Other Names: Ofirmev

Outcome Measures

Primary Outcome Measures

1. Total Post-operative Use of Opioids [During post-op period up to 24 hrs after surgery]

   Post-operative use of opioids, measured in morphine milligram equivalent (MME) units

Secondary Outcome Measures

1. Patient-rated Pain in the Post-operative Period [Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery]

   Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.

Other Outcome Measures

1. Post-operative Nausea and Vomiting [During post-op period up to 24 hrs after surgery]

2. Time to First Ambulation - 10 Feet [During post-op period up to 24 hours after surgery]

3. Time to First Rescue Opioid (PRN Order) [During post-op period up to 24 hrs after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age and older

• Able to provide written consent

• Able to read and write in English

• Weighing over 50 kg

• Will undergo total hip or total knee joint replacement

Exclusion Criteria:

• Non-verbal patients

• Unable to use numeric pain scale

• Allergic to the test article

• Documented hepatic impairment or failure

• Current illicit drug use

• Requires traumatic or emergent surgery

• Pregnant women

• Women who are breastfeeding

• Prisoners

• Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)

• Unable to swallow oral capsules

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kettering Medical Center	Kettering	Ohio	United States	45429

Sponsors and Collaborators

• Kettering Health Network

Investigators

• Principal Investigator: Sidney (Skip) Hickman, RPh, Kettering Health Network

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kettering Health Network
• ClinicalTrials.gov Identifier: NCT02244619
• Other Study ID Numbers: KMCPH-13-001
• First Posted: Sep 19, 2014
• Last Update Posted: Jul 24, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Kettering Health Network: Hip replacement; Knee replacement; randomized trial; acetaminophen; post-op pain management
• Additional relevant MeSH terms: Pain, Postoperative; Acetaminophen

Study Results

Participant Flow

Arm/Group Title	Oral Acetaminophen	IV Acetaminophen
Arm/Group Description	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.	Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Period Title: Overall Study
STARTED	249	266
COMPLETED	241	245
NOT COMPLETED	8	21

Baseline Characteristics

Arm/Group Title	Oral Acetaminophen	IV Acetaminophen	Total
Arm/Group Description	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.	Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.	Total of all reporting groups
Overall Participants	241	245	486
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	67.0	67.0	67.0
Sex: Female, Male (Count of Participants)
Female	148 61.4%	140 57.1%	288 59.3%
Male	93 38.6%	105 42.9%	198 40.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 0.8%	5 2%	7 1.4%
Not Hispanic or Latino	237 98.3%	240 98%	477 98.1%
Unknown or Not Reported	2 0.8%	0 0%	2 0.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.8%	0 0%	2 0.4%
Asian	0 0%	3 1.2%	3 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 1.2%	11 4.5%	14 2.9%
White	234 97.1%	230 93.9%	464 95.5%
More than one race	0 0%	1 0.4%	1 0.2%
Unknown or Not Reported	2 0.8%	0 0%	2 0.4%
Taking medications for chronic pain (Count of Participants)
Count of Participants [Participants]	214 88.8%	212 86.5%	426 87.7%
Oxford score (hip or knee as appropriate) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	20.76 (7.5)	20.19 (7.8)	20.47 (7.6)
Body mass index (lb/in^2x703) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [lb/in^2x703]	31.9	32.3	32.1
Diabetes (Count of Participants)
Count of Participants [Participants]	48 19.9%	50 20.4%	98 20.2%
Stroke (Count of Participants)
Count of Participants [Participants]	5 2.1%	4 1.6%	9 1.9%
Type of surgery (Count of Participants)
Knee	168 69.7%	170 69.4%	338 69.5%
Hip	73 30.3%	75 30.6%	148 30.5%
Pre-operative opioid (Count of Participants)
Count of Participants [Participants]	50 20.7%	57 23.3%	107 22%
Pre-operative Celecoxib (Count of Participants)
Count of Participants [Participants]	198 82.2%	195 79.6%	393 80.9%
Pre-operative Pregabalin (Count of Participants)
Count of Participants [Participants]	230 95.4%	232 94.7%	462 95.1%
Intra-operative total opioid (morphine milligram equivalents (MME)) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [morphine milligram equivalents (MME)]	10.0	10.0	10.0
Intra-operative Ketorolac (Count of Participants)
Count of Participants [Participants]	35 14.5%	36 14.7%	71 14.6%
Intra-operative Bupivacaine Liposome Injectable Suspension (Count of Participants)
Count of Participants [Participants]	163 67.6%	162 66.1%	325 66.9%

Outcome Measures

1. Primary Outcome

Title	Total Post-operative Use of Opioids
Description	Post-operative use of opioids, measured in morphine milligram equivalent (MME) units
Time Frame	During post-op period up to 24 hrs after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Acetaminophen	IV Acetaminophen
Arm/Group Description	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.	Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Measure Participants	241	245
Median (Inter-Quartile Range) [Morphine milligram equivalents (MME)]	21.7	21.7

2. Secondary Outcome

Title	Patient-rated Pain in the Post-operative Period
Description	Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.
Time Frame	Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Acetaminophen	IV Acetaminophen
Arm/Group Description	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.	Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Measure Participants	241	245
Median (Inter-Quartile Range) [Visual analog pain scale (0-10)]	3.6	3.4

3. Other Pre-specified Outcome

Title	Post-operative Nausea and Vomiting
Time Frame	During post-op period up to 24 hrs after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Acetaminophen	IV Acetaminophen
Arm/Group Description	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.	Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Measure Participants	241	245
Nausea	51 21.2%	53 21.6%
Vomiting	19 7.9%	17 6.9%

4. Other Pre-specified Outcome

Title	Time to First Ambulation - 10 Feet
Time Frame	During post-op period up to 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Acetaminophen	IV Acetaminophen
Arm/Group Description	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.	Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Measure Participants	241	245
Median (Inter-Quartile Range) [Hours]	18.5	18.8

5. Other Pre-specified Outcome

Title	Time to First Rescue Opioid (PRN Order)
Time Frame	During post-op period up to 24 hrs after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Acetaminophen	IV Acetaminophen
Arm/Group Description	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.	Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Measure Participants	241	245
Median (Inter-Quartile Range) [Minutes]	38.0	41.0

6. Post-Hoc Outcome

Title	Post-Anesthesia Care Unit (PACU) Length of Stay, Hours
Description	PACU length of stay was calculated as (PACU discharge moment - PACU admit moment). PACU length of stay is reported in hours.
Time Frame	PACU admission time until PACU discharge time

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Acetaminophen	IV Acetaminophen
Arm/Group Description	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.	Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Measure Participants	241	245
Median (Inter-Quartile Range) [Hours]	2.2	2.1

7. Post-Hoc Outcome

Title	Hospital Length of Stay (LOS)
Description	Total hospital length of stay was calculated as (hospital discharge moment - hospital admission moment). Hospital length of stay is reported in hours.
Time Frame	Pre-op admission to hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Acetaminophen	IV Acetaminophen
Arm/Group Description	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.	Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Measure Participants	241	245
Median (Inter-Quartile Range) [Hours]	58.0	58.5

Adverse Events

Time Frame	AE/SAE monitoring started at first study drug dose and ended when subjects were discharged from the Post-Anesthesia Care Unit. The time period varied among subjects but was never more than 24 hours total.
Adverse Event Reporting Description	Since both the PO and IV forms of the study drug are FDA approved, both are being used within approved labeling, and the study is not being conducted under an Investigational New Drug (IND) application, only events that meet Kettering Health Network's criteria for reporting within the institution's S.A.F.E. reporting system will be reported as SAEs or UPs.
Arm/Group Title	Oral Acetaminophen		IV Acetaminophen
Arm/Group Description	Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.		Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
All Cause Mortality
	Oral Acetaminophen		IV Acetaminophen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/241 (0%)		0/245 (0%)
Serious Adverse Events
	Oral Acetaminophen		IV Acetaminophen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/241 (0%)		0/245 (0%)
Other (Not Including Serious) Adverse Events
	Oral Acetaminophen		IV Acetaminophen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/241 (0%)		0/245 (0%)

Limitations/Caveats

Single hospital, limited to two types of surgical patient. No standard protocol for assessing pain. Oral acetaminophen administered earlier than IV per hospital protocol.

More Information

Certain Agreements

All Principal Investigators ARE 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.