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| ID | Type | Description | Link |
|---|---|---|---|
| 5UH3DE028860-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
| University of Rochester | OTHER |
| University of Maryland, Baltimore | OTHER |
| University of Illinois at Chicago |
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The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results.
This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid | Active Comparator | Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. |
|
| Non-Opioid | Active Comparator | Combination of ibuprofen 400 mg/acetaminophen 500 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| opioid-containing analgesic | Drug | hydrocodone/ acetaminophen combination product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Pain 1 | 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). | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) |
| Composite Pain 2 | 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). | End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery) |
| Composite Pain 3 | 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). | End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Receiving Rescue Medication | Participant receiving additional pain medication (oxycodone) as study analgesic is not managing pain sufficiently | At post operative visit (9 days after surgery +/- 5 days) |
| Pain Interference 1 |
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Inclusion Criteria:
An individual must meet all of the following criteria to be eligible to participate in the study:
Be able to understand the informed consent.
Provide signed and dated informed consent form
Be able to understand all directions for data gathering instruments in English
Be willing and able to comply with all study procedures and be available for the duration of the study
Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd molars
Be 18 years or older
Be in good general health as evidenced by medical history
Women must agree to use one of the following methods of contraception while participating in this study:
Exclusion Criteria:
Participants who self-report the following history will be excluded from participating:
History of gastrointestinal bleeding and/or peptic ulcer
History of renal disease (excluding kidney stones)
History of hepatic disease
History of bleeding disorder
History of respiratory depression
Any prior respiratory effect of an opioid or other anesthetic drugs that required respiratory support postoperatively
Active or untreated asthma
History of known allegoric reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia
Currently taking any of the following medications:
Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism
History of drug or alcohol abuse
Family history of drug or alcohol abuse in a first-degree relative
Has had no more than one opioid prescription filled within the past 12 months
Currently pregnant or lactating
Participants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:
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| Name | Affiliation | Role |
|---|---|---|
| Cecile A Feldman, DMD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States | ||
| University of Maryland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39755971 | Derived | Feldman CA, Fredericks-Younger J, Desjardins PJ, Malmstrom H, Miloro M, Warburton G, Ward BB, Ziccardi VB, Greenberg P, Andrews T, Matheson PB, Benoliel R, Fine DH, Lu SE. Nonopioid vs opioid analgesics after impacted third-molar extractions: The Opioid Analgesic Reduction Study randomized clinical trial. J Am Dent Assoc. 2025 Feb;156(2):110-123.e9. doi: 10.1016/j.adaj.2024.10.014. Epub 2025 Jan 4. | |
| 35177108 | Derived | Feldman CA, Fredericks-Younger J, Lu SE, Desjardins PJ, Malmstrom H, Miloro M, Warburton G, Ward B, Ziccardi V, Fine D. The Opioid Analgesic Reduction Study (OARS)-a comparison of opioid vs. non-opioid combination analgesics for management of post-surgical pain: a double-blind randomized clinical trial. Trials. 2022 Feb 17;23(1):160. doi: 10.1186/s13063-022-06064-8. |
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Electronic Data Capture (EDC) will be used extensively throughout the course of the study for the collection of patient data as well as driving operational/logistical workflows. The database with data dictionary will be available.
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12 months after publication
Request data access from the PI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Opioid | Combination of ibuprofen 400 mg/acetaminophen 500 mg two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen) |
| FG001 | Opioid | Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Opioid | Combination of ibuprofen 400 mg/acetaminophen 500 mg two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen) |
| BG001 | Opioid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Pain 1 | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) |
|
Adverse even data was collected between the time of surgery and the post-operative visit which was 9 days +/- 5 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Opioid | Combination of ibuprofen 400 mg/acetaminophen 500 mg two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spider Bite | Infections and infestations | Non-systematic Assessment | Patient hospitalized due to complications from a spider bite |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecile A. Feldman, DMD | Rutgers University School of Dental Medicine | 973-972-4634 | feldman@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2024 | May 15, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2020 | Aug 31, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000377 | Agnosia |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| OTHER |
| University of Michigan | OTHER |
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This study was a double-blinded study. The participant, care provider, site directors and site research coordinators were all blinded.
| two over-the-counter analgesics |
| Drug |
combination of over-the-counter analgesics (ibuprofen/acetaminophen) |
|
| Composite Pain All |
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). |
| 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) |
| Overall Satisfaction | 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?" | At time of post-operative visit (day 9 +/- 5 days) |
| Pain Worst 1 | 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). | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) |
| Pain Worst 2 | 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.) | End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery |
| Pain Worst 3 | 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). | End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery) |
| Pain Worst All | 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). | 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) |
| Pain Average 1 | 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) | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) |
| Pain Average 2 | 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.) | End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery) |
| Pain Average 3 | 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). | End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery) |
| Pain Average All | 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). | 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 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.
| End of the day of surgery (day 1) |
| Pain Interference 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. | End of the first full day after surgery (day 2) |
| Pain Interference 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. | End of the second full day after surgery (day 3) |
| Pain Interference All | 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. | First 7 days after surgery |
| Sleep 1 | 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. | When first waking up the day after surgery |
| Sleep 2 | 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. | When first waking up the 2nd day after surgery |
| Sleep 3 | 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. | When first waking up the 3rd day after surgery |
| Sleep All | 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. | First 7 nights after surgery |
| Potential for Opioid Tablet Diversion | Number of returned opioid analgesic capsules at post operative visit (9 days after surgery +/- 5 days) | At post operative visit (9 days after surgery +/- 5 days) |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Rutgers School of Dental Medicine | Newark | New Jersey | 07101 | United States |
| University of Rochester | Rochester | New York | 14620 | United States |
| Lost to Follow-up |
|
| No Post-Op Visit |
|
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 3rd molars extracted | Number of 3rd molars extracted (range = 1 to 4) | Mean | Standard Deviation | teeth |
|
| Impacted full bony 3rd molars extracted | Number of full bony impacted 3rd molars extracted (range=0 to 4) | Mean | Standard Deviation | teeth |
|
| OG001 | Opioid | Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product |
|
|
| Primary | Composite Pain 2 | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery) |
|
|
|
| Primary | Composite Pain 3 | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery) |
|
|
|
| Primary | Composite Pain All | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | 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 | 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?" | Posted | Count of Participants | Participants | At time of post-operative visit (day 9 +/- 5 days) |
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|
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| Primary | Pain Worst 1 | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) |
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| Primary | Pain Worst 2 | 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.) | Posted | Mean | 95% Confidence Interval | score on a scale | End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery |
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| Primary | Pain Worst 3 | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery) |
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| Primary | Pain Worst All | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | 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) |
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| Primary | Pain Average 1 | 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) | Posted | Mean | 95% Confidence Interval | score on a scale | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) |
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| Primary | Pain Average 2 | 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.) | Posted | Mean | 95% Confidence Interval | score on a scale | End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery) |
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| Primary | Pain Average 3 | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery) |
|
|
|
| Primary | Pain Average All | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | 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) |
|
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| Secondary | Number of Participants Receiving Rescue Medication | Participant receiving additional pain medication (oxycodone) as study analgesic is not managing pain sufficiently | Posted | Count of Participants | Participants | At post operative visit (9 days after surgery +/- 5 days) |
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| Secondary | Pain Interference 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. | Posted | Mean | 95% Confidence Interval | score on a scale | End of the day of surgery (day 1) |
|
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| Secondary | Pain Interference 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. | Posted | Mean | 95% Confidence Interval | score on a scale | End of the first full day after surgery (day 2) |
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| Secondary | Pain Interference 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. | Posted | Mean | 95% Confidence Interval | score on a scale | End of the second full day after surgery (day 3) |
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| Secondary | Pain Interference All | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | First 7 days after surgery |
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| Secondary | Sleep 1 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | When first waking up the day after surgery |
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| Secondary | Sleep 2 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | When first waking up the 2nd day after surgery |
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| Secondary | Sleep 3 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | When first waking up the 3rd day after surgery |
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| Secondary | Sleep All | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | First 7 nights after surgery |
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| Secondary | Potential for Opioid Tablet Diversion | Number of returned opioid analgesic capsules at post operative visit (9 days after surgery +/- 5 days) | Posted | Mean | 95% Confidence Interval | capsules | At post operative visit (9 days after surgery +/- 5 days) |
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| Post-Hoc | Satisfaction 1 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Day of surgery (day 1) and 1 night after surgery |
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| Post-Hoc | Satisfaction 2 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Day after surgery (day 2) and 2nd night after surgery |
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| Post-Hoc | Satisfaction 3 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Second day after (day 3) and third night after surgery |
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| Post-Hoc | Satisfaction All | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | 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) |
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| 0 |
| 909 |
| 1 |
| 909 |
| 58 |
| 909 |
| EG001 | Opioid | Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. opioid-containing analgesic: hydrocodone/ acetaminophen combination product | 0 | 906 | 2 | 906 | 51 | 906 |
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| Infection & Swelling | Infections and infestations | Non-systematic Assessment |
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| Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Skin rash | Immune system disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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Not provided
Not provided
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Neither satisfied nor dissatisfied |
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| Dissatisfied |
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| Very dissatisfied |
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| MIssing |
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