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Clinical Trials/NCT03783702
NCT03783702
Completed
Phase 4

Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery

Stanford University6 sites in 2 countries118 target enrollmentApril 4, 2019

Overview

Phase
Phase 4
Intervention
OxyCODONE 5 Mg (milligram) Oral Tablet
Conditions
Sinusitis
Sponsor
Stanford University
Enrollment
118
Locations
6
Primary Endpoint
Pain Severity
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over 250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids to patients recovering from ESS). It has been shown that these excess opioid medications contribute to prolonged use or abuse by the patient, family members, or friends. The purpose of this study is to better understand the pain management requirements of patients who undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS).

This prospective, randomized, multi-institutional controlled trial will aim to determine the degree to which pain following ESS can be adequately controlled by non-opioid medications. It will also determine whether post-ESS narcotic use can be avoided entirely, or at least significantly limited. Patients will be randomized into two groups, each of which will receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and the Brief Pain Inventory (BPI).

The results of this study will help to develop a standardized approach to pain management in the post-ESS setting and help to elucidate the role of non-opioid pain medications. The ultimate goal would be to positively affect opioid prescribing patterns among surgeons who perform ESS in order to significantly reduce the quantity of opioids prescribed to patients while continuing to adequately manage patients' pain.

Registry
clinicaltrials.gov
Start Date
April 4, 2019
End Date
December 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter Hwang

Principal Investigator, Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • English-speaking
  • Scheduled to undergo endoscopic sinus surgery for sinusitis (CRSwNP, CRSsNP, or RARS)
  • Can commit to follow up for at least one postoperative visit

Exclusion Criteria

  • Patients undergoing a septorhinoplasty (septoplasty permissible if patient will also undergo sinus surgery)
  • Doyle splints to be used
  • Alcohol or opioid use disorder
  • History of chronic pain disorders
  • Regular use of acetaminophen/NSAIDS (\>4x per week)
  • Patients who use narcotics or neuromodulating drugs (e.g. gabapentin, nortriptyline)more than 2x per week on average.
  • Gastrointestinal ulcers or bleeding
  • Chronic kidney disease/known decreased renal function (estimated glomerular filtration rate \<60)
  • Liver cirrhosis or other hepatic impairment
  • Prior adverse reaction to opioids or NSAIDS

Arms & Interventions

Experimental group

Patients in the experimental group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is ibuprofen (600mg tablet by mouth every 6 hours). Oxycodone (5mg tablet by mouth every 4 hours) will be the third-line medication to be used if acetaminophen and ibuprofen do not sufficiently control the pain.

Intervention: OxyCODONE 5 Mg (milligram) Oral Tablet

Experimental group

Patients in the experimental group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is ibuprofen (600mg tablet by mouth every 6 hours). Oxycodone (5mg tablet by mouth every 4 hours) will be the third-line medication to be used if acetaminophen and ibuprofen do not sufficiently control the pain.

Intervention: Ibuprofen 600 Mg (milligram) Oral Tablet

Experimental group

Patients in the experimental group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is ibuprofen (600mg tablet by mouth every 6 hours). Oxycodone (5mg tablet by mouth every 4 hours) will be the third-line medication to be used if acetaminophen and ibuprofen do not sufficiently control the pain.

Intervention: Acetaminophen 650 MG (milligram) Oral Tablet

Control group

Patients in the control group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is oxycodone (5mg tablet by mouth every 4 hours).

Intervention: OxyCODONE 5 Mg (milligram) Oral Tablet

Control group

Patients in the control group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is oxycodone (5mg tablet by mouth every 4 hours).

Intervention: Acetaminophen 650 MG (milligram) Oral Tablet

Outcomes

Primary Outcomes

Pain Severity

Time Frame: Average pain score will be collected for postoperative day 7

A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

Medication Log

Time Frame: Postoperative day 1 to 7

Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.

Secondary Outcomes

  • Severity of Epistaxis(Epistaxis severity will be collected for postoperative day 7)
  • Brief Pain Inventory (BPI) Score(Average BPI score will be collected for postoperative day 7)

Study Sites (6)

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