Trial Outcomes & Findings for PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement (NCT NCT02244619)
NCT ID: NCT02244619
Last Updated: 2017-07-24
Results Overview
Post-operative use of opioids, measured in morphine milligram equivalent (MME) units
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
515 participants
Primary outcome timeframe
During post-op period up to 24 hrs after surgery
Results posted on
2017-07-24
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
266
|
|
Overall Study
COMPLETED
|
241
|
245
|
|
Overall Study
NOT COMPLETED
|
8
|
21
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
Did not receive study intervention
|
8
|
21
|
Baseline Characteristics
PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement
Baseline characteristics by cohort
| Measure |
Oral Acetaminophen
n=241 Participants
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.
|
IV Acetaminophen
n=245 Participants
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
n=486 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
n=5 Participants
|
67.0 years
n=7 Participants
|
67.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
237 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
477 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 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
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
234 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
464 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Taking medications for chronic pain
|
214 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
426 Participants
n=5 Participants
|
|
Oxford score (hip or knee as appropriate)
|
20.76 units on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
20.19 units on a scale
STANDARD_DEVIATION 7.8 • n=7 Participants
|
20.47 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Body mass index
|
31.9 lb/in^2x703
n=5 Participants
|
32.3 lb/in^2x703
n=7 Participants
|
32.1 lb/in^2x703
n=5 Participants
|
|
Diabetes
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Stroke
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Type of surgery
Knee
|
168 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Type of surgery
Hip
|
73 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Pre-operative opioid
|
50 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Pre-operative Celecoxib
|
198 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Pre-operative Pregabalin
|
230 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
462 Participants
n=5 Participants
|
|
Intra-operative total opioid
|
10.0 morphine milligram equivalents (MME)
n=5 Participants
|
10.0 morphine milligram equivalents (MME)
n=7 Participants
|
10.0 morphine milligram equivalents (MME)
n=5 Participants
|
|
Intra-operative Ketorolac
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Intra-operative Bupivacaine Liposome Injectable Suspension
|
163 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
325 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During post-op period up to 24 hrs after surgeryPost-operative use of opioids, measured in morphine milligram equivalent (MME) units
Outcome measures
| Measure |
Oral Acetaminophen
n=241 Participants
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.
|
IV Acetaminophen
n=245 Participants
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.
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|---|---|---|
|
Total Post-operative Use of Opioids
|
21.7 Morphine milligram equivalents (MME)
Interval 12.5 to 33.6
|
21.7 Morphine milligram equivalents (MME)
Interval 11.3 to 34.4
|
SECONDARY outcome
Timeframe: Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgeryPatient-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.
Outcome measures
| Measure |
Oral Acetaminophen
n=241 Participants
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.
|
IV Acetaminophen
n=245 Participants
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.
|
|---|---|---|
|
Patient-rated Pain in the Post-operative Period
|
3.6 Visual analog pain scale (0-10)
Interval 2.4 to 5.0
|
3.4 Visual analog pain scale (0-10)
Interval 2.1 to 4.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During post-op period up to 24 hrs after surgeryOutcome measures
| Measure |
Oral Acetaminophen
n=241 Participants
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.
|
IV Acetaminophen
n=245 Participants
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.
|
|---|---|---|
|
Post-operative Nausea and Vomiting
Nausea
|
51 Participants
|
53 Participants
|
|
Post-operative Nausea and Vomiting
Vomiting
|
19 Participants
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During post-op period up to 24 hours after surgeryOutcome measures
| Measure |
Oral Acetaminophen
n=241 Participants
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.
|
IV Acetaminophen
n=245 Participants
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.
|
|---|---|---|
|
Time to First Ambulation - 10 Feet
|
18.5 Hours
Interval 13.8 to 21.3
|
18.8 Hours
Interval 15.1 to 21.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During post-op period up to 24 hrs after surgeryOutcome measures
| Measure |
Oral Acetaminophen
n=241 Participants
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.
|
IV Acetaminophen
n=245 Participants
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.
|
|---|---|---|
|
Time to First Rescue Opioid (PRN Order)
|
38.0 Minutes
Interval 20.5 to 151.0
|
41.0 Minutes
Interval 19.0 to 151.0
|
POST_HOC outcome
Timeframe: PACU admission time until PACU discharge timePACU length of stay was calculated as (PACU discharge moment - PACU admit moment). PACU length of stay is reported in hours.
Outcome measures
| Measure |
Oral Acetaminophen
n=241 Participants
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.
|
IV Acetaminophen
n=245 Participants
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.
|
|---|---|---|
|
Post-Anesthesia Care Unit (PACU) Length of Stay, Hours
|
2.2 Hours
Interval 1.7 to 2.7
|
2.1 Hours
Interval 1.7 to 2.6
|
POST_HOC outcome
Timeframe: Pre-op admission to hospital dischargeTotal hospital length of stay was calculated as (hospital discharge moment - hospital admission moment). Hospital length of stay is reported in hours.
Outcome measures
| Measure |
Oral Acetaminophen
n=241 Participants
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.
|
IV Acetaminophen
n=245 Participants
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.
|
|---|---|---|
|
Hospital Length of Stay (LOS)
|
58.0 Hours
Interval 55.6 to 79.6
|
58.5 Hours
Interval 55.5 to 80.9
|
Adverse Events
Oral Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place