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.
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
- Are there results?
- None posted in the registry
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
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- 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
About this study
Official title: Post-operative Pain Management Following Functional Endoscopic Sinus Surgery
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christie Barnes, MD, Principal investigator, University of Nebraska
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Pain Management Following Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT03822962
- Acronym / sponsor ID
- 0417-18-FB
- Conditions
- Nasal Sinus; Inflammation, Opioid Abuse, Pain, Postoperative
- Keywords
- NSAIDs, post-operative pain, post-operative hemorrhage, Functional endoscopic sinus surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decrease in accrual during the COVID-19 pandemic and several sites withdrawing
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 7 Nov 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Patients will be instructed to take an NSAID regimen after surgery and will be instructed to take narcotics only for breakthrough pain.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, cohort study
| Arm | Type | Receives |
|---|---|---|
| Standard Tylenol Regimen | Other | Other: Standard Regimen | TylenolPatient 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. |
| Ibuprofen 600mg | Active comparator | Drug: Ibuprofen 600Mg Tablet, Other: Standard Regimen | TylenolTylenol 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Ibuprofen 600Mg TabletAlso: Advil, Motrin IBibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen. | Drug | Ibuprofen 600mg |
| Standard Regimen | TylenolAlso: AcetaminophenTylenol 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. | Other | Ibuprofen 600mg, Standard Tylenol Regimen |
Primary outcome
Pain level
Time frame: 1 week
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.
1 secondary outcome
Rate of bleeding
Time frame: 1 week
Results and safety
The study was stopped early (reason given: Decrease in accrual during the COVID-19 pandemic and several sites withdrawing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- 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.
Christie Barnes, MD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 9 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Decrease in accrual during the COVID-19 pandemic and several sites withdrawing). Results are not available in the source record.
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 level (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2023.