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Completed

NCT Number: NCT03404518

Patient Narcotic Requirements After 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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Loma Linda University Medical Center, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Norco

Drug

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

Other names: Hydrocodone/Acetaminophen, Narcotic

Ibuprofen

Drug

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

Other names: NSAID, Motrin, Advil

Primary outcomes

  1. Narcotic Usage

    Time frame: First 7 days after surgery

    The average number of narcotic pills needed or used for pain control

Secondary outcomes

  1. 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.

  2. Ibuprofen Usage

    Time frame: First 7 days after surgery

    The average number of ibuprofen pills needed or used for pain control

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Quantifying Narcotic Use in Outpatient Otolaryngology Procedures

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 19, 2018
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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