Pain Management Following Sinus Surgery

Study Overview
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Brief Summary
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This Study evaluates the effect of adding Non-steroidal anti-inflammatories (NSAIDs) to the post-operative pain management of sinus surgery patients and wether or not this addition reduces or eliminates the need for narcotic pain medications. Patients will be instructed to take an NSAID regimen after surgery and will be instructed to take narcotics only for breakthrough pain.

Detailed Description
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National attention has been given to the concerning rise of opioid abuse in this country, with prescriptions for this medications more than quadrupaling in the last 17 years. Little is known as to the appropriate use of opioid analgesics in the post-operative recovery of patients undergoing sinus surgery. Furthermore, most pain protocols include only Tylenol based opioid analgesics. No study has prospectively evaluated the volume of use of Tylenol based opioid analgesics and whether the addition of NSAIDS decreased the need for opioid analgesics. This study will compare opioid use with and without the addition of NSAIDS following sinus surgery. Post-operative opioid use is a great public health concern, relatively unstudied, and an area with an opportunity for potential intervention to significantly reduce risks, morbidity, and mortality to our postoperative patients by better formulating a postoperative pain management plan using evidence-based practices. Appropriate opioid prescribing practices can reduce the risk of addiction, drug overdose, death, and undertreated pain. By optimizing post-operative pain management protocols, the need for opioids following sinus surgery should be minimized.

Official Title
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Post-operative Pain Management Following Functional Endoscopic Sinus Surgery

Conditions
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Opioid Abuse, Nasal Sinus; Inflammation, Pain, Postoperative

Intervention / Treatment
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* Drug: Ibuprofen 600Mg Tablet
* Other: Standard Regimen | Tylenol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • All patients age 18-65 undergoing functional endoscopic sinus surgery +/- nasal airway surgery (septoplasty and/or inferior turbinate reduction). Exclusion Criteria: Not taking anti-coagulation medications including aspirin Clinical Diagnosis of aspirin-exacerbated respiratory disease Clinical Diagnosis of Cystic Fibrosis Clinical Diagnosis of Primary Ciliary Dyskinesia Inclusion of a Draf III frontal sinusotomy Clinical Diagnosis of Liver/Kidney Failure Clinical Diagnosis of Thrombocytopenia Clinical Diagnosis of Poorly controlled hypertension Clinical Diagnosis of Recent GI ulcers or gastritis Clinical Diagnosis of Chronic pain as defined by a narcotic prescription with 6 months or involvement in a pain management program Clinical Diagnosis of Primary Headache disorder The use of nasal decongestants in the post-operative period. The use of nasal packing or absorbable biomaterials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Tylenol Regimen<br>Patient will be given a standard regimen: Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed. | Other: Standard Regimen | Tylenol<br>* Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.<br>* Other names: Acetaminophen;|
| Active Comparator: Ibuprofen 600mg<br>Tylenol 1000 mg by mouth every 6 hours scheduled and ibuprofen 600 mg tablet by mouth every 8 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed. | Drug: Ibuprofen 600Mg Tablet<br>* ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.<br>* Other names: Advil, Motrin IB;Other: Standard Regimen | Tylenol<br>* Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.<br>* Other names: Acetaminophen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | Patients will be given a Visual Analogue scale to help document their level of pain from Post-operative days 0, 1, 2, 3, 4 ,5 and the first post-operative visit with the surgeon. The patient will measure their pain score each time they take medication. The pain scale called the Wong-Baker FACES pain rating scale is a 0-10 pain scale. 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. The numbers are added up to a sum and put into their perspective category known by the Otolaryngologist. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of bleeding | Any physician visits secondary to bleeding will be tabulated including ER and office visits. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSAIDs, post-operative pain, post-operative hemorrhage, Functional endoscopic sinus surgery