Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Quantifying Narcotic Use in Outpatient Otolaryngology Procedures

Conditions
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Outpatient Surgery, Pain, Postoperative

Intervention / Treatment
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* Drug: Norco
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing one of the following outpatient procedure: Septoplasty Unilateral or Bilateral Functional endoscopic sinus surgery Tympanomastoidectomy Tympanoplasty Total or Partial Thyroidectomy Parathyroidectomy Parotidectomy. Age >18 years and < 89 years Exclusion Criteria: Age < 18 years or > 89 years Post operative hospital admission Allergy to Hydrocodone Allergy or contraindication to Ibuprofen or NSAIDs Pregnancy Hepatic disease Chronic kidney disease Sickle cell anemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norco and Ibuprofen<br>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. | Drug: Norco<br>* Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control<br>* Other names: Narcotic;|
| Active Comparator: Ibuprofen and Norco<br>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. | Drug: Ibuprofen<br>* Ibuprofen as first line therapy every 6 hours as needed for pain control<br>* Other names: Advil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Usage | The average number of narcotic pills needed or used for pain control | First 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | The average number of ibuprofen pills needed or used for pain control | First 7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroidectomy, Parotidectomy, Tympanoplasty, Mastoidectomy, Septoplasty, Sinus Surgery, Postoperative pain, Outpatient surgery