Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

NCT03404518 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 5170252
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 2

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.

Conditions

Outpatient Surgery; Pain, Postoperative

Keywords

Thyroidectomy; Parotidectomy; Tympanoplasty; Mastoidectomy; Septoplasty; Sinus Surgery; Postoperative pain; Outpatient surgery

Outcome Measures

Primary Outcomes (1)

• Narcotic Usage

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

  First 7 days after surgery

Secondary Outcomes (2)

• Patient Pain Level

  Average reported pain for first 7 days after surgery

• Ibuprofen Usage

  First 7 days after surgery

Study Arms (2)

Norco and Ibuprofen

EXPERIMENTAL

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

Ibuprofen and Norco

ACTIVE COMPARATOR

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

Interventions

Norco DRUG

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

Also known as: Hydrocodone/Acetaminophen, Narcotic

Norco and Ibuprofen

Ibuprofen DRUG

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

Also known as: NSAID, Motrin, Advil

Ibuprofen and Norco

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (2)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Loma Linda University Surgical Hospital

Loma Linda, California, 92354, United States

Location

Related Publications (7)

• 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.

  PMID: 19221238 BACKGROUND

• 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.

  PMID: 17298314 BACKGROUND

• 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.

  PMID: 26422088 BACKGROUND

• 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.

  PMID: 24735082 BACKGROUND

• 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.

  PMID: 21840522 BACKGROUND

• 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.

  PMID: 21724620 BACKGROUND

• 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.

  PMID: 24521559 BACKGROUND

Related Links

• CDC report on opioid related deaths

MeSH Terms

Conditions

Pain, Postoperative

Interventions

oxycodone-acetaminophen; Narcotics; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents

Limitations and Caveats

Some patients chose to not follow study instructions strictly and utilized ibuprofen therapy as primary analgesic treatment instead of their opioid medication.

Results Point of Contact

• Title: Khanh Nguyen, MD
• Organization: Loma Linda University Health System

khanguyen@llu.edu

909-558-8558

Study Officials

• Jared Inman, MD

  Loma Linda University Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 19, 2018
• Study Start: February 21, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 16, 2022
• Results First Posted: March 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)