Trial Outcomes & Findings for Opioid Analgesic Reduction Study (NCT NCT04452344)
NCT ID: NCT04452344
Last Updated: 2026-08-31
Results Overview
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
COMPLETED
PHASE3
1815 participants
End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery
2026-08-31
Participant Flow
Participant milestones
| Measure |
Non-Opioid
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Overall Study
STARTED
|
909
|
906
|
|
Overall Study
COMPLETED
|
897
|
889
|
|
Overall Study
NOT COMPLETED
|
12
|
17
|
Reasons for withdrawal
| Measure |
Non-Opioid
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
No Post-Op Visit
|
6
|
7
|
Baseline Characteristics
Opioid Analgesic Reduction Study
Baseline characteristics by cohort
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
Total
n=1815 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
25.58 Years
STANDARD_DEVIATION 5.97 • n=14 Participants
|
25.81 Years
STANDARD_DEVIATION 6.50 • n=36 Participants
|
25.69 Years
STANDARD_DEVIATION 6.24 • n=324 Participants
|
|
Sex: Female, Male
Female
|
457 Participants
n=14 Participants
|
453 Participants
n=36 Participants
|
910 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
452 Participants
n=14 Participants
|
453 Participants
n=36 Participants
|
905 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
279 Participants
n=14 Participants
|
282 Participants
n=36 Participants
|
561 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Asian
|
141 Participants
n=14 Participants
|
131 Participants
n=36 Participants
|
272 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
255 Participants
n=14 Participants
|
257 Participants
n=36 Participants
|
512 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
179 Participants
n=14 Participants
|
178 Participants
n=36 Participants
|
357 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
Other
|
32 Participants
n=14 Participants
|
30 Participants
n=36 Participants
|
62 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
Did Not Want to Report
|
23 Participants
n=14 Participants
|
28 Participants
n=36 Participants
|
51 Participants
n=324 Participants
|
|
3rd molars extracted
|
2.75 teeth
STANDARD_DEVIATION 1.17 • n=14 Participants
|
2.75 teeth
STANDARD_DEVIATION 1.21 • n=36 Participants
|
2.75 teeth
STANDARD_DEVIATION 1.19 • n=324 Participants
|
|
Impacted full bony 3rd molars extracted
|
.96 teeth
STANDARD_DEVIATION 1.23 • n=14 Participants
|
0.98 teeth
STANDARD_DEVIATION 1.22 • n=36 Participants
|
.97 teeth
STANDARD_DEVIATION 1.23 • n=324 Participants
|
PRIMARY outcome
Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)Population: Subgroup data has been included
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain 1
|
3.77 units on a scale
Interval 3.58 to 3.96
|
4.47 units on a scale
Interval 4.28 to 4.65
|
PRIMARY outcome
Timeframe: End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain 2
|
3.20 units on a scale
Interval 3.01 to 3.39
|
3.48 units on a scale
Interval 3.29 to 3.67
|
PRIMARY outcome
Timeframe: End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain 3
|
2.97 units on a scale
Interval 2.78 to 3.16
|
3.06 units on a scale
Interval 2.87 to 3.25
|
PRIMARY outcome
Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain All
|
2.73 units on a scale
Interval 2.54 to 2.92
|
2.94 units on a scale
Interval 2.74 to 3.13
|
PRIMARY outcome
Timeframe: At time of post-operative visit (day 9 +/- 5 days)Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: "Overall, how satisfied were you with your current pain medication?"
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Overall Satisfaction
Very Satisfied
|
355 Participants
|
308 Participants
|
|
Overall Satisfaction
Satisfied
|
409 Participants
|
395 Participants
|
|
Overall Satisfaction
Neither satisfied nor dissatisfied
|
87 Participants
|
122 Participants
|
|
Overall Satisfaction
Dissatisfied
|
33 Participants
|
54 Participants
|
|
Overall Satisfaction
Very dissatisfied
|
12 Participants
|
12 Participants
|
|
Overall Satisfaction
MIssing
|
13 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst 1
|
4.90 score on a scale
Interval 4.59 to 5.21
|
5.79 score on a scale
Interval 5.47 to 6.1
|
PRIMARY outcome
Timeframe: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgeryParticipants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst 2
|
4.17 score on a scale
Interval 3.86 to 4.48
|
4.48 score on a scale
Interval 4.17 to 4.8
|
PRIMARY outcome
Timeframe: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst 3
|
3.97 score on a scale
Interval 3.65 to 4.28
|
3.96 score on a scale
Interval 3.65 to 4.27
|
PRIMARY outcome
Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst All
|
3.66 score on a scale
Interval 3.34 to 3.97
|
3.79 score on a scale
Interval 3.48 to 4.11
|
PRIMARY outcome
Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average 1
|
3.75 score on a scale
Interval 3.57 to 3.94
|
4.47 score on a scale
Interval 4.29 to 4.66
|
PRIMARY outcome
Timeframe: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average 2
|
3.18 score on a scale
Interval 3.0 to 3.37
|
3.49 score on a scale
Interval 3.31 to 3.68
|
PRIMARY outcome
Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average All
|
2.69 score on a scale
Interval 2.5 to 2.88
|
2.95 score on a scale
Interval 2.76 to 3.14
|
PRIMARY outcome
Timeframe: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average 3
|
2.97 score on a scale
Interval 2.78 to 3.15
|
3.07 score on a scale
Interval 2.89 to 3.26
|
SECONDARY outcome
Timeframe: At post operative visit (9 days after surgery +/- 5 days)Participant receiving additional pain medication (oxycodone) as study analgesic is not managing pain sufficiently
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Number of Participants Receiving Rescue Medication
|
26 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: End of the day of surgery (day 1)Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 1 is the average ratings provided at the end of the day of surgery. Lower scores are better.
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Interference 1
|
2.75 score on a scale
Interval 2.65 to 2.85
|
3.11 score on a scale
Interval 3.01 to 3.21
|
SECONDARY outcome
Timeframe: End of the first full day after surgery (day 2)Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 2 is the average ratings provided at the end of day after surgery (day 2). Lower scores are better.
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Interference 2
|
2.27 score on a scale
Interval 2.17 to 2.37
|
2.50 score on a scale
Interval 2.4 to 2.59
|
SECONDARY outcome
Timeframe: End of the second full day after surgery (day 3)Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 3 is the average ratings provided at the end of 2nd day after surgery (day 3). Lower scores are better.
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Interference 3
|
2.20 score on a scale
Interval 2.1 to 2.3
|
2.34 score on a scale
Interval 2.24 to 2.44
|
SECONDARY outcome
Timeframe: First 7 days after surgeryParticipants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference ALL is the average ratings provided at the end of the 1st seven days after surgery (days 1 thru 7). Lower scores are better.
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Interference All
|
2.09 score on a scale
Interval 2.01 to 2.18
|
2.21 score on a scale
Interval 2.13 to 2.3
|
SECONDARY outcome
Timeframe: When first waking up the day after surgeryParticipants were asked to rate the overall quality of their sleep the 1st night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 1 is the rating provided when first waking up the day after surgery.
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Sleep 1
|
4.28 score on a scale
Interval 4.02 to 4.54
|
4.62 score on a scale
Interval 4.36 to 4.88
|
SECONDARY outcome
Timeframe: When first waking up the 2nd day after surgeryParticipants were asked to rate the overall quality of their sleep the 2nd night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 2 is the rating provided when first waking up the second day after surgery.
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Sleep 2
|
4.10 score on a scale
Interval 3.84 to 4.35
|
4.14 score on a scale
Interval 3.88 to 4.4
|
SECONDARY outcome
Timeframe: When first waking up the 3rd day after surgeryParticipants were asked to rate the overall quality of their sleep the 3rd night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 1 is the rating provided when first waking up the third day after surgery.
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Sleep 3
|
3.78 score on a scale
Interval 3.52 to 4.04
|
3.82 score on a scale
Interval 3.56 to 4.08
|
SECONDARY outcome
Timeframe: First 7 nights after surgeryParticipants were asked to rate the overall quality of their sleep for the first 7 nights after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep All is the average rating provided for all seven nights.
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Sleep All
|
3.69 score on a scale
Interval 3.44 to 3.94
|
3.62 score on a scale
Interval 3.37 to 3.87
|
SECONDARY outcome
Timeframe: At post operative visit (9 days after surgery +/- 5 days)Number of returned opioid analgesic capsules at post operative visit (9 days after surgery +/- 5 days)
Outcome measures
| Measure |
Non-Opioid
n=896 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=891 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Potential for Opioid Tablet Diversion
|
0 capsules
Interval 0.0 to 0.0
|
8.55 capsules
Interval 7.5 to 9.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 )Population: Data stratified by sex
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain 1 by Sex
Female
|
4.03 units on a scale
Interval 3.87 to 4.2
|
4.67 units on a scale
Interval 4.5 to 4.85
|
|
Composite Pain 1 by Sex
Male
|
3.47 units on a scale
Interval 3.32 to 3.61
|
4.21 units on a scale
Interval 4.04 to 4.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)Population: Data stratified by sex
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain 2 by Sex
Female
|
3.52 units on a scale
Interval 3.37 to 3.68
|
3.78 units on a scale
Interval 3.62 to 3.94
|
|
Composite Pain 2 by Sex
Male
|
2.82 units on a scale
Interval 2.68 to 2.97
|
3.07 units on a scale
Interval 2.92 to 3.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)Population: Data stratified by sex
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain 3 by Sex
Female
|
3.29 units on a scale
Interval 3.13 to 3.44
|
3.36 units on a scale
Interval 3.2 to 3.51
|
|
Composite Pain 3 by Sex
Male
|
2.58 units on a scale
Interval 2.44 to 2.72
|
2.66 units on a scale
Interval 2.51 to 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)Population: Data stratified by sex
NIH Required Analysis - Description Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain All by Sex
Male
|
2.37 units on a scale
Interval 2.32 to 2.43
|
2.50 units on a scale
Interval 2.44 to 2.56
|
|
Composite Pain All by Sex
Female
|
2.98 units on a scale
Interval 2.92 to 3.04
|
3.08 units on a scale
Interval 3.02 to 3.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of post-operative visit (day 9 +/- 5 days)Population: Data stratified by sex
NIH Required Analysis - Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: "Overall, how satisfied were you with your current pain medication?"
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Overall Satisfaction by Sex
Female · Very Satisfied
|
168 Participants
|
145 Participants
|
|
Overall Satisfaction by Sex
Female · Satisfied
|
207 Participants
|
194 Participants
|
|
Overall Satisfaction by Sex
Female · Neither satisfied nor dissatisfied
|
46 Participants
|
68 Participants
|
|
Overall Satisfaction by Sex
Female · Dissatisfied
|
25 Participants
|
30 Participants
|
|
Overall Satisfaction by Sex
Female · Very dissatisfied
|
7 Participants
|
8 Participants
|
|
Overall Satisfaction by Sex
Female · Missing
|
4 Participants
|
8 Participants
|
|
Overall Satisfaction by Sex
Male · Very Satisfied
|
187 Participants
|
163 Participants
|
|
Overall Satisfaction by Sex
Male · Satisfied
|
202 Participants
|
201 Participants
|
|
Overall Satisfaction by Sex
Male · Neither satisfied nor dissatisfied
|
41 Participants
|
54 Participants
|
|
Overall Satisfaction by Sex
Male · Dissatisfied
|
8 Participants
|
24 Participants
|
|
Overall Satisfaction by Sex
Male · Very dissatisfied
|
5 Participants
|
4 Participants
|
|
Overall Satisfaction by Sex
Male · Missing
|
9 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)Population: Data stratified by sex
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst 1 by Sex
Female
|
5.08 units on a scale
Interval 4.89 to 5.27
|
5.99 units on a scale
Interval 5.8 to 6.18
|
|
Pain Worst 1 by Sex
Male
|
4.66 units on a scale
Interval 4.48 to 4.84
|
5.51 units on a scale
Interval 5.32 to 5.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)Population: Data stratified by sex
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst 2 by Sex
Female
|
4.46 units on a scale
Interval 4.28 to 4.63
|
4.78 units on a scale
Interval 4.61 to 4.96
|
|
Pain Worst 2 by Sex
Male
|
3.81 units on a scale
Interval 3.64 to 3.98
|
4.05 units on a scale
Interval 3.87 to 4.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: e End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)Population: Data stratified by sex
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst 3 by Sex
Female
|
4.26 units on a scale
Interval 4.09 to 4.44
|
4.25 units on a scale
Interval 4.07 to 4.43
|
|
Pain Worst 3 by Sex
Male
|
3.59 units on a scale
Interval 3.41 to 3.76
|
3.52 units on a scale
Interval 3.35 to 3.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)Population: Data stratified by sex
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst All by Sex
Female
|
3.86 score on a scale
Interval 3.79 to 3.93
|
3.95 score on a scale
Interval 3.88 to 4.03
|
|
Pain Worst All by Sex
Male
|
3.28 score on a scale
Interval 3.21 to 3.35
|
3.33 score on a scale
Interval 3.26 to 3.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)Population: Data stratified by sex
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average 1 by Sex
Female
|
3.99 units on a scale
Interval 3.81 to 4.16
|
4.67 units on a scale
Interval 4.49 to 4.86
|
|
Pain Average 1 by Sex
Male
|
3.48 units on a scale
Interval 3.32 to 3.64
|
4.23 units on a scale
Interval 4.05 to 4.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)Population: Data stratified by sex
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average 2 by Sex
Female
|
3.52 score on a scale
Interval 3.36 to 3.68
|
3.83 score on a scale
Interval 3.66 to 4.0
|
|
Pain Average 2 by Sex
Male
|
2.79 score on a scale
Interval 2.64 to 2.93
|
3.05 score on a scale
Interval 2.9 to 3.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)Population: Data stratified by sex
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average 3 by Sex
Female
|
3.30 score on a scale
Interval 3.14 to 3.46
|
3.40 score on a scale
Interval 3.23 to 3.56
|
|
Pain Average 3 by Sex
Male
|
2.56 score on a scale
Interval 2.41 to 2.7
|
2.64 score on a scale
Interval 2.49 to 2.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)Population: Data analysis stratified by sex
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average All by Sex
Female
|
2.97 score on a scale
Interval 2.91 to 3.04
|
3.09 score on a scale
Interval 3.02 to 3.16
|
|
Pain Average All by Sex
Male
|
2.35 score on a scale
Interval 2.29 to 2.4
|
2.49 score on a scale
Interval 2.42 to 2.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 )Population: Data stratified by race and ethnicity
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain 1 by Race Ethnicity
Non-Hispanic Black
|
4.17 units on a scale
Interval 3.94 to 4.41
|
4.96 units on a scale
Interval 4.72 to 5.21
|
|
Composite Pain 1 by Race Ethnicity
Non-Hispanic White
|
3.86 units on a scale
Interval 3.64 to 4.07
|
4.43 units on a scale
Interval 4.19 to 4.67
|
|
Composite Pain 1 by Race Ethnicity
Non-Hispanic Asian
|
2.76 units on a scale
Interval 2.53 to 3.0
|
3.72 units on a scale
Interval 3.43 to 4.01
|
|
Composite Pain 1 by Race Ethnicity
Hispanic
|
3.74 units on a scale
Interval 3.54 to 3.94
|
4.31 units on a scale
Interval 4.09 to 4.52
|
|
Composite Pain 1 by Race Ethnicity
Other
|
4.39 units on a scale
Interval 3.77 to 5.01
|
4.74 units on a scale
Interval 4.1 to 5.38
|
|
Composite Pain 1 by Race Ethnicity
Do Not Want to Report
|
3.99 units on a scale
Interval 3.24 to 4.73
|
4.32 units on a scale
Interval 3.56 to 5.08
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)Population: Data stratified by race and ethnicity
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain 2 by Race Ethnicity
Non-Hispanic Black
|
3.39 units on a scale
Interval 3.16 to 3.62
|
3.68 units on a scale
Interval 3.45 to 3.91
|
|
Composite Pain 2 by Race Ethnicity
Non-Hispanic White
|
3.31 units on a scale
Interval 3.08 to 3.54
|
3.54 units on a scale
Interval 3.31 to 3.76
|
|
Composite Pain 2 by Race Ethnicity
Non-Hispanic Asian
|
2.45 units on a scale
Interval 2.24 to 2.67
|
2.69 units on a scale
Interval 2.43 to 2.95
|
|
Composite Pain 2 by Race Ethnicity
Hispanic
|
3.26 units on a scale
Interval 3.07 to 3.45
|
3.43 units on a scale
Interval 3.23 to 3.62
|
|
Composite Pain 2 by Race Ethnicity
Other
|
3.51 units on a scale
Interval 2.89 to 4.13
|
3.75 units on a scale
Interval 3.1 to 4.39
|
|
Composite Pain 2 by Race Ethnicity
Do Not Want to Report
|
3.07 units on a scale
Interval 2.43 to 3.7
|
3.66 units on a scale
Interval 2.98 to 4.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)Population: data stratified by race and ethnicity
NIH Required Analysis - Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain 3 by Race Ethnicity
Non-Hispanic Black
|
3.20 units on a scale
Interval 2.97 to 3.43
|
3.24 units on a scale
Interval 3.02 to 3.46
|
|
Composite Pain 3 by Race Ethnicity
Non-Hispanic White
|
2.97 units on a scale
Interval 2.75 to 3.19
|
3.13 units on a scale
Interval 2.91 to 3.35
|
|
Composite Pain 3 by Race Ethnicity
Non-Hispanic Asian
|
2.35 units on a scale
Interval 2.13 to 2.57
|
2.26 units on a scale
Interval 2.02 to 2.51
|
|
Composite Pain 3 by Race Ethnicity
Hispanic
|
2.98 units on a scale
Interval 2.79 to 3.17
|
3.08 units on a scale
Interval 2.87 to 3.28
|
|
Composite Pain 3 by Race Ethnicity
Other
|
3.21 units on a scale
Interval 2.61 to 3.81
|
3.21 units on a scale
Interval 2.57 to 3.86
|
|
Composite Pain 3 by Race Ethnicity
Do Not Want to Report
|
2.76 units on a scale
Interval 2.14 to 3.38
|
2.69 units on a scale
Interval 2.15 to 3.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)Population: Data stratified by race and ethnicity
NIH Required Analysis - Description Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Composite Pain All by Race and Ethnicity
Non-Hispanic Black
|
3.06 units on a scale
Interval 2.97 to 3.15
|
3.11 units on a scale
Interval 3.02 to 3.2
|
|
Composite Pain All by Race and Ethnicity
Non-Hispanic White
|
2.72 units on a scale
Interval 2.64 to 2.81
|
2.87 units on a scale
Interval 2.78 to 2.97
|
|
Composite Pain All by Race and Ethnicity
Non-Hispanic Asian
|
2.03 units on a scale
Interval 1.95 to 2.11
|
2.12 units on a scale
Interval 2.02 to 2.22
|
|
Composite Pain All by Race and Ethnicity
Hispanic
|
2.63 units on a scale
Interval 2.55 to 2.7
|
2.76 units on a scale
Interval 2.68 to 2.85
|
|
Composite Pain All by Race and Ethnicity
Other
|
3.03 units on a scale
Interval 2.79 to 3.27
|
3.02 units on a scale
Interval 2.76 to 3.27
|
|
Composite Pain All by Race and Ethnicity
Do Not Want to Report
|
2.62 units on a scale
Interval 2.38 to 2.85
|
2.73 units on a scale
Interval 2.46 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of post-operative visit (day 9 +/- 5 days)Population: Data stratified by race and ethnicity
NIH Required Analysis - Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: "Overall, how satisfied were you with your current pain medication?"
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic White · Satisfied
|
93 Participants
|
73 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Black · Very Satisfied
|
89 Participants
|
86 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Black · Satisfied
|
107 Participants
|
117 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Black · Neither Satisfied or Dissatisfied
|
35 Participants
|
30 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Black · Dissatisfied
|
13 Participants
|
14 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Black · Very Dissatisfied
|
5 Participants
|
2 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Black · Did not report
|
6 Participants
|
8 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic White · Very Satisfied
|
62 Participants
|
55 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic White · Neither Satisfied or Dissatisfied
|
13 Participants
|
28 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic White · Dissatisfied
|
6 Participants
|
17 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic White · Very Dissatisfied
|
3 Participants
|
4 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic White · Did not report
|
2 Participants
|
1 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Asian · Very Satisfied
|
66 Participants
|
42 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Asian · Satisfied
|
60 Participants
|
59 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Asian · Neither Satisfied or Dissatisfied
|
10 Participants
|
24 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Asian · Dissatisfied
|
3 Participants
|
2 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Asian · Very Dissatisfied
|
0 Participants
|
1 Participants
|
|
Overall Satisfaction by Race Ethnicity
Non-Hispanic Asian · Did not report
|
2 Participants
|
3 Participants
|
|
Overall Satisfaction by Race Ethnicity
Hispanic · Very Satisfied
|
114 Participants
|
109 Participants
|
|
Overall Satisfaction by Race Ethnicity
Hispanic · Satisfied
|
126 Participants
|
120 Participants
|
|
Overall Satisfaction by Race Ethnicity
Hispanic · Neither Satisfied or Dissatisfied
|
24 Participants
|
31 Participants
|
|
Overall Satisfaction by Race Ethnicity
Hispanic · Dissatisfied
|
10 Participants
|
16 Participants
|
|
Overall Satisfaction by Race Ethnicity
Hispanic · Very Dissatisfied
|
3 Participants
|
4 Participants
|
|
Overall Satisfaction by Race Ethnicity
Hispanic · Did not report
|
2 Participants
|
2 Participants
|
|
Overall Satisfaction by Race Ethnicity
Other · Very Satisfied
|
14 Participants
|
12 Participants
|
|
Overall Satisfaction by Race Ethnicity
Other · Satisfied
|
13 Participants
|
9 Participants
|
|
Overall Satisfaction by Race Ethnicity
Other · Neither Satisfied or Dissatisfied
|
3 Participants
|
4 Participants
|
|
Overall Satisfaction by Race Ethnicity
Other · Dissatisfied
|
0 Participants
|
4 Participants
|
|
Overall Satisfaction by Race Ethnicity
Other · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Overall Satisfaction by Race Ethnicity
Other · Did not report
|
1 Participants
|
1 Participants
|
|
Overall Satisfaction by Race Ethnicity
Do Not Want to Report · Very Satisfied
|
10 Participants
|
4 Participants
|
|
Overall Satisfaction by Race Ethnicity
Do Not Want to Report · Satisfied
|
10 Participants
|
17 Participants
|
|
Overall Satisfaction by Race Ethnicity
Do Not Want to Report · Neither Satisfied or Dissatisfied
|
2 Participants
|
5 Participants
|
|
Overall Satisfaction by Race Ethnicity
Do Not Want to Report · Dissatisfied
|
1 Participants
|
1 Participants
|
|
Overall Satisfaction by Race Ethnicity
Do Not Want to Report · Very Dissatisfied
|
0 Participants
|
1 Participants
|
|
Overall Satisfaction by Race Ethnicity
Do Not Want to Report · Did not report
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)Population: Subgroup analysis
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst 1 by Race Ethnicity
Non-Hispanice Black
|
5.08 units on a scale
Interval 4.81 to 5.34
|
6.08 units on a scale
Interval 5.8 to 6.36
|
|
Pain Worst 1 by Race Ethnicity
Non-Hispanic White
|
5.40 units on a scale
Interval 5.13 to 5.67
|
6.14 units on a scale
Interval 5.87 to 6.41
|
|
Pain Worst 1 by Race Ethnicity
Non-Hispanic Asian
|
3.97 units on a scale
Interval 3.67 to 4.27
|
5.25 units on a scale
Interval 4.91 to 5.58
|
|
Pain Worst 1 by Race Ethnicity
Hispanic
|
4.69 units on a scale
Interval 4.45 to 4.92
|
5.42 units on a scale
Interval 5.18 to 5.66
|
|
Pain Worst 1 by Race Ethnicity
Other
|
5.63 units on a scale
Interval 4.94 to 6.31
|
6.19 units on a scale
Interval 5.56 to 6.83
|
|
Pain Worst 1 by Race Ethnicity
Do Not Want to Report
|
5.48 units on a scale
Interval 4.61 to 6.34
|
5.57 units on a scale
Interval 4.68 to 6.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)Population: Data stratified by race and ethnicity
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst 2 by Race Ethnicity
Non-Hispanic Black
|
4.13 units on a scale
Interval 3.88 to 4.38
|
4.49 units on a scale
Interval 4.23 to 4.75
|
|
Pain Worst 2 by Race Ethnicity
Non-Hispanic White
|
4.54 units on a scale
Interval 4.28 to 4.8
|
4.88 units on a scale
Interval 4.62 to 5.14
|
|
Pain Worst 2 by Race Ethnicity
Non-Hispanic Asian
|
3.50 units on a scale
Interval 3.22 to 3.78
|
3.85 units on a scale
Interval 3.53 to 4.16
|
|
Pain Worst 2 by Race Ethnicity
Hispanic
|
4.13 units on a scale
Interval 3.91 to 4.36
|
4.28 units on a scale
Interval 4.06 to 4.5
|
|
Pain Worst 2 by Race Ethnicity
Other
|
4.92 units on a scale
Interval 4.19 to 5.65
|
4.79 units on a scale
Interval 4.11 to 5.46
|
|
Pain Worst 2 by Race Ethnicity
Do Not Want to Report
|
4.17 units on a scale
Interval 3.44 to 4.9
|
4.65 units on a scale
Interval 3.9 to 5.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: e End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)Population: Data stratified by Race and Ethnicity
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst 3 by Race Ethnicity
Non-Hispanic Black
|
3.98 units on a scale
Interval 3.72 to 4.24
|
3.95 units on a scale
Interval 3.69 to 4.2
|
|
Pain Worst 3 by Race Ethnicity
Non-Hispanic White
|
4.21 units on a scale
Interval 3.94 to 4.47
|
4.41 units on a scale
Interval 4.14 to 4.67
|
|
Pain Worst 3 by Race Ethnicity
Non-Hispanic Asian
|
3.45 units on a scale
Interval 3.17 to 3.73
|
3.23 units on a scale
Interval 2.93 to 3.52
|
|
Pain Worst 3 by Race Ethnicity
Hispanic
|
3.90 units on a scale
Interval 3.67 to 4.13
|
3.83 units on a scale
Interval 3.6 to 4.07
|
|
Pain Worst 3 by Race Ethnicity
Other
|
4.52 units on a scale
Interval 3.8 to 5.24
|
4.05 units on a scale
Interval 3.36 to 4.74
|
|
Pain Worst 3 by Race Ethnicity
Do Not Want to Report
|
3.87 units on a scale
Interval 3.12 to 4.62
|
3.54 units on a scale
Interval 2.84 to 4.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)Population: Data stratified by race and ethnicity
NIH Required Analysis - Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Worst All by Race Ethnicity
Hispanic
|
3.39 score on a scale
Interval 3.3 to 3.48
|
3.48 score on a scale
Interval 3.38 to 3.57
|
|
Pain Worst All by Race Ethnicity
Non-Hispanic Black
|
3.79 score on a scale
Interval 3.69 to 3.9
|
3.85 score on a scale
Interval 3.74 to 3.95
|
|
Pain Worst All by Race Ethnicity
Non-Hispanic White
|
3.87 score on a scale
Interval 3.77 to 3.98
|
4.06 score on a scale
Interval 3.94 to 4.17
|
|
Pain Worst All by Race Ethnicity
Non-Hispanic Asian
|
3.04 score on a scale
Interval 2.93 to 3.15
|
3.02 score on a scale
Interval 2.9 to 3.15
|
|
Pain Worst All by Race Ethnicity
Other
|
4.18 score on a scale
Interval 3.89 to 4.47
|
3.89 score on a scale
Interval 3.61 to 4.18
|
|
Pain Worst All by Race Ethnicity
Do Not Want to Report
|
3.72 score on a scale
Interval 3.43 to 4.01
|
3.54 score on a scale
Interval 3.23 to 3.85
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)Population: Data satisfied by race and ethnicity
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average 1 by Race Ethnicity
Non-Hispanic Black
|
4.22 units on a scale
Interval 3.97 to 4.47
|
4.89 units on a scale
Interval 4.62 to 5.16
|
|
Pain Average 1 by Race Ethnicity
Non-Hispanic White
|
3.75 units on a scale
Interval 3.52 to 3.98
|
4.42 units on a scale
Interval 4.16 to 4.69
|
|
Pain Average 1 by Race Ethnicity
Non-Hispanic Asian
|
2.74 units on a scale
Interval 2.5 to 2.99
|
3.80 units on a scale
Interval 3.49 to 4.1
|
|
Pain Average 1 by Race Ethnicity
Hispanic
|
3.74 units on a scale
Interval 3.53 to 3.95
|
4.33 units on a scale
Interval 4.1 to 4.56
|
|
Pain Average 1 by Race Ethnicity
Other
|
4.27 units on a scale
Interval 3.61 to 4.92
|
4.91 units on a scale
Interval 4.2 to 5.63
|
|
Pain Average 1 by Race Ethnicity
Do Not Want to Report
|
3.88 units on a scale
Interval 3.04 to 4.71
|
4.53 units on a scale
Interval 3.73 to 5.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)Population: Data stratified by race and ethnicity
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average 2 by Race Ethnicity
Non-Hispanic White
|
3.16 score on a scale
Interval 2.93 to 3.39
|
3.46 score on a scale
Interval 3.22 to 3.69
|
|
Pain Average 2 by Race Ethnicity
Non-Hispanic Asian
|
2.38 score on a scale
Interval 2.16 to 2.6
|
2.62 score on a scale
Interval 2.35 to 2.89
|
|
Pain Average 2 by Race Ethnicity
Hispanic
|
3.29 score on a scale
Interval 3.09 to 3.48
|
3.46 score on a scale
Interval 3.26 to 3.66
|
|
Pain Average 2 by Race Ethnicity
Other
|
3.40 score on a scale
Interval 2.75 to 4.05
|
3.91 score on a scale
Interval 3.22 to 4.6
|
|
Pain Average 2 by Race Ethnicity
Do Not Want to Report
|
3.15 score on a scale
Interval 2.45 to 3.85
|
3.75 score on a scale
Interval 3.03 to 4.47
|
|
Pain Average 2 by Race Ethnicity
Non-Hispanic Black
|
3.45 score on a scale
Interval 3.21 to 3.68
|
3.76 score on a scale
Interval 3.52 to 3.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)Population: Data stratified by race and ethnicity
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average 3 by Race Ethnicity
Non-Hispanic Black
|
3.21 score on a scale
Interval 2.98 to 3.45
|
3.29 score on a scale
Interval 3.05 to 3.52
|
|
Pain Average 3 by Race Ethnicity
Non-Hispanic White
|
2.91 score on a scale
Interval 2.69 to 3.14
|
3.11 score on a scale
Interval 2.87 to 3.34
|
|
Pain Average 3 by Race Ethnicity
Non-Hispanic Asian
|
2.26 score on a scale
Interval 2.03 to 2.49
|
2.21 score on a scale
Interval 1.95 to 2.47
|
|
Pain Average 3 by Race Ethnicity
Hispanic
|
3.02 score on a scale
Interval 2.83 to 3.22
|
3.10 score on a scale
Interval 2.9 to 3.31
|
|
Pain Average 3 by Race Ethnicity
Other
|
3.27 score on a scale
Interval 2.67 to 3.88
|
3.31 score on a scale
Interval 2.63 to 3.99
|
|
Pain Average 3 by Race Ethnicity
Do Not Want to Report
|
2.85 score on a scale
Interval 2.18 to 3.52
|
2.65 score on a scale
Interval 2.07 to 3.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)Population: Subgroup analysis
NIH Required Analysis - Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Outcome measures
| Measure |
Non-Opioid
n=909 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Pain Average All by Race Ethnicity
Non-Hispanic Black
|
3.10 score on a scale
Interval 3.0 to 3.19
|
3.13 score on a scale
Interval 3.04 to 3.23
|
|
Pain Average All by Race Ethnicity
Non-Hispanic White
|
2.65 score on a scale
Interval 2.56 to 2.73
|
2.83 score on a scale
Interval 2.73 to 2.92
|
|
Pain Average All by Race Ethnicity
Non-Hispanic Asian
|
1.96 score on a scale
Interval 1.88 to 2.04
|
2.08 score on a scale
Interval 1.98 to 2.19
|
|
Pain Average All by Race Ethnicity
Hispanic
|
2.64 score on a scale
Interval 2.56 to 2.72
|
2.78 score on a scale
Interval 2.69 to 2.86
|
|
Pain Average All by Race Ethnicity
Other
|
2.99 score on a scale
Interval 2.74 to 3.24
|
3.14 score on a scale
Interval 2.86 to 3.42
|
|
Pain Average All by Race Ethnicity
Do Not Want to Report
|
2.64 score on a scale
Interval 2.4 to 2.89
|
2.74 score on a scale
Interval 2.46 to 3.03
|
POST_HOC outcome
Timeframe: Day of surgery (day 1) and 1 night after surgeryParticipants were asked "overall, how satisfied were you with your current pain medication". Responses were provided on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) Satisfaction 1 is the average of the response provided for the day of surgery and the 1st night after surgery.
Outcome measures
| Measure |
Non-Opioid
n=386 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=388 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Satisfaction 1
|
2.22 score on a scale
Interval 2.13 to 2.3
|
2.38 score on a scale
Interval 2.3 to 2.47
|
POST_HOC outcome
Timeframe: Day after surgery (day 2) and 2nd night after surgeryParticipants were asked "overall, how satisfied were you with your current pain medication". Responses were provided on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) Satisfaction 2 is the average of the response provided for the 1st day of after surgery (day 2) and the 2nd night after surgery.
Outcome measures
| Measure |
Non-Opioid
n=386 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=388 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Satisfaction 2
|
2.17 score on a scale
Interval 2.08 to 2.26
|
2.27 score on a scale
Interval 2.18 to 2.35
|
POST_HOC outcome
Timeframe: Second day after (day 3) and third night after surgeryParticipants were asked "overall, how satisfied were you with your current pain medication". Responses were provided on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) Satisfaction 3 is the average of the response provided for the 2nd day of after surgery (day 3) and the 3nd night after surgery.
Outcome measures
| Measure |
Non-Opioid
n=386 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=388 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Satisfaction 3
|
2.21 score on a scale
Interval 2.12 to 2.3
|
2.30 score on a scale
Interval 2.21 to 2.39
|
POST_HOC outcome
Timeframe: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)Participants were asked "overall, how satisfied were you with your current pain medication". Responses were provided on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) Satisfaction ALL is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Outcome measures
| Measure |
Non-Opioid
n=386 Participants
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=388 Participants
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Satisfaction All
|
2.24 score on a scale
Interval 2.14 to 2.34
|
2.27 score on a scale
Interval 2.18 to 2.36
|
Adverse Events
Non-Opioid
Opioid
Serious adverse events
| Measure |
Non-Opioid
n=909 participants at risk
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 participants at risk
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Infections and infestations
Spider Bite
|
0.00%
0/909 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
0.11%
1/906 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
|
Infections and infestations
Infection & Swelling
|
0.11%
1/909 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
0.11%
1/906 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
Other adverse events
| Measure |
Non-Opioid
n=909 participants at risk
Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
|
Opioid
n=906 participants at risk
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
|
|---|---|---|
|
Nervous system disorders
Pain
|
2.8%
25/909 • Number of events 25 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
3.0%
27/906 • Number of events 27 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
|
Injury, poisoning and procedural complications
Bleeding
|
0.55%
5/909 • Number of events 5 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
0.55%
5/906 • Number of events 5 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
|
Gastrointestinal disorders
Nausea
|
0.11%
1/909 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
0.11%
1/906 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
|
Gastrointestinal disorders
Diarrhea
|
0.11%
1/909 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
0.00%
0/906 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
|
Gastrointestinal disorders
Constipation
|
0.11%
1/909 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
0.00%
0/906 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
|
Nervous system disorders
Dizziness
|
0.11%
1/909 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
0.00%
0/906 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
|
Immune system disorders
Skin rash
|
0.00%
0/909 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
0.22%
2/906 • Number of events 2 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.11%
1/909 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
0.11%
1/906 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
|
Nervous system disorders
Headache
|
0.33%
3/909 • Number of events 3 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
0.11%
1/906 • Number of events 1 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
|
General disorders
Other
|
2.2%
20/909 • Number of events 20 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
1.5%
14/906 • Number of events 14 • Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
|
Additional Information
Cecile A. Feldman, DMD
Rutgers University School of Dental Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place