Trial Outcomes & Findings for Opioid Analgesic Reduction Study (OARS) - Pilot (NCT NCT05283499)

NCT ID: NCT05283499

Last Updated: 2023-06-06

Results Overview

Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 53 participants
• Primary outcome timeframe: 1st day
• Results posted on: 2023-06-06

Participant Flow

Participant milestones

Measure	Opioid Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Overall Study STARTED	26	27
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Opioid Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Overall Study Did not receive intervention	1	2

Baseline Characteristics

Opioid Analgesic Reduction Study (OARS) - Pilot

Baseline characteristics by cohort

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 1st day

Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Pain Level	5.67 score on a scale Standard Error 0.59	4.09 score on a scale Standard Error 0.59

PRIMARY outcome

Timeframe: Average for the 1st and 2nd day

Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Pain Level	5.10 score on a scale Standard Error 0.58	3.57 score on a scale Standard Error 0.58

PRIMARY outcome

Timeframe: Average for the first seven days post surgery

Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Pain Level	4.00 score on a scale Standard Error 0.54	2.74 score on a scale Standard Error 0.54

SECONDARY outcome

Timeframe: 1st night

Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Sleep Quality	5.45 score on a scale Standard Error 0.69	3.76 score on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: Average for the 1st and 2nd night

Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Sleep Quality	5.25 score on a scale Standard Error 0.64	3.44 score on a scale Standard Error 0.65

SECONDARY outcome

Timeframe: Average for the 1st, 2nd and 3rd night

Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Sleep Quality	4.91 score on a scale Standard Error 0.63	3.36 score on a scale Standard Error 0.63

SECONDARY outcome

Timeframe: Average for the first seven nights post surgery

Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Sleep Quality	4.38 score on a scale Standard Error 0.60	2.89 score on a scale Standard Error 0.60

SECONDARY outcome

Timeframe: 1st day

Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always)

The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?

Minimum = 6, Maximum = 30; lower is better and higher is worse outcome

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	17.62 score on a scale Standard Error 1.27	14.34 score on a scale Standard Error 1.26

SECONDARY outcome

Timeframe: Average for the 1st and 2nd day

Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always)

The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?

Minimum = 6, Maximum = 30; lower is better and higher is worse outcome

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	16.21 score on a scale Standard Error 1.18	12.91 score on a scale Standard Error 1.19

SECONDARY outcome

Timeframe: Average for the 1st, 2nd and 3rd day

Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always)

The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?

Minimum = 6, Maximum = 30; lower is better and higher is worse outcome

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	15.50 score on a scale Standard Error 1.15	12.19 score on a scale Standard Error 1.16

SECONDARY outcome

Timeframe: Average for the first seven days post surgery

Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always)

The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?

Minimum = 6, Maximum = 30; lower is better and higher is worse outcome

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	13.74 score on a scale Standard Error 1.12	11.01 score on a scale Standard Error 1.13

SECONDARY outcome

Timeframe: Average for the first seven days post surgery

Subject's rating of overall satisfaction with the analgesic provided after surgery on a 5 point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied)

Outcome measures

Measure	Opioid n=25 Participants Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Non-Opioid n=25 Participants Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Overall Satisfaction	2.1 score on a scale Standard Deviation 1.4	1.7 score on a scale Standard Deviation 0.89

Adverse Events

OPIOID

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

NON-OPIOID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	OPIOID n=25 participants at risk Received hydrocodone/acetaminophen	NON-OPIOID n=25 participants at risk Received ibuprofen/acetaminophen
Gastrointestinal disorders Constipation	4.0% 1/25 • Number of events 1 • Post-operative Period -- 9 Days +/- 5 days from surgery Adverse event is defined as an event which required a unexpected office visit or visit to an emergency room and could be related to study intervention	0.00% 0/25 • Post-operative Period -- 9 Days +/- 5 days from surgery Adverse event is defined as an event which required a unexpected office visit or visit to an emergency room and could be related to study intervention

Additional Information

Cecile A. Feldman

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