SinusitisPhase 4NCT03783702

Pain Control Following Sinus Surgery

A Phase 4 study testing OxyCODONE 5 Mg (milligram) Oral Tablet, Ibuprofen 600 Mg (milligram) Oral Tablet and Acetaminophen 650 MG (milligram) Oral Tablet in people with Sinusitis and Opioid Use, run by Stanford University at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sinusitis, Opioid Use, Opioid Abuse
What is being tested?: OxyCODONE 5 Mg (milligram) Oral Tablet, Ibuprofen 600 Mg (milligram) Oral Tablet and Acetaminophen 650 MG (milligram) Oral Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 6 sitesin 2 countries
Study dates: 4 Apr 2019to 30 Dec 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 11Show fewer

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
Other contraindications to any drug classes in either group.

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States5 sites

NorthShore University Health System
Evanston, Illinois, 60201
Vanderbilt
Nashville, Tennessee, 37232
Mayo Clinic
Rochester, Minnesota, 55905
Stanford Health Care
Stanford, California, 94305
Albert Einstein
The Bronx, New York, 10461

Other trials in United States

Canada1 site

University of British Columbia
Vancouver

Other trials in Canada

About this study

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

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.

Conditions: Sinusitis, Opioid Use, Opioid Abuse, Narcotic Use, Otolaryngologic Disease, Postoperative Pain
Being tested: OxyCODONE 5 Mg (milligram) Oral Tablet, Ibuprofen 600 Mg (milligram) Oral Tablet, Acetaminophen 650 MG (milligram) Oral Tablet
Medical subject headings: Sinusitis, Opioid-Related Disorders, Otorhinolaryngologic Diseases, Pain, Postoperative, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxyCODONE 5 Mg (milligram) Oral TabletDrug
Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.
Ibuprofen 600 Mg (milligram) Oral TabletDrug
Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.
Acetaminophen 650 MG (milligram) Oral TabletDrug
All patients will receive acetaminophen as the first-line analgesic.

Study groups in NCT03783702
Study group	Role	What they receive
Experimental group	Experimental	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. Receives: Drug: OxyCODONE 5 Mg (milligram) Oral Tablet; Drug: Ibuprofen 600 Mg (milligram) Oral Tablet; Drug: Acetaminophen 650 MG (milligram) Oral Tablet
Control group	Active comparator	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). Receives: Drug: OxyCODONE 5 Mg (milligram) Oral Tablet; Drug: Acetaminophen 650 MG (milligram) Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Severity
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.
Measured: Average pain score will be collected for preoperative visit (the day before surgery)
Pain Severity
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.
Measured: Average pain score was collected for postoperative day 1
Pain Severity
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.
Measured: Average pain score will be collected for postoperative day 2
Pain Severity
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.
Measured: Average pain score will be collected for postoperative day 3
Pain Severity
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.
Measured: Average pain score will be collected for postoperative day 4
Pain Severity
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.
Measured: Average pain score will be collected for postoperative day 5
Pain Severity
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.
Measured: Average pain score will be collected for postoperative day 6
Pain Severity
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.
Measured: Average pain score will be collected for postoperative day 7
Medication Log
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.
Measured: Postoperative day 1 to 7

Secondary outcomes (16)

Brief Pain Inventory (BPI) Score
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Measured: BPI score will be collected at the preoperative visit
Brief Pain Inventory (BPI) Score
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Measured: Average BPI score will be collected for postoperative day 1
Brief Pain Inventory (BPI) Score
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Measured: Average BPI score will be collected for postoperative day 2
Brief Pain Inventory (BPI) Score
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Measured: Average BPI score will be collected for postoperative day 3
Brief Pain Inventory (BPI) Score
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Measured: Average BPI score will be collected for postoperative day 4
Brief Pain Inventory (BPI) Score
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Measured: Average BPI score will be collected for postoperative day 5
Brief Pain Inventory (BPI) Score
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Measured: Average BPI score will be collected for postoperative day 6
Brief Pain Inventory (BPI) Score
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Measured: Average BPI score will be collected for postoperative day 7
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Measured: Epistaxis severity will be collected at the preoperative visit
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Measured: Epistaxis severity will be collected for postoperative day 1
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Measured: Epistaxis severity will be collected for postoperative day 2
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Measured: Epistaxis severity will be collected for postoperative day 3
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Measured: Epistaxis severity will be collected for postoperative day 4
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Measured: Epistaxis severity will be collected for postoperative day 5
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Measured: Epistaxis severity will be collected for postoperative day 6
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Measured: Epistaxis severity will be collected for postoperative day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 201930 Dec 2020

First posted21 Dec 2018
Study start4 Apr 2019
Primary completion1 Jul 2020
Study completion30 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for SinusitisStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.
Masking: None (open label)
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03783702
Sponsor's protocol ID: 46384
Status last verified: Aug 2021
First submitted: 19 Dec 2018
Last updated: 1 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar;120(3):635-8. doi: 10.1002/lary.20777.
PubMed 20058315
Schwartz MA, Naples JG, Kuo CL, Falcone TE. Opioid Prescribing Patterns among Otolaryngologists. Otolaryngol Head Neck Surg. 2018 May;158(5):854-859. doi: 10.1177/0194599818757959. Epub 2018 Feb 20.
PubMed 29460670
Svider PF, Arianpour K, Guo E, Folbe E, Zuliani G, Lin H, Eloy JA, Folbe AJ. Opioid prescribing patterns among otolaryngologists: Crucial insights among the medicare population. Laryngoscope. 2018 Jul;128(7):1576-1581. doi: 10.1002/lary.27101. Epub 2018 Feb 15.
PubMed 29446449
Mohan S, Bhattacharyya N. Opioids and the Otolaryngologist: An Ambulatory Assessment. Otolaryngol Head Neck Surg. 2018 Jul;159(1):29-34. doi: 10.1177/0194599818765125. Epub 2018 Mar 20.
PubMed 29557264
Ayoub NF, Choby G, Turner JH, Abuzeid WM, Raviv JR, Thamboo A, Ma Y, Chandra RK, Chowdhury NI, Stokken JK, O'Brien EK, Shah S, Akbar N, Roozdar P, Nayak JV, Patel ZM, Hwang PH. Assessment of Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Sep 1;147(9):811-819. doi: 10.1001/jamaoto.2021.1839.
PubMed 34351376

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis
Not yet recruiting
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Sinusitis Chronic, Postoperative Care
Active, not recruitingObservational study
Endotypic Stability in CRS
Chronic Sinusitis
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps

All Sinusitis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery
ClinicalTrials.gov ID: NCT03783702
Acronym / sponsor ID: 46384
Conditions: Sinusitis, Opioid Use, Opioid Abuse, Narcotic Use, Otolaryngologic Disease, Postoperative Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Mayo Clinic, Vanderbilt University Medical Center, Albert Einstein College of Medicine, University of British Columbia, Endeavor Health
Study start: 4 Apr 2019 (actual)
Primary completion: 1 Jul 2020 (actual)
Study completion: 30 Dec 2020 (actual)
First posted: 21 Dec 2018 (actual)
Results: Posted 1 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.

Arm	Type	Receives
Experimental group	Experimental	Drug: OxyCODONE 5 Mg (milligram) Oral Tablet, Drug: Ibuprofen 600 Mg (milligram) Oral Tablet, Drug: Acetaminophen 650 MG (milligram) Oral TabletPatients 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.
Control group	Active comparator	Drug: OxyCODONE 5 Mg (milligram) Oral Tablet, Drug: Acetaminophen 650 MG (milligram) Oral TabletPatients 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxyCODONE 5 Mg (milligram) Oral TabletOxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.	Drug	Control group, Experimental group
Ibuprofen 600 Mg (milligram) Oral TabletPatients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.	Drug	Experimental group
Acetaminophen 650 MG (milligram) Oral TabletAll patients will receive acetaminophen as the first-line analgesic.	Drug	Control group, Experimental group

Primary outcome

Pain Severity
Time frame: Average pain score will be collected for preoperative visit (the day before surgery)
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.
Pain Severity
Time frame: Average pain score was collected for postoperative day 1
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.
Pain Severity
Time frame: Average pain score will be collected for postoperative day 2
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.
Pain Severity
Time frame: Average pain score will be collected for postoperative day 3
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.
Pain Severity
Time frame: Average pain score will be collected for postoperative day 4
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.
Pain Severity
Time frame: Average pain score will be collected for postoperative day 5
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.
Pain Severity
Time frame: Average pain score will be collected for postoperative day 6
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.
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.

16 secondary outcomes

Brief Pain Inventory (BPI) Score
Time frame: BPI score will be collected at the preoperative visit
Brief Pain Inventory (BPI) Score
Time frame: Average BPI score will be collected for postoperative day 1
Brief Pain Inventory (BPI) Score
Time frame: Average BPI score will be collected for postoperative day 2
Brief Pain Inventory (BPI) Score
Time frame: Average BPI score will be collected for postoperative day 3
Brief Pain Inventory (BPI) Score
Time frame: Average BPI score will be collected for postoperative day 4
Brief Pain Inventory (BPI) Score
Time frame: Average BPI score will be collected for postoperative day 5
Brief Pain Inventory (BPI) Score
Time frame: Average BPI score will be collected for postoperative day 6
Brief Pain Inventory (BPI) Score
Time frame: Average BPI score will be collected for postoperative day 7
Severity of Epistaxis
Time frame: Epistaxis severity will be collected at the preoperative visit
Severity of Epistaxis
Time frame: Epistaxis severity will be collected for postoperative day 1
Severity of Epistaxis
Time frame: Epistaxis severity will be collected for postoperative day 2
Severity of Epistaxis
Time frame: Epistaxis severity will be collected for postoperative day 3
Severity of Epistaxis
Time frame: Epistaxis severity will be collected for postoperative day 4
Severity of Epistaxis
Time frame: Epistaxis severity will be collected for postoperative day 5
Severity of Epistaxis
Time frame: Epistaxis severity will be collected for postoperative day 6
Severity of Epistaxis
Time frame: Epistaxis severity will be collected for postoperative day 7

Results and safety

Results posted to the registry on 1 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group	56	49
Control Group	62	51

Primary outcome: Pain Severity

Time frame: Average pain score will be collected for preoperative visit (the day before surgery). Mean (Standard Deviation). Unit: units on a scale

Measure	Experimental Group n = 49	Control Group n = 51
Value	12.4 (20.0)	8.5 (13.5)

Primary outcome: Pain Severity

Time frame: Average pain score was collected for postoperative day 1. Mean (Standard Deviation). Unit: units on a scale

Measure	Experimental Group n = 49	Control Group n = 51
Value	30.2 (26.6)	29.4 (26.0)

Primary outcome: Pain Severity

Time frame: Average pain score will be collected for postoperative day 2. Mean (Standard Deviation). Unit: units on a scale

Measure	Experimental Group n = 49	Control Group n = 51
Value	27.0 (24.8)	23.5 (23.2)

Primary outcome: Pain Severity

Time frame: Average pain score will be collected for postoperative day 3. Mean (Standard Deviation). Unit: units on a scale

Measure	Experimental Group n = 49	Control Group n = 51
Value	19.2 (22.6)	22.5 (19.0)

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the one week period after surgery for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Group	0 of 49 (0%)	0 of 49 (0%)	0 of 49
Control Group	0 of 51 (0%)	0 of 51 (0%)	0 of 51

Limitations and caveats (from the sponsor): The low levels of narcotic consumption observed may have precluded achieving significance in pain score comparisons across groups, as the pre-hoc power analysis predicted higher levels of opioid use Selection bias: 1) patient willingness to participate in an opioid-related study could serve as a source of bias 2) loss to follow up Lack of blinding and placebo were additional limitations

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20058315Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar;120(3):635-8. doi: 10.1002/lary.20777.
Background: PubMed 29460670Schwartz MA, Naples JG, Kuo CL, Falcone TE. Opioid Prescribing Patterns among Otolaryngologists. Otolaryngol Head Neck Surg. 2018 May;158(5):854-859. doi: 10.1177/0194599818757959. Epub 2018 Feb 20.
Background: PubMed 29446449Svider PF, Arianpour K, Guo E, Folbe E, Zuliani G, Lin H, Eloy JA, Folbe AJ. Opioid prescribing patterns among otolaryngologists: Crucial insights among the medicare population. Laryngoscope. 2018 Jul;128(7):1576-1581. doi: 10.1002/lary.27101. Epub 2018 Feb 15.
Background: PubMed 29557264Mohan S, Bhattacharyya N. Opioids and the Otolaryngologist: An Ambulatory Assessment. Otolaryngol Head Neck Surg. 2018 Jul;159(1):29-34. doi: 10.1177/0194599818765125. Epub 2018 Mar 20.
Derived from this study: PubMed 34351376Ayoub NF, Choby G, Turner JH, Abuzeid WM, Raviv JR, Thamboo A, Ma Y, Chandra RK, Chowdhury NI, Stokken JK, O'Brien EK, Shah S, Akbar N, Roozdar P, Nayak JV, Patel ZM, Hwang PH. Assessment of Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Sep 1;147(9):811-819. doi: 10.1001/jamaoto.2021.1839.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Severity (time frame: Average pain score will be collected for preoperative visit (the day before surgery)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03783702, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021; AzTrials last refreshed its copy on 27 Oct 2026.