Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-21

Study Completion Date

2018-10-01

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.

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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.

Conditions

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Outpatient Surgery Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Norco

Intervention Type DRUG

Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control

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.

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Ibuprofen as first line therapy every 6 hours as needed for pain control

Interventions

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Norco

Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control

Intervention Type DRUG

Ibuprofen

Ibuprofen as first line therapy every 6 hours as needed for pain control

Intervention Type DRUG

Other Intervention Names

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Hydrocodone/Acetaminophen Narcotic NSAID Motrin Advil

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes