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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
| University of Maryland, Baltimore | OTHER |
| University of Michigan | OTHER |
| University of Rochester |
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The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.
A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid | Active Comparator | Combination analgesic of hydrocodone 5mg/acetaminophen350 mg |
|
| Non-Opioid | Active Comparator | Combination analgesic of ibuprofen 400mgacademinophen 350mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPIOID | Drug | Analgesic assignment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level | Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable) | 1st day |
| Pain Level | Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain | Average for the 1st and 2nd day |
| Pain Level | Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain | Average for the first seven days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible) | 1st night |
| Sleep Quality | Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible) |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who self-report the following history will be excluded from participating:
Individual under the age of 18
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 drug that required respiratory support postoperatively
Active or untreated asthma
History of known allergic 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 (excludes marijuana use)
Family history of drug or alcohol abuse in a first degree relative
Has had one or more opioid prescription filled within the past 6 months
Currently pregnant or lactating
Patients 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 |
|---|---|---|
| Janine Fredericks-Younger, DMD | Rutgers School of Dental Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Chicago | Chicago | Illinois | 60607 | United States | ||
| University of Maryland |
Upon written request to the principle investigator data will be provided as de-identified data in csv file format.
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Data will be available after publication of primary and secondary outcomes. Data will be available for 3 years.
Requester must have a valid e-mail address.
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| ID | Title | Description |
|---|---|---|
| FG000 | Opioid | Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment |
| FG001 | Non-Opioid | Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Opioid | Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment |
| BG001 | Non-Opioid | Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pain Level | Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable) | Posted | Mean | Standard Error | score on a scale | 1st day |
|
|
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
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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 | OPIOID | Received hydrocodone/acetaminophen | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecile A. Feldman | 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 | Jun 28, 2021 | May 10, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2020 | May 5, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| D018712 | Analgesics, Non-Narcotic |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| OTHER |
A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
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Analgesic is formulate in capsules. Both OPIOID and NON-OPIOID analgesic formulas are packaged in the same capsules
| NON-OPIOID | Drug | Analgesic assignment |
|
|
| Average for the 1st and 2nd night |
| Sleep Quality | Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible) | Average for the 1st, 2nd and 3rd night |
| Sleep Quality | Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible) | Average for the first seven nights post surgery |
| Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 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 | 1st day |
| Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 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 | Average for the 1st and 2nd day |
| Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 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 | Average for the 1st, 2nd and 3rd day |
| Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 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 | Average for the first seven days post surgery |
| Overall Satisfaction | 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) | Average for the first seven days post surgery |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Rutgers University | Newark | New Jersey | 07103 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Pain Level | Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain | Posted | Mean | Standard Error | score on a scale | Average for the 1st and 2nd day |
|
|
|
| Primary | Pain Level | Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain | Posted | Mean | Standard Error | score on a scale | Average for the first seven days post surgery |
|
|
|
| Secondary | Sleep Quality | Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible) | Posted | Mean | Standard Error | score on a scale | 1st night |
|
|
|
| Secondary | Sleep Quality | Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible) | Posted | Mean | Standard Error | score on a scale | Average for the 1st and 2nd night |
|
|
|
| Secondary | Sleep Quality | Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible) | Posted | Mean | Standard Error | score on a scale | Average for the 1st, 2nd and 3rd night |
|
|
|
| Secondary | Sleep Quality | Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible) | Posted | Mean | Standard Error | score on a scale | Average for the first seven nights post surgery |
|
|
|
| Secondary | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 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 | Posted | Mean | Standard Error | score on a scale | 1st day |
|
|
|
| Secondary | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 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 | Posted | Mean | Standard Error | score on a scale | Average for the 1st and 2nd day |
|
|
|
| Secondary | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 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 | Posted | Mean | Standard Error | score on a scale | Average for the 1st, 2nd and 3rd day |
|
|
|
| Secondary | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 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 | Posted | Mean | Standard Error | score on a scale | Average for the first seven days post surgery |
|
|
|
| Secondary | Overall Satisfaction | 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) | Posted | Mean | Standard Deviation | score on a scale | Average for the first seven days post surgery |
|
|
|
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | NON-OPIOID | Received ibuprofen/acetaminophen | 0 | 25 | 0 | 25 | 0 | 25 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |