Trial Outcomes & Findings for Opioid Analgesic Reduction Study (NCT NCT04452344)

NCT ID: NCT04452344

Last Updated: 2025-12-11

Results Overview

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).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1815 participants
• 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)
• Results posted on: 2025-12-11

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=237 Participants	25.81 Years STANDARD_DEVIATION 6.50 • n=243 Participants	25.69 Years STANDARD_DEVIATION 6.24 • n=480 Participants
Sex: Female, Male Female	457 Participants n=237 Participants	453 Participants n=243 Participants	910 Participants n=480 Participants
Sex: Female, Male Male	452 Participants n=237 Participants	453 Participants n=243 Participants	905 Participants n=480 Participants
Race/Ethnicity, Customized Hispanic	279 Participants n=237 Participants	282 Participants n=243 Participants	561 Participants n=480 Participants
Race/Ethnicity, Customized Non-Hispanic Asian	141 Participants n=237 Participants	131 Participants n=243 Participants	272 Participants n=480 Participants
Race/Ethnicity, Customized Non-Hispanic Black	255 Participants n=237 Participants	257 Participants n=243 Participants	512 Participants n=480 Participants
Race/Ethnicity, Customized Non-Hispanic White	179 Participants n=237 Participants	178 Participants n=243 Participants	357 Participants n=480 Participants
Race/Ethnicity, Customized Other	32 Participants n=237 Participants	30 Participants n=243 Participants	62 Participants n=480 Participants
Race/Ethnicity, Customized Did Not Want to Report	23 Participants n=237 Participants	28 Participants n=243 Participants	51 Participants n=480 Participants
3rd molars extracted	2.75 teeth STANDARD_DEVIATION 1.17 • n=237 Participants	2.75 teeth STANDARD_DEVIATION 1.21 • n=243 Participants	2.75 teeth STANDARD_DEVIATION 1.19 • n=480 Participants
Impacted full bony 3rd molars extracted	.96 teeth STANDARD_DEVIATION 1.23 • n=237 Participants	0.98 teeth STANDARD_DEVIATION 1.22 • n=243 Participants	.97 teeth STANDARD_DEVIATION 1.23 • n=480 Participants

PRIMARY outcome

Timeframe: End of day of surgery (day 1) and when waking up the next morning (1 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 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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Composite Pain 1	4.47 units on a scale Interval 4.28 to 4.65	3.77 units on a scale Interval 3.58 to 3.96

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Composite Pain 2	3.48 units on a scale Interval 3.29 to 3.67	3.20 units on a scale Interval 3.01 to 3.39

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Composite Pain 3	3.06 units on a scale Interval 2.87 to 3.25	2.97 units on a scale Interval 2.78 to 3.16

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Composite Pain All	2.94 units on a scale Interval 2.74 to 3.13	2.73 units on a scale Interval 2.54 to 2.92

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Overall Satisfaction MIssing	15 Participants	13 Participants
Overall Satisfaction Very Satisfied	308 Participants	355 Participants
Overall Satisfaction Satisfied	395 Participants	409 Participants
Overall Satisfaction Neither satisfied nor dissatisfied	122 Participants	87 Participants
Overall Satisfaction Dissatisfied	54 Participants	33 Participants
Overall Satisfaction Very dissatisfied	12 Participants	12 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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Worst 1	5.79 score on a scale Interval 5.47 to 6.1	4.90 score on a scale Interval 4.59 to 5.21

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 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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Worst 2	4.48 score on a scale Interval 4.17 to 4.8	4.17 score on a scale Interval 3.86 to 4.48

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Worst 3	3.96 score on a scale Interval 3.65 to 4.27	3.97 score on a scale Interval 3.65 to 4.28

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Worst All	3.79 score on a scale Interval 3.48 to 4.11	3.66 score on a scale Interval 3.34 to 3.97

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Average 1	4.47 score on a scale Interval 4.29 to 4.66	3.75 score on a scale Interval 3.57 to 3.94

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Average 2	3.49 score on a scale Interval 3.31 to 3.68	3.18 score on a scale Interval 3.0 to 3.37

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Average 3	3.07 score on a scale Interval 2.89 to 3.26	2.97 score on a scale Interval 2.78 to 3.15

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Average All	2.95 score on a scale Interval 2.76 to 3.14	2.69 score on a scale Interval 2.5 to 2.88

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Number of Participants Receiving Rescue Medication	54 Participants	26 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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Interference 1	3.11 score on a scale Interval 3.01 to 3.21	2.75 score on a scale Interval 2.65 to 2.85

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Interference 2	2.50 score on a scale Interval 2.4 to 2.59	2.27 score on a scale Interval 2.17 to 2.37

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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Interference 3	2.34 score on a scale Interval 2.24 to 2.44	2.20 score on a scale Interval 2.1 to 2.3

SECONDARY outcome

Timeframe: First 7 days after surgery

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 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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Pain Interference All	2.21 score on a scale Interval 2.13 to 2.3	2.09 score on a scale Interval 2.01 to 2.18

SECONDARY outcome

Timeframe: When first waking up the day after surgery

Participants 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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Sleep 1	4.62 score on a scale Interval 4.36 to 4.88	4.28 score on a scale Interval 4.02 to 4.54

SECONDARY outcome

Timeframe: When first waking up the 2nd day after surgery

Participants 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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Sleep 2	4.14 score on a scale Interval 3.88 to 4.4	4.10 score on a scale Interval 3.84 to 4.35

SECONDARY outcome

Timeframe: When first waking up the 3rd day after surgery

Participants 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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Sleep 3	3.82 score on a scale Interval 3.56 to 4.08	3.78 score on a scale Interval 3.52 to 4.04

SECONDARY outcome

Timeframe: First 7 nights after surgery

Participants 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	Opioid n=906 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Sleep All	3.62 score on a scale Interval 3.37 to 3.87	3.69 score on a scale Interval 3.44 to 3.94

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	Opioid n=891 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Potential for Opioid Tablet Diversion	8.55 capsules Interval 7.5 to 9.6	0 capsules Interval 0.0 to 0.0

POST_HOC outcome

Timeframe: Day of surgery (day 1) and 1 night 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 1 is the average of the response provided for the day of surgery and the 1st night after surgery.

Outcome measures

Measure	Opioid n=388 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Satisfaction 1	2.38 score on a scale Interval 2.3 to 2.47	2.22 score on a scale Interval 2.13 to 2.3

POST_HOC outcome

Timeframe: Day after surgery (day 2) and 2nd night 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 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	Opioid n=388 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Satisfaction 2	2.27 score on a scale Interval 2.18 to 2.35	2.17 score on a scale Interval 2.08 to 2.26

POST_HOC outcome

Timeframe: Second day after (day 3) and third night 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 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	Opioid n=388 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Satisfaction 3	2.30 score on a scale Interval 2.21 to 2.39	2.21 score on a scale Interval 2.12 to 2.3

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	Opioid n=388 Participants Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product	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)
Satisfaction All	2.27 score on a scale Interval 2.18 to 2.36	2.24 score on a scale Interval 2.14 to 2.34

Adverse Events

Non-Opioid

Serious events: 1 serious events

Other events: 58 other events

Deaths: 0 deaths

Opioid

Serious events: 2 serious events

Other events: 51 other events

Deaths: 0 deaths

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

Phone: 973-972-4634

Email: feldman@rutgers.edu

Results disclosure agreements

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