Chronic Rhinosinusitis (Diagnosis)Phase 2/3NCT03055507
Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis
A Phase 2/3 study testing Ibuprofen 400 mg, Acetaminophen 650 mg and OxyCODONE 5 Mg Oral Tablet in people with Chronic Rhinosinusitis (Diagnosis), run by University of Washington at 1 site in United States.
Trial summary
Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually. Currently, there is no consensus, evidence-based post-operative pain regimen; with the majority of practitioners opting for a combination of acetaminophen and narcotics for pain… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Ibuprofen 400 mg, Acetaminophen 650 mg and OxyCODONE 5 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 31 Dec 2017
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with CRS scheduled to undergo functional endoscopic sinus surgery
- >18 years old
- Able to speak and comprehend written English
Who cannot join
- Contraindication to NSAID use (Chronic kidney disease, Peptic Ulcer disease, Aspirin exacerbated respiratory disorder (AERD), etc.)
- Previous history of bleeding disorder
- Sinus cancer
- Cystic Fibrosis
- Current use of anti-coagulant or anti-platelet medication (during and immediately after ESS)
- History of chronic pain, fibromyalgia, or opioid addiction
Show all 9Show fewer
- Excessive bleeding during the surgery as determined by the attending surgeon
- Contraindication to acetaminophen use
- Daily use of analgesics including ibuprofen, other NSAIDs, acetaminophen, narcotic medications or other analgesics.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis: A Prospective, Pilot, Cohort Study
Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually. Currently, there is no consensus, evidence-based post-operative pain regimen; with the majority of practitioners opting for a combination of acetaminophen and narcotics for pain control. Most rhinologists avoid NSAIDs due to decreased platelet aggregation and the theoretical risk of increased post-operative bleeding. No studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Additionally, there is a lack of information regarding the average narcotic requirement following ESS.
The purpose of this pilot prospective cohort study is to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen in the non-packed nose following ESS. This investigation will help to gain understanding of current opioid use in post-op sinus patients and assess the safety and effectiveness of post-operative ibuprofen administration on pain. The investigators aim to quantify the average narcotic use following ESS, as well as evaluate the effect of the addition of ibuprofen to the standard analgesic regimen on pain scores and post-operative epistaxis. The investigators hypothesize that the use of ibuprofen will decrease pain scores on a 10-cm visual analogue scale when compared with individuals who do not use ibuprofen post-operatively, this will lead to decreased opioid use in the post-operative period. Additionally, the investigators hypothesize no increase in post-operative bleeding rates, again based on a 10-cm visual analogue scale and bleeding events.
In summary, this will be the first study to the investigators knowledge to examine the effect of post-operative ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes, in ESS. By performing this pilot prospective cohort study, the investigators will be equipped to design and perform the optimal prospective, randomized study evaluating the effect of NSAID in ESS during the post-operative period. The overarching goal of this investigation is to decrease opioid use in post-operative pain control following ESS.
Read the detailed description
Opioid use and abuse is a major public health issue. US Surgeon General, Dr. Vikta Murthy, has recently called for investigation into evidence-based prescribing of opioids. Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually.1 Currently, there is no consensus for appropriate post-operative analgesic control after ESS. Many practitioners use a combination of acetaminophen and narcotics for pain control. Importantly, most rhinologists avoid the use of NSAIDs due to a theoretical concern for decreased platelet aggregation and the potential risk of increased post-operative hemorrhage. However, no studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Conceivably, if the investigators can improve post-operative pain control after ESS with using ibuprofen, then that may decrease standard prescriptions for narcotic analgesics. Given that 60% of narcotic overdose deaths are due to prescribed medications, this would help deliver improved pain control with less narcotic prescriptions. Therefore, the objective is to perform a pilot prospective cohort study to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen following ESS. This pilot study will provide critical baseline data for narcotic use, ibuprofen safety and ibuprofen analgesic impact to optimize the design of a future prospective, randomized study. Thus, specific aims are as follows:
Specific Aim 1: Patients with CRS will document their narcotic use in the first 7 days following sinus surgery. This will allow us to reform prescribing practices. Hypothesis: There will be a wide range of narcotic usage among post-op patients with the mean usage being less than the amount typically prescribed post-operatively.
Specific Aim 2: During enrollment the investigators will ask patients to self-select the study arm they would like to join (ibuprofen versus no ibuprofen) thus documenting willingness to participate, which is important in designing the future randomized study. Hypothesis: Most patients approached will be wiling to participate and will indicate willingness to be part of a similar randomized study.
Specific Aim 3a: Determine impact of ibuprofen on post-operative sinus surgery patients' pain level. The investigators will analyze patients with CRS that are set to undergo ESS in two cohorts (standard pain regimen and standard pain regimen plus ibuprofen) and assess postoperative pain at days 1, 3, and 7 by 10-cm visual analogue scale, amount of post-operative narcotic pain medication used, and number of days post-operatively taking narcotic medications, Hypothesis: Addition of ibuprofen will decrease post-operative pain and will decrease number of opioid pills used.
Specific Aim 3b: Determine impact of ibuprofens impact on post-operative epistaxis. Using the same patient cohorts, degree of epistaxis will be assessed utilizing standardized recording documents and a 10-cm visual analogue scale, as well as a previously used epistaxis grading system.2 The investigators will assess these outcomes on post-operative day 1, 3, and 7. Hypothesis: Addition of ibuprofen will demonstrate no increase in post-operative epistaxis compared to the control group.
At the study institution, approximately 250 endoscopic sinus cases are performed per year performed by two rhinologists. This will yield ample potential research subjects to complete the study. To the investigators knowledge, there is one previous study looking at the effect of peri-operative NSAIDs during ESS. This study found no increased risk in intraoperative or postoperative bleeding after administration of ketorolac. This will be the first study to examine the effect of post-operative oral ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Ibuprofen 400 mg, Acetaminophen 650 mg, OxyCODONE 5 Mg Oral Tablet
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mgDrug
Also called Motrin
Addition of ibuprofen to standard pain regimen.
Acetaminophen 650 mgDrug
Also called Tylenol, Paracetamol
Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral TabletDrug
Standard PRN medication offered post-operatively for breakthrough pain
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN (as needed) pain. Receives: Drug: Acetaminophen 650 mg; Drug: OxyCODONE 5 Mg Oral Tablet |
| Ibuprofen | Experimental | Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain. Receives: Drug: Ibuprofen 400 mg; Drug: Acetaminophen 650 mg; Drug: OxyCODONE 5 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analogue Scale (VAS)
10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
Measured: Post-operative day 1
Pain Visual Analogue Scale
10-cm visual analogue scale used to indicate level of post-operative pain. 10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
Measured: Post-operative day 3
Pain Visual Analogue Scale
10-cm visual analogue scale used to indicate level of post-operative pain. Scale from 0-10 with 0 indicating no pain and 10 indicating worst pain imaginable.
Measured: Post-operative day 7
Secondary outcomes (3)
Number of Opioid Pills
Number of opioid pills taken daily following surgery
Measured: Post-operative days 1-7
Bleeding Visual Analogue Scale
10-cm visual analogue scale used to indicate amount of nasal bleeding post-operatively. 0 = no bleeding, 10 = life-threatening bleeding
Measured: Post-operative days 1, 3, and 7
0-4 Bleeding Scale
Previously used 0-4 scale to indicate amount of nasal bleeding. 0 indicating no bleeding and 4 indicating life threatening bleeding.
Measured: Post-operative days 1, 3, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Miller, University of Washington
- Investigators
- Craig Miller, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055507
- Sponsor's protocol ID
- STUDY00000798
- Status last verified
- Mar 2023
- First submitted
- 10 Feb 2017
- Last updated
- 22 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis: A Prospective, Pilot, Cohort Study
- ClinicalTrials.gov ID
- NCT03055507
- Acronym / sponsor ID
- STUDY00000798
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 22 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually. Currently, there is no consensus, evidence-based post-operative pain regimen; with the majority of practitioners opting for a combination of acetaminophen and narcotics for pain control. Most rhinologists avoid NSAIDs due to decreased platelet aggregation and the theoretical risk of increased post-operative bleeding. No studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Additionally, there is a lack of information regarding the average narcotic requirement following ESS.
The purpose of this pilot prospective cohort study is to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen in the non-packed nose following ESS. This investigation will help to gain understanding of current opioid use in post-op sinus patients and assess the safety and effectiveness of post-operative ibuprofen administration on pain. The investigators aim to quantify the average narcotic use following ESS, as well as evaluate the effect of the addition of ibuprofen to the standard analgesic regimen on pain scores and post-operative epistaxis. The investigators hypothesize that the use of ibuprofen will decrease pain scores on a 10-cm visual analogue scale when compared with individuals who do not use ibuprofen post-operatively, this will lead to decreased opioid use in the post-operative period. Additionally, the investigators hypothesize no increase in post-operative bleeding rates, again based on a 10-cm visual analogue scale and bleeding events.
In summary, this will be the first study to the investigators knowledge to examine the effect of post-operative ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes, in ESS. By performing this pilot prospective cohort study, the investigators will be equipped to design and perform the optimal prospective, randomized study evaluating the effect of NSAID in ESS during the post-operative period. The overarching goal of this investigation is to decrease opioid use in post-operative pain control following ESS.
Detailed description
Opioid use and abuse is a major public health issue. US Surgeon General, Dr. Vikta Murthy, has recently called for investigation into evidence-based prescribing of opioids. Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually.1 Currently, there is no consensus for appropriate post-operative analgesic control after ESS. Many practitioners use a combination of acetaminophen and narcotics for pain control. Importantly, most rhinologists avoid the use of NSAIDs due to a theoretical concern for decreased platelet aggregation and the potential risk of increased post-operative hemorrhage. However, no studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Conceivably, if the investigators can improve post-operative pain control after ESS with using ibuprofen, then that may decrease standard prescriptions for narcotic analgesics. Given that 60% of narcotic overdose deaths are due to prescribed medications, this would help deliver improved pain control with less narcotic prescriptions. Therefore, the objective is to perform a pilot prospective cohort study to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen following ESS. This pilot study will provide critical baseline data for narcotic use, ibuprofen safety and ibuprofen analgesic impact to optimize the design of a future prospective, randomized study. Thus, specific aims are as follows:
Specific Aim 1: Patients with CRS will document their narcotic use in the first 7 days following sinus surgery. This will allow us to reform prescribing practices. Hypothesis: There will be a wide range of narcotic usage among post-op patients with the mean usage being less than the amount typically prescribed post-operatively.
Specific Aim 2: During enrollment the investigators will ask patients to self-select the study arm they would like to join (ibuprofen versus no ibuprofen) thus documenting willingness to participate, which is important in designing the future randomized study. Hypothesis: Most patients approached will be wiling to participate and will indicate willingness to be part of a similar randomized study.
Specific Aim 3a: Determine impact of ibuprofen on post-operative sinus surgery patients' pain level. The investigators will analyze patients with CRS that are set to undergo ESS in two cohorts (standard pain regimen and standard pain regimen plus ibuprofen) and assess postoperative pain at days 1, 3, and 7 by 10-cm visual analogue scale, amount of post-operative narcotic pain medication used, and number of days post-operatively taking narcotic medications, Hypothesis: Addition of ibuprofen will decrease post-operative pain and will decrease number of opioid pills used.
Specific Aim 3b: Determine impact of ibuprofens impact on post-operative epistaxis. Using the same patient cohorts, degree of epistaxis will be assessed utilizing standardized recording documents and a 10-cm visual analogue scale, as well as a previously used epistaxis grading system.2 The investigators will assess these outcomes on post-operative day 1, 3, and 7. Hypothesis: Addition of ibuprofen will demonstrate no increase in post-operative epistaxis compared to the control group.
At the study institution, approximately 250 endoscopic sinus cases are performed per year performed by two rhinologists. This will yield ample potential research subjects to complete the study. To the investigators knowledge, there is one previous study looking at the effect of peri-operative NSAIDs during ESS. This study found no increased risk in intraoperative or postoperative bleeding after administration of ketorolac. This will be the first study to examine the effect of post-operative oral ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Acetaminophen 650 mg, Drug: OxyCODONE 5 Mg Oral TabletStandard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN (as needed) pain. |
| Ibuprofen | Experimental | Drug: Ibuprofen 400 mg, Drug: Acetaminophen 650 mg, Drug: OxyCODONE 5 Mg Oral TabletAlternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with CRS scheduled to undergo functional endoscopic sinus surgery
- >18 years old
- Able to speak and comprehend written English
Key exclusion criteria (9 listed)
- Contraindication to NSAID use (Chronic kidney disease, Peptic Ulcer disease, Aspirin exacerbated respiratory disorder (AERD), etc.)
- Previous history of bleeding disorder
- Sinus cancer
- Cystic Fibrosis
- Current use of anti-coagulant or anti-platelet medication (during and immediately after ESS)
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 400 mgAlso: MotrinAddition of ibuprofen to standard pain regimen. | Drug | Ibuprofen |
| Acetaminophen 650 mgAlso: Tylenol, ParacetamolStandard analgesic provided post-operatively to patients undergoing sinus surgery | Drug | Control, Ibuprofen |
| OxyCODONE 5 Mg Oral TabletStandard PRN medication offered post-operatively for breakthrough pain | Drug | Control, Ibuprofen |
Primary outcome
Pain Visual Analogue Scale (VAS)
Time frame: Post-operative day 1
10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
Pain Visual Analogue Scale
Time frame: Post-operative day 3
10-cm visual analogue scale used to indicate level of post-operative pain. 10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
Pain Visual Analogue Scale
Time frame: Post-operative day 7
10-cm visual analogue scale used to indicate level of post-operative pain. Scale from 0-10 with 0 indicating no pain and 10 indicating worst pain imaginable.
3 secondary outcomes
Number of Opioid Pills
Time frame: Post-operative days 1-7
Bleeding Visual Analogue Scale
Time frame: Post-operative days 1, 3, and 7
0-4 Bleeding Scale
Time frame: Post-operative days 1, 3, and 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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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.
Craig Miller, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ibuprofen 400 mg, Acetaminophen 650 mg and OxyCODONE 5 Mg Oral Tablet in people with Chronic Rhinosinusitis (Diagnosis), run by University of Washington at 1 site 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 3 inclusion and 9 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 22 Mar 2023). 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 Visual Analogue Scale (VAS) (time frame: Post-operative day 1). The study lists 3 primary outcomes in all. 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 22 Mar 2023.