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This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. Participants will be randomized like a flip of a coin to either the standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.
Pain control in the postoperative period following septum and/or sinus surgery is controversial, as there is no consensus statement regarding current guidelines to direct clinical practice. Recent legislation limits opioid prescription length to 5 days only, which brings into question whether legislation will affect prescribing practices of physicians and whether or not giving patients an alternative to opiates will be a more efficacious route.
Current prescribing practices for septum and sinus surgery of the Otolaryngology private practice group includes as-needed acetaminophen 325 mg and as-needed acetaminophen/hydrocodone 7.5 mg/325 mg. If it can be demonstrated that use of 650 mg acetaminophen in scheduled doses of every 6 hours can decrease postoperative opiate use in the first week without significantly increase in patient pain, this may be deployed as an effective strategy of pain control as the use of opiates has come under scrutiny and attempts are being made to decrease or limit the use of these medications in the medical setting.
This study would look to demonstrate that scheduled doses of acetaminophen as opposed to reactionary as-needed acetaminophen can control post-operative pain to the point where narcotics would not be necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care arm | Active Comparator | Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain. |
|
| Study Arm | Experimental | Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen 325 mg Oral Tablet | Drug | Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Doses of Opiate (Narcotic) Pain Medication | Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Highest Subjective Pain Score | Highest post-operative pain score during the first postoperative week as measured on an 11-point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible. | 7 days |
| Lowest Subjective Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Seel, DO. | William Beaumont Hospital - Farmington Hills | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital | Farmington Hills | Michigan | 48336 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Arm | Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain. Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain |
| FG001 | Study Arm | Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,. Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
65 patients were enrolled. Baseline data on sex is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Arm | Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain. Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain |
| 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 | Number of Doses of Opiate (Narcotic) Pain Medication | Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week. | 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up. | Posted | Median | Inter-Quartile Range | number of doses | 7 days |
|
7 days
65 patients were enrolled. Data on adverse events including mortality is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
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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 | Standard of Care Arm | Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain. Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Shecter, DO | William Beaumont Hospitals | 2487629363 | mitchell.shecter@corewellhealth.org |
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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 | Oct 31, 2019 | Aug 2, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D013607 | Tablets |
| D010098 | Oxycodone |
| C025153 | Aspirin-oxycodone hydrochloride-oxycodone terephthalate combination |
| C514822 | oxycodone-acetaminophen |
| D006853 | Hydrocodone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Open, randomized into one of two arms study. Study arm 1: Standard of care arm of Acetaminophen (Tylenol) 325 mg every 6 hours as needed plus acetaminophen/hydrocodone 7.5 mg/325mg every 4 hours for breakthrough pain. Study arm 2: Acetaminophen 650 mg. every 6 hours round the clock plus 5 mg oxycodone every 4 hours as needed for breakthrough pain.
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| Acetaminophen 650 mg Oral Tablet | Drug | Acetaminophen 650 mg scheduled every 6 hours round the clock for pain |
|
|
| OxyCODONE 5 mg Oral Tablet | Drug | Oxycodone 5 mg every 4 hours as needed for breakthrough pain |
|
|
| Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet | Drug | Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain |
|
|
Lowest post-operative pain score during the first postoperative week as measured on an 11 point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible.
| 7 days |
| Percentage of Time Participant Experienced Severe Pain | Percentage of time participant experienced severe pain requiring breakthrough pain medication during the first postoperative week, as measured on an 11 point numeric scale, from 0% to 100%, where 0% means never in severe pain and 100% means always in severe pain. | 7 days |
| Participant Use of Acetaminophen as Needed | Number of participants who took acetaminophen as needed during the first postoperative week. | 7 days |
| Participant Use of Scheduled Acetaminophen Around the Clock | Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week. | 7 days |
| Chronic Use of Pain Medication | Number of participants who answered "Yes" to the survey question, "Do you take pain medication, including narcotics, for any other medical condition?" | 7 days |
| Participant Use of Additional Pain Medication | Number of participants who took other pain medication (over-the-counter or narcotic) in addition to study-prescribed pain medications during first postoperative week. | 7 days |
| Types of Other Pain Medication Used | Self-reported name of pain medication (over-the-counter or narcotic) used by participants in addition to study-prescribed pain medications during the first postoperative week | 7 days |
| BG001 | Study Arm | Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,. Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | 65 patients were enrolled. Baseline data on sex is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Study Arm | Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,. Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain |
|
|
| Secondary | Highest Subjective Pain Score | Highest post-operative pain score during the first postoperative week as measured on an 11-point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible. | 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up. | Posted | Median | Inter-Quartile Range | score on a scale | 7 days |
|
|
|
| Secondary | Lowest Subjective Pain Score | Lowest post-operative pain score during the first postoperative week as measured on an 11 point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible. | 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up. | Posted | Median | Inter-Quartile Range | score on a scale | 7 days |
|
|
|
| Secondary | Percentage of Time Participant Experienced Severe Pain | Percentage of time participant experienced severe pain requiring breakthrough pain medication during the first postoperative week, as measured on an 11 point numeric scale, from 0% to 100%, where 0% means never in severe pain and 100% means always in severe pain. | 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up. | Posted | Median | Inter-Quartile Range | percentage of time | 7 days |
|
|
|
| Secondary | Participant Use of Acetaminophen as Needed | Number of participants who took acetaminophen as needed during the first postoperative week. | 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Participant Use of Scheduled Acetaminophen Around the Clock | Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week. | 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Chronic Use of Pain Medication | Number of participants who answered "Yes" to the survey question, "Do you take pain medication, including narcotics, for any other medical condition?" | 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Participant Use of Additional Pain Medication | Number of participants who took other pain medication (over-the-counter or narcotic) in addition to study-prescribed pain medications during first postoperative week. | 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Types of Other Pain Medication Used | Self-reported name of pain medication (over-the-counter or narcotic) used by participants in addition to study-prescribed pain medications during the first postoperative week | 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Study Arm | Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,. Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain | 0 | 13 | 0 | 13 | 0 | 13 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| ibuprofen |
|
| None |
|