Nasal Sinus; InflammationEarly Phase 1NCT03822962

Pain Management Following Sinus Surgery

A Early Phase 1 study testing Ibuprofen 600Mg Tablet and Standard Regimen | Tylenol in people with Nasal Sinus; Inflammation and Opioid Abuse, run by University of Nebraska at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This Study evaluates the effect of adding Non-steroidal anti-inflammatories (NSAIDs) to the post-operative pain management of sinus surgery patients and wether or not this addition reduces or eliminates the need for narcotic pain medications. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Nasal Sinus; Inflammation, Opioid Abuse, Pain, Postoperative
What is being tested?: Ibuprofen 600Mg Tablet and Standard Regimen | Tylenol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesUnited States
Study dates: 7 Nov 2020to 30 May 2023
Phase: Early Phase 1

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 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All patients age 18-65 undergoing functional endoscopic sinus surgery +/- nasal airway surgery (septoplasty and/or inferior turbinate reduction).
Clinical Diagnosis of Liver/Kidney Failure
Clinical Diagnosis of Thrombocytopenia
Clinical Diagnosis of Poorly controlled hypertension
Clinical Diagnosis of Recent GI ulcers or gastritis
Clinical Diagnosis of Chronic pain as defined by a narcotic prescription with 6 months or involvement in a pain management program

Show all 9Show fewer

Clinical Diagnosis of Primary Headache disorder
The use of nasal decongestants in the post-operative period.
The use of nasal packing or absorbable biomaterials.

Who cannot join

Not taking anti-coagulation medications including aspirin
Clinical Diagnosis of aspirin-exacerbated respiratory disease
Clinical Diagnosis of Cystic Fibrosis
Clinical Diagnosis of Primary Ciliary Dyskinesia

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Cincinnati
Cincinnati, Ohio, 45267-0528
University of Nebraska Medical Center
Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: Post-operative Pain Management Following Functional Endoscopic Sinus Surgery

Patients will be instructed to take an NSAID regimen after surgery and will be instructed to take narcotics only for breakthrough pain.

Read the detailed description

National attention has been given to the concerning rise of opioid abuse in this country, with prescriptions for this medications more than quadrupaling in the last 17 years.

Little is known as to the appropriate use of opioid analgesics in the post-operative recovery of patients undergoing sinus surgery. Furthermore, most pain protocols include only Tylenol based opioid analgesics. No study has prospectively evaluated the volume of use of Tylenol based opioid analgesics and whether the addition of NSAIDS decreased the need for opioid analgesics.

This study will compare opioid use with and without the addition of NSAIDS following sinus surgery.

Post-operative opioid use is a great public health concern, relatively unstudied, and an area with an opportunity for potential intervention to significantly reduce risks, morbidity, and mortality to our postoperative patients by better formulating a postoperative pain management plan using evidence-based practices. Appropriate opioid prescribing practices can reduce the risk of addiction, drug overdose, death, and undertreated pain. By optimizing post-operative pain management protocols, the need for opioids following sinus surgery should be minimized.

Conditions: Nasal Sinus; Inflammation, Opioid Abuse, Pain, Postoperative
Being tested: Ibuprofen 600Mg Tablet, Standard Regimen | Tylenol
Keywords: NSAIDs, post-operative pain, post-operative hemorrhage, Functional endoscopic sinus surgery
Medical subject headings: Sinusitis, Opioid-Related Disorders, Pain, Postoperative, Postoperative Hemorrhage

What participants receive

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

Ibuprofen 600Mg TabletDrug
Also called Advil, Motrin IB
ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.
Standard Regimen | TylenolOther
Also called Acetaminophen
Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.

Study groups in NCT03822962
Study group	Role	What they receive
Standard Tylenol Regimen	Other	Patient will be given a standard regimen: Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed. Receives: Other: Standard Regimen \| Tylenol
Ibuprofen 600mg	Active comparator	Tylenol 1000 mg by mouth every 6 hours scheduled and ibuprofen 600 mg tablet by mouth every 8 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed. Receives: Drug: Ibuprofen 600Mg Tablet; Other: Standard Regimen \| Tylenol

What is being measured

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

Pain level
Patients will be given a Visual Analogue scale to help document their level of pain from Post-operative days 0, 1, 2, 3, 4 ,5 and the first post-operative visit with the surgeon. The patient will measure their pain score each time they take medication.
The pain scale called the Wong-Baker FACES pain rating scale is a 0-10 pain scale. 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. The numbers are added up to a sum and put into their perspective category known by the Otolaryngologist.
Measured: 1 week

Secondary outcomes (1)

Rate of bleeding
Any physician visits secondary to bleeding will be tabulated including ER and office visits.
Measured: 1 week

Timeline

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

7 Nov 202030 May 2023

First posted30 Jan 2019
Study start7 Nov 2020
Primary completion30 May 2023
Study completion30 May 2023

Why it stopped: Decrease in accrual during the COVID-19 pandemic and several sites withdrawing

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nasal Sinus; InflammationStudies of the same condition, open and under way.
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: Early Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: prospective, cohort study
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03822962
Sponsor's protocol ID: 0417-18-FB
Status last verified: Aug 2023
First submitted: 28 Jan 2019
Last updated: 6 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No