Trial · NCT04452344
Opioid Analgesic Reduction Study
NCT04452344, Phase 3, Completed, Rutgers, The State University of New Jersey; results first posted 2024-07-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Opioid Analgesic Reduction Study. Trials, record NCT04452344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04452344
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Opioid Analgesic Reduction Study
- NCT number
- NCT04452344
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,815 participants, actual
- Lead sponsor
- Rutgers, The State University of New Jersey
- Conditions
- Opioid Use
- Interventions
- opioid-containing analgesic, two over-the-counter analgesics
- First posted
- 2020-06-30
- Last updated
- 2026-08-31
- Results first posted
- 2024-07-30
Source ClinicalTrials.gov
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Pain 1 | 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). |
| Primary | Composite Pain 2 | 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). |
| Primary | Composite Pain 3 | 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). |
| Primary | Composite Pain All | 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). |
| Primary | Overall Satisfaction | 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?" |
| Primary | Pain Worst 1 | 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). |
| Primary | Pain Worst 2 | 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.) |
| Primary | Pain Worst 3 | 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). |
| Primary | Pain Worst All | 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). |
| Primary | Pain Average 1 | 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) |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Pain 1 | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) | units on a scale | MEAN | |
| PRIMARY | Composite Pain 2 | End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery) | units on a scale | MEAN | |
| PRIMARY | Composite Pain 3 | End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery) | units on a scale | MEAN | |
| PRIMARY | Composite Pain All | 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) | units on a scale | MEAN | |
| PRIMARY | Overall Satisfaction | At time of post-operative visit (day 9 +/- 5 days) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Pain Worst 1 | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) | score on a scale | MEAN | |
| PRIMARY | Pain Worst 2 | End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery | score on a scale | MEAN | |
| PRIMARY | Pain Worst 3 | End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery) | score on a scale | MEAN | |
| PRIMARY | Pain Worst All | 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) | score on a scale | MEAN | |
| PRIMARY | Pain Average 1 | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) | score on a scale | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Pain 1 | Non-Opioid | 3.77 | 95% Confidence Interval 3.58 to 3.96 | units on a scale | |
| Composite Pain 1 | Opioid | 4.47 | 95% Confidence Interval 4.28 to 4.65 | units on a scale | |
| Composite Pain 2 | Non-Opioid | 3.20 | 95% Confidence Interval 3.01 to 3.39 | units on a scale | |
| Composite Pain 2 | Opioid | 3.48 | 95% Confidence Interval 3.29 to 3.67 | units on a scale | |
| Composite Pain 3 | Non-Opioid | 2.97 | 95% Confidence Interval 2.78 to 3.16 | units on a scale | |
| Composite Pain 3 | Opioid | 3.06 | 95% Confidence Interval 2.87 to 3.25 | units on a scale | |
| Composite Pain All | Non-Opioid | 2.73 | 95% Confidence Interval 2.54 to 2.92 | units on a scale | |
| Composite Pain All | Opioid | 2.94 | 95% Confidence Interval 2.74 to 3.13 | units on a scale | |
| Overall Satisfaction | Non-Opioid | Very Satisfied | 355 | Participants | |
| Overall Satisfaction | Opioid | Very Satisfied | 308 | Participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Non-Opioid | 909 | |
| Overall Study | STARTED | Opioid | 906 | |
| Overall Study | COMPLETED | Non-Opioid | 897 | |
| Overall Study | COMPLETED | Opioid | 889 | |
| Overall Study | NOT COMPLETED | Non-Opioid | 12 | |
| Overall Study | NOT COMPLETED | Opioid | 17 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain | Nervous system disorders | Non-Opioid | 25 | 909 | 25 |
| other | Pain | Nervous system disorders | Opioid | 27 | 906 | 27 |
| other | Bleeding | Injury, poisoning and procedural complications | Non-Opioid | 5 | 909 | 5 |
| other | Bleeding | Injury, poisoning and procedural complications | Opioid | 5 | 906 | 5 |
| other | Nausea | Gastrointestinal disorders | Non-Opioid | 1 | 909 | 1 |
| other | Nausea | Gastrointestinal disorders | Opioid | 1 | 906 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Non-Opioid | 1 | 909 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Opioid | 0 | 906 | 0 |
| other | Constipation | Gastrointestinal disorders | Non-Opioid | 1 | 909 | 1 |
| other | Constipation | Gastrointestinal disorders | Opioid | 0 | 906 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-Opioid | 0 | 909 |
| Total, all-cause mortality | Opioid | 0 | 906 |
| Total, other adverse events | Non-Opioid | 58 | 909 |
| Total, other adverse events | Opioid | 51 | 906 |
| Total, serious adverse events | Non-Opioid | 1 | 909 |
| Total, serious adverse events | Opioid | 2 | 906 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UH3DE028860 | Opiod Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain | FELDMAN, CECILE | RUTGERS BIOMEDICAL AND HEALTH SCIENCES | NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH | 2020 to 2023 | NIH RePORTER |
| UG3DE028860 | Opiod Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain | FELDMAN, CECILE | RBHS-SCHOOL OF DENTAL MEDICINE | NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH | 2019 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Non-Opioid vs Opioid: Number of Participants Receiving Rescue Medication | Trial comparisons |
| Non-Opioid vs Opioid: deaths from any cause | Trial comparisons |
| Non-Opioid vs Opioid: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04452344
GET https://conductscience.org/api/trials/v1/NCT04452344/registered?page=2