Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

Pain, Postoperative Clinical Trial

Official title:

Quantifying Narcotic Use in Outpatient Otolaryngology Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404518
• Other study ID #: 5170252
• Status: Completed
• Phase: Phase 3
• Start date: February 21, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: February 2022
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Outpatient Surgery
• Pain, Postoperative

Intervention

Drug:
• Norco
Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control
• Ibuprofen
Ibuprofen as first line therapy every 6 hours as needed for pain control

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Loma Linda University Surgical Hospital	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Foghsgaard S, Foghsgaard J, Homøe 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narcotic Usage	The average number of narcotic pills needed or used for pain control	First 7 days after surgery
Secondary	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.	Average reported pain for first 7 days after surgery
Secondary	Ibuprofen Usage	The average number of ibuprofen pills needed or used for pain control	First 7 days after surgery

External Links

•   CDC report on opioid related deaths