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To understand how patients perceive the quality of care they receive when given different post-operative analgesic medications. Specifically the investigators want to assess whether patients who receive non-opioid analgesia following surgery endorse appropriate quality and satisfaction with their care compared to those who receive opioid medication.
It is routine practice to give analgesic medication after any surgical procedure to provide adequate pain control for patients. However with the increase in abuse of opioid prescription medications, physicians have given a new emphasis to different pain regimens that aim to limit the use of opioid medications. The investigator's previous clinical trial demonstrated that for patients undergoing outpatient otolaryngology procedures, not only does Ibuprofen provide equally effective analgesia compared to opioid medication but it can also decrease overall opioid requirement.
In the current proposed study, the investigators wish to build on previous work. The investigators hypothesize that with the addition of Acetaminophen to Ibuprofen, patients undergoing outpatient otolaryngology procedures may not require opioid analgesia at all. While numerous studies corroborate these results, there is little information about patients' satisfaction with their care in light of a shifting emphasis on decreasing opioid prescription. The primary goal of the current study is to better understand patients' perception of care and level of satisfaction when given opioid versus non-opioid postoperative analgesia. If there is conflicting data with regards to patients reporting adequate pain control but poor satisfaction, then perhaps further public health intervention may be necessary to provide additional patient education to help re-establish appropriate and safe patient expectations for postsurgical analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Hydrocodone/Acetaminophen and Ibuprofen | This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. | ||
| Group 2: Ibuprofen and Hydrocodone/acetaminophen | This group will take Ibuprofen 600mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. | ||
| Group 3: Ibuprofen and Acetaminophen | This group will take Ibuprofen 600mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Acetaminophen 650mg every 6 hours as needed for additional pain control. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with post operative pain control | Patients will be surveyed if they were satisfied with their pain regimen and efficacy of pain control on a scale of 1-5. With 1 being very unsatisfied and 5 being very satisfied. | First clinic visit after surgery (7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of analgesic regimen and patient attitudes toward treatment they received | Patients attitude and overall experience with regards to their pain management will be assessed via the following questions:
|
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Inclusion Criteria:
Patients between the ages of 18 and 89 years of age
Patients undergoing the following outpatient procedures:
Exclusion Criteria:
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Study population is comprised of outpatients undergoing specific outpatient surgery procedures as outline in the inclusion criteria, at an LLUHS associated surgical facility.
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| Name | Affiliation | Role |
|---|---|---|
| Khanh Nguyen, MD | Loma Linda University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health System | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32191688 | Background | Wilson N, Kariisa M, Seth P, Smith H 4th, Davis NL. Drug and Opioid-Involved Overdose Deaths - United States, 2017-2018. MMWR Morb Mortal Wkly Rep. 2020 Mar 20;69(11):290-297. doi: 10.15585/mmwr.mm6911a4. | |
| 31846008 | Background | Olfson M, Rossen LM, Wall MM, Houry D, Blanco C. Trends in Intentional and Unintentional Opioid Overdose Deaths in the United States, 2000-2017. JAMA. 2019 Dec 17;322(23):2340-2342. doi: 10.1001/jama.2019.16566. |
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There is no plan to share participants data after this study is finished with other researchers.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D017060 | Patient Satisfaction |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| First clinic visit after surgery (7 days) |
| 30646062 | Background | Gomes T, Tadrous M, Mamdani MM, Paterson JM, Juurlink DN. The Burden of Opioid-Related Mortality in the United States. JAMA Netw Open. 2018 Jun 1;1(2):e180217. doi: 10.1001/jamanetworkopen.2018.0217. |
| 31774562 | Background | Pruitt LCC, Casazza GC, Newberry CI, Cardon R, Ramirez A, Krakovitz PR, Meier JD, Skarda DE. Opioid Prescribing and Use in Ambulatory Otolaryngology. Laryngoscope. 2020 Aug;130(8):1913-1921. doi: 10.1002/lary.28359. Epub 2019 Nov 27. |
| 31225905 | Background | Dang S, Duffy A, Li JC, Gandee Z, Rana T, Gunville B, Zhan T, Curry J, Luginbuhl A, Cottrill E, Cognetti D. Postoperative opioid-prescribing practices in otolaryngology: A multiphasic study. Laryngoscope. 2020 Mar;130(3):659-665. doi: 10.1002/lary.28101. Epub 2019 Jun 21. |
| 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. |
| 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. |
| 30286851 | Background | Ilyas AM, Miller AJ, Graham JG, Matzon JL. Pain Management After Carpal Tunnel Release Surgery: A Prospective Randomized Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone. J Hand Surg Am. 2018 Oct;43(10):913-919. doi: 10.1016/j.jhsa.2018.08.011. |
| 26824844 | Background | Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016. |
| 31834679 | Background | Wu AW, Walgama ES, Genc E, Ting JY, Illing EA, Shipchandler TZ, Higgins TS. Multicenter study on the effect of nonsteroidal anti-inflammatory drugs on postoperative pain after endoscopic sinus and nasal surgery. Int Forum Allergy Rhinol. 2020 Apr;10(4):489-495. doi: 10.1002/alr.22506. Epub 2019 Dec 13. |
| 32127178 | Background | Papoian V, Handy KG, Villano AM, Tolentino RA, Hassanein MT, Nosanov LS, Felger EA. Randomized control trial of opioid- versus nonopioid-based analgesia after thyroidectomy. Surgery. 2020 Jun;167(6):957-961. doi: 10.1016/j.surg.2020.01.011. Epub 2020 Feb 29. |
| 30832548 | Background | Nguyen KK, Liu YF, Chang C, Park JJ, Kim CH, Hondorp B, Vuong C, Xu H, Crawley BK, Simental AA, Church CA, Inman JC. A Randomized Single-Blinded Trial of Ibuprofen- versus Opioid-Based Primary Analgesic Therapy in Outpatient Otolaryngology Surgery. Otolaryngol Head Neck Surg. 2019 May;160(5):839-846. doi: 10.1177/0194599819832528. Epub 2019 Mar 5. |
| 32536501 | Background | Gostian AO, Loeser J, Tholen C, Wolber P, Otte M, Schwarz D, Heindl LM, Balk M, Gostian M. Postoperative pain after tonsillectomy - the value of standardized analgesic treatment protocols. Auris Nasus Larynx. 2020 Dec;47(6):1009-1017. doi: 10.1016/j.anl.2020.05.011. Epub 2020 Jun 12. |
| 31154092 | Background | Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |