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Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home.
It is routine practice to give narcotic medication after surgery for pain control however the abuse of prescription medications has become the fastest growing drug problem in the United States. Research has shown that post operative pain for some common Ear, Nose, and Throat (ENT) procedures are not severe but there is limited data looking at patient narcotic needs and their usage pattern to help inform physicians on how much to prescribe.
The objective of this study is to evaluate patient pain level in the immediate post-operative period and quantify pain medication usage in patients who undergo outpatient ENT surgeries.
Patients who undergo the following procedures will be invited to participate: thyroidectomy, parathyroidectomy, parotidectomy, tympanoplasty, mastoidectomy, endoscopic sinus surgery, and septoplasty. All patients will receive Hydrocodone/acetaminophen and Ibuprofen in standard dosage and assigned to one of two groups before surgery. Group 1 will use the narcotic medication for pain control and ibuprofen for breakthrough pain. Group 2 will use ibuprofen for pain control and the narcotic medication for breakthrough. Patients will fill out a data sheet for 7 days recording their pain level three times per day as well as pain medication usage for each day. This will be collected on their first clinic visit after surgery at which point the patient's involvement is completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norco and Ibuprofen | Experimental | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. |
|
| Ibuprofen and Norco | Active Comparator | This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norco | Drug | Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Usage | The average number of narcotic pills needed or used for pain control | First 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Pain Level | The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain. | Average reported pain for first 7 days after surgery |
| Ibuprofen Usage |
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Inclusion Criteria:
Patients undergoing one of the following outpatient procedure:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Inman, MD | Loma Linda University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States | ||
| Loma Linda University Surgical Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19221238 | Background | Sommer M, Geurts JW, Stessel B, Kessels AG, Peters ML, Patijn J, van Kleef M, Kremer B, Marcus MA. Prevalence and predictors of postoperative pain after ear, nose, and throat surgery. Arch Otolaryngol Head Neck Surg. 2009 Feb;135(2):124-30. doi: 10.1001/archoto.2009.3. | |
| 17298314 | Background | Foghsgaard S, Foghsgaard J, Homoe P. Early post-operative morbidity after superficial parotidectomy: a prospective study concerning pain and resumption of normal activity. Clin Otolaryngol. 2007 Feb;32(1):54-7. doi: 10.1111/j.1365-2273.2007.01315.x. |
| Label | URL |
|---|---|
| CDC report on opioid related deaths | View source |
Not provided
Collected data will be analyzed and published. Meaningful data will be available through published material.
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| ID | Title | Description |
|---|---|---|
| FG000 | Norco and Ibuprofen | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control |
| FG001 | Ibuprofen and Norco | This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients who completed and returned pain data entry
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| ID | Title | Description |
|---|---|---|
| BG000 | Norco and Ibuprofen | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control |
| 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 | Narcotic Usage | The average number of narcotic pills needed or used for pain control | Posted | Mean | 95% Confidence Interval | Pills | First 7 days after surgery |
|
Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery
Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery
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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 | Norco and Ibuprofen | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment | Patient reported headache |
Some patients chose to not follow study instructions strictly and utilized ibuprofen therapy as primary analgesic treatment instead of their opioid medication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Khanh Nguyen, MD | Loma Linda University Health System | 909-558-8558 | khanguyen@llu.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 | Dec 16, 2018 | Jan 8, 2022 | Prot_SAP_001.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 |
|---|---|
| C514822 | oxycodone-acetaminophen |
| D009294 | Narcotics |
| D007052 | Ibuprofen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Patients will be randomized to one of two groups prior to surgery. All patients will be prescribed both Hydrocodone/acetaminophen and Ibuprofen. Group 1 will take the narcotic medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 will take Ibuprofen for initial pain control followed by the narcotic medication if pain is not adequately controlled.
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| Ibuprofen | Drug | Ibuprofen as first line therapy every 6 hours as needed for pain control |
|
|
The average number of ibuprofen pills needed or used for pain control
| First 7 days after surgery |
| Loma Linda |
| California |
| 92354 |
| United States |
| 26422088 | Background | Song CM, Ji YB, Bang HS, Kim KR, Kim H, Tae K. Postoperative Pain After Robotic Thyroidectomy by a Gasless Unilateral Axillo-Breast or Axillary Approach. Surg Laparosc Endosc Percutan Tech. 2015 Dec;25(6):478-82. doi: 10.1097/SLE.0000000000000204. |
| 24735082 | Background | van Dijk JF, Kappen TH, Schuurmans MJ, van Wijck AJ. The Relation Between Patients' NRS Pain Scores and Their Desire for Additional Opioids after Surgery. Pain Pract. 2015 Sep;15(7):604-9. doi: 10.1111/papr.12217. Epub 2014 Apr 16. |
| 21840522 | Background | van Dijk JF, van Wijck AJ, Kappen TH, Peelen LM, Kalkman CJ, Schuurmans MJ. Postoperative pain assessment based on numeric ratings is not the same for patients and professionals: a cross-sectional study. Int J Nurs Stud. 2012 Jan;49(1):65-71. doi: 10.1016/j.ijnurstu.2011.07.009. Epub 2011 Aug 15. |
| 21724620 | Background | Gerbershagen HJ, Rothaug J, Kalkman CJ, Meissner W. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth. 2011 Oct;107(4):619-26. doi: 10.1093/bja/aer195. Epub 2011 Jun 30. |
| 24521559 | Background | Ossiander EM. Using textual cause-of-death data to study drug poisoning deaths. Am J Epidemiol. 2014 Apr 1;179(7):884-94. doi: 10.1093/aje/kwt333. Epub 2014 Feb 11. |
| BG001 |
| Ibuprofen and Norco |
This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Prior Narcotic use | Count of Participants | Participants |
|
| Chronic Pain | Count of Participants | Participants |
|
| Surgery Length | Mean | Standard Deviation | minutes |
|
| Revision Surgery | Count of Participants | Participants |
|
|
|
| Secondary | Patient Pain Level | The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Average reported pain for first 7 days after surgery |
|
|
|
| Secondary | Ibuprofen Usage | The average number of ibuprofen pills needed or used for pain control | Posted | Mean | 95% Confidence Interval | pills | First 7 days after surgery |
|
|
|
| 0 |
| 97 |
| 0 |
| 97 |
| 4 |
| 97 |
| EG001 | Ibuprofen and Norco | This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control | 0 | 88 | 0 | 88 | 3 | 88 |
| Drainage from surgical site | Surgical and medical procedures | Non-systematic Assessment | Patient had additional blood tinged secretion from surgical site |
|
| Uncontrolled pain | Surgical and medical procedures | Non-systematic Assessment | Patient requiring additional pain medication refill |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Patient reported nausea |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D018712 | Analgesics, Non-Narcotic |
| D000893 | Anti-Inflammatory Agents |
| D018501 | Antirheumatic Agents |