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Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

Primary Purpose

Outpatient Surgery, Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Norco
Ibuprofen
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Outpatient Surgery focused on measuring Thyroidectomy, Parotidectomy, Tympanoplasty, Mastoidectomy, Septoplasty, Sinus Surgery, Postoperative pain, Outpatient surgery

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loma Linda University Medical Center
  • Loma Linda University Surgical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Norco and Ibuprofen

Ibuprofen and Norco

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2018
Last Updated
February 18, 2022
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03404518
Brief Title
Patient Narcotic Requirements After Outpatient Otolaryngology Procedures
Official Title
Quantifying Narcotic Use in Outpatient Otolaryngology Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Outpatient Surgery, Pain, Postoperative
Keywords
Thyroidectomy, Parotidectomy, Tympanoplasty, Mastoidectomy, Septoplasty, Sinus Surgery, Postoperative pain, Outpatient surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Norco and Ibuprofen
Arm Type
Experimental
Arm Description
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.
Arm Title
Ibuprofen and Norco
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Norco
Other Intervention Name(s)
Hydrocodone/Acetaminophen, Narcotic
Intervention Description
Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
NSAID, Motrin, Advil
Intervention Description
Ibuprofen as first line therapy every 6 hours as needed for pain control
Primary Outcome Measure Information:
Title
Narcotic Usage
Description
The average number of narcotic pills needed or used for pain control
Time Frame
First 7 days after surgery
Secondary Outcome Measure Information:
Title
Patient Pain Level
Description
The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain.
Time Frame
Average reported pain for first 7 days after surgery
Title
Ibuprofen Usage
Description
The average number of ibuprofen pills needed or used for pain control
Time Frame
First 7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jared Inman, MD
Organizational Affiliation
Loma Linda University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Loma Linda University Surgical Hospital
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Collected data will be analyzed and published. Meaningful data will be available through published material.
Citations:
PubMed Identifier
19221238
Citation
Sommer M, Geurts JW, Stessel B, Kessels AG, Peters ML, Patijn J, van Kleef M, Kremer B, Marcus MA. Prevalence and predictors of postoperative pain after ear, nose, and throat surgery. Arch Otolaryngol Head Neck Surg. 2009 Feb;135(2):124-30. doi: 10.1001/archoto.2009.3.
Results Reference
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PubMed Identifier
17298314
Citation
Foghsgaard S, Foghsgaard J, Homoe P. Early post-operative morbidity after superficial parotidectomy: a prospective study concerning pain and resumption of normal activity. Clin Otolaryngol. 2007 Feb;32(1):54-7. doi: 10.1111/j.1365-2273.2007.01315.x.
Results Reference
background
PubMed Identifier
26422088
Citation
Song CM, Ji YB, Bang HS, Kim KR, Kim H, Tae K. Postoperative Pain After Robotic Thyroidectomy by a Gasless Unilateral Axillo-Breast or Axillary Approach. Surg Laparosc Endosc Percutan Tech. 2015 Dec;25(6):478-82. doi: 10.1097/SLE.0000000000000204.
Results Reference
background
PubMed Identifier
24735082
Citation
van Dijk JF, Kappen TH, Schuurmans MJ, van Wijck AJ. The Relation Between Patients' NRS Pain Scores and Their Desire for Additional Opioids after Surgery. Pain Pract. 2015 Sep;15(7):604-9. doi: 10.1111/papr.12217. Epub 2014 Apr 16.
Results Reference
background
PubMed Identifier
21840522
Citation
van Dijk JF, van Wijck AJ, Kappen TH, Peelen LM, Kalkman CJ, Schuurmans MJ. Postoperative pain assessment based on numeric ratings is not the same for patients and professionals: a cross-sectional study. Int J Nurs Stud. 2012 Jan;49(1):65-71. doi: 10.1016/j.ijnurstu.2011.07.009. Epub 2011 Aug 15.
Results Reference
background
PubMed Identifier
21724620
Citation
Gerbershagen HJ, Rothaug J, Kalkman CJ, Meissner W. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth. 2011 Oct;107(4):619-26. doi: 10.1093/bja/aer195. Epub 2011 Jun 30.
Results Reference
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PubMed Identifier
24521559
Citation
Ossiander EM. Using textual cause-of-death data to study drug poisoning deaths. Am J Epidemiol. 2014 Apr 1;179(7):884-94. doi: 10.1093/aje/kwt333. Epub 2014 Feb 11.
Results Reference
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Links:
URL
https://www.cdc.gov/mmwr/volumes/65/wr/mm655051e1.htm
Description
CDC report on opioid related deaths

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Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

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