Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

February 18, 2022 updated by: Jared Inman, Loma Linda University

Quantifying Narcotic Use in Outpatient Otolaryngology Procedures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Surgical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Norco
Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control
Other Names:
  • Narcotic
  • Hydrocodone/Acetaminophen
ACTIVE_COMPARATOR: 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.
Drug: Ibuprofen
Ibuprofen as first line therapy every 6 hours as needed for pain control
Other Names:
  • Advil
  • NSAID
  • Motrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic Usage
Time Frame: First 7 days after surgery
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
Time Frame: Average reported pain for first 7 days after surgery
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
Time Frame: First 7 days after surgery
The average number of ibuprofen pills needed or used for pain control
First 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Jared Inman, MD, Loma Linda University Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 21, 2018

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

October 1, 2018

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (ACTUAL)

January 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5170252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Collected data will be analyzed and published. Meaningful data will be available through published material.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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