Clinical trial NCT03055507
Conditions: Chronic Rhinosinusitis (Diagnosis)
Sponsor: University of Washington
Start date: 2017-04-01; Completion date: 2017-12-31
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief 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 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.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Ibuprofen 400 mg intervention 2: Acetaminophen 650 mg intervention 3: OxyCODONE 5 Mg Oral Tablet
Intervention descriptions: intervention 1: Addition of ibuprofen to standard pain regimen. intervention 2: Standard analgesic provided post-operatively to patients undergoing sinus surgery intervention 3: Standard PRN medication offered post-operatively for breakthrough pain

Protocol documents:
Prot_SAP_000.pdf: 
Principal Investigator/Program Director (Last, first, middle): Miller, Craig 
 
1 
Research Strategy 
Study title: Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis 
 
NCT number: NCT03055507 
 
Date: October 12, 2022


Principal Investigator/Program Director (Last, first, middle): Miller, Craig 
 
2 
Research Strategy 
 
RESEARCH STRATEGY 
 
(a) Significance  
 
Chronic rhinosinusitis (CRS) is a common condition affecting up to 10% of the population and 
characterized by diffuse sinonasal inflammation leading to nasal congestion, drainage, facial pain, 
and hyposmia or anosmia. Typical management consists of appropriate medical therapy, including 
antibiotics, topical and systemic steroids and saline irrigations. In persistent or recalcitrant cases, 
surgical treatment may be required. Functional endoscopic sinus surgery (FESS) is a commonly 
performed procedure for patients with CRS. The technique uses a minimally invasive approach to 
open the sinus cavities and allow for clearance of mucous and infection through widening of the 
natural ostia of the sinuses. The procedure itself is quite safe and is typically performed on an 
outpatient basis. FESS is becoming more and more common with current estimates of 250,000 cases 
performed in the United States every year.1 Care in the immediate post-operative period varies from 
surgeon to surgeon, but typically includes nasal saline irrigations, antibiotics, early post-operative 
debridement and pain management with acetaminophen and oxycodone. Due to the theoretical risk 
of decreased platelet aggregation and possible increased bleeding tendency, most practitioners 
typically avoid the use of NSAIDs for post-operative analgesia. However, no study has been 
performed to assess this risk. In fact, previous studies have examined the use of preoperative 
ketorolac in patients undergoing FESS and found no increased risk of hemorrhage intra-operatively or 
post-operatively.2  Thus, the purpose of this proposed study is to perform a pilot study to investigate 
key logistics for a future study to assess safety and effectiveness of ibuprofen in the post-FESS 
patient with the hopes of decreasing narcotic use after FESS.  
 
The nidus for development of this study to standardize post-operative analgesia reflects the 
opioid epidemic in the United States and physician contribution to opioid related deaths. Opioids are 
now responsible for more deaths than suicide and motor vehicle accidents combined. The majority of 
these deaths (60%) occur in patients receiving prescriptions based on current prescribing guidelines 
by medical boards.3 A recent public health report by United States Surgeon General, Dr. Vivek H. 
Murthy, MD, MBA, calls for immediate efforts on gathering evidence-based information on appropriate 
opioid prescribing practices.4 Therefore, efforts are needed to refine the current practices of American 
physicians in regards to prescribing opioids. Multimodal analgesia, and demonstration of safety, is 
necessary to help curb the widespread, and perhaps, overuse of opioids among treated patients. 
 
In this proposal, our goal is to perform a pilot, prospective cohort study to evaluate the use of 
narcotics in sinus surgery and the effect of ibuprofen in the non-packed nose following FESS. The 
goals will be to quantify the average number of opioid pills used after FESS and assess the impact of 
ibuprofen in the post-operative period on pain and epistaxis outcomes. This work will lay the 
foundation and allow us to design and perform a future optimal prospective, randomized study. This 
study 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. 
 
By gaining an understanding of the average number of opioids used, and the ability to 
decrease that need with addition of other analgesics, we can work to decrease current opioid 
prescribing practices and work towards curbing the current opioid epidemic plaguing the United 
States.  
 


Principal Investigator/Program Director (Last, first, middle): Miller, Craig 
 
3 
Research Strategy 
We acknowledge early in this proposal the difficulty of performing a randomized, double-
blinded placebo controlled trial. Specifically, at this point the effect size on analgesia and epistaxis 
post-FESS is unknown, thus appropriate sample size estimate calculations cannot be performed. 
Therefore, we plan on performing this study as a cohort study. This pilot study will serve multiple 
purposes; first it will allow us to determine the adequate sample size needed to observe a significant 
effect. Additionally, we will be able to document patient’s willingness to participate in a future 
randomized study thus allowing for design and execution of the optimal prospective, randomized 
study.  
 
 
(b) Innovation  
 
 
To our knowledge, there has not been a prospective study in CRS patients following 
endoscopic sinus surgery that examines the use over the counter NSAIDs, namely ibuprofen, in the 
post-operative period. One previous study has shown that perioperative IV ketorolac improves 
immediate post-operative pain scores and does not increase epistaxis or hemorrhage.2 The 
widespread use of ibuprofen as an over-the-counter analgesic, as well as its safety and efficacy as an 
anti-inflammatory, necessitates further studies to assess safety and evidence-based studies in this 
population. The need for improved non-narcotic analgesia post-FESS is analogous to the recent 
paradigm shift in post-tonsillectomy pediatric patients where many national and international 
guidelines now discourage post-tonsillectomy narcotics and instead advocate ibuprofen and 
acetaminophen.5-8 
 
 
In addition to the paucity of studies examining the use of NSAIDs in post-operative FESS 
patients, there are no validated scoring systems for post-operative epistaxis. This pilot study will 
utilize a previously used epistaxis scoring system9, as well as a 10-cm visual analogue scale for 
patients to self-report their level of post-operative bleeding. This design will afford us two 
opportunities; first, we will be able to perform a power analysis for our future randomized control trial 
and second, we will be able to validate the previously used 4 point epistaxis grading scale.  
 
 
Few studies in the otolaryngology literature have sought to utilize over-the-counter medication 
to help curb the opioid use following surgery. With the increased incidence of opioid abuse in this 
country, the need to curb opioid prescribing practices and use is of the utmost importance. The efforts 
of this study will lay the foundation to help improve knowledge and understanding of non-narcotic 
analgesics in an effort to decrease patient use of opioids and resultant dependency or abuse.  
 
(c) Approach  
  
 
This is a prospective cohort pilot study to evaluate the use of narcotics in sinus surgery and the effect 
of ibuprofen on pain and epistaxis 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 our specific aims are as follows: 
 
Aim 1: Measure the number of narcotic pills used during the first 7 days following sinus surgery for 
CRS.  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. 
 
 
 


Principal Investigator/Program Director (Last, first, middle): Miller, Craig 
 
4 
Research Strategy 
The second aim seeks to evaluate the effect of ibuprofen on post-operative pain scores, as well as 
epistaxis rates. This information will be used to help determine the effect size for our outcome 
measures that will be needed for a power calculation for a future randomized trial.   
 
Aim 2a: Determine impact of ibuprofen on post-operative sinus surgery patients’ pain level.  We 
will analyze patients with CRS that are set to undergo FESS 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 decrease the number of opioid pills used. 
 
Aim 2b: Determine impact of ibuprofen on post-operative epistaxis following sinus surgery. In the 
same cohorts as above, we will measure degree of post-operative epistaxis using a 10-cm visual 
analogue scale, as well as a 4 point previously used epistaxis grading scale. This will allow us to 
both determine effect of ibuprofen on epistaxis and potentially validate a previously used epistaxis 
grading scale. Hypothesis: Addition of ibuprofen will not impact post-operative epistaxis.  
 
 
Aim 3 will seek to estimate the willingness of individuals to participate in a future randomized double-
blinded placebo control trial.  
 
Aim 3: During enrollment we will ask patients to self-select the study arm they would like to join 
(with or without ibuprofen) and document willingness to participate in a future study given the 
scenario that they would be randomized to the treatment by a “coin flip”. Hypothesis: greater than 
50% of patients approached will be wiling to participate and will indicate willingness to be part of a 
similar randomized study. 
 
Study Design: Prospective self-selected cohort pilot study 
 
Study Location: Rhinology Clinic (Drs. Davis and Humphreys) at the University of Washington 
Medical Center 
 
Subject approach: 
 
 
All eligible patients set to undergo sinus surgery will be screened and approached in clinic at 
the appointment where surgery consent is completed.  We will use the following criteria: 
 
Inclusion Criteria: 
• Patients with CRS scheduled to undergo functional endoscopic sinus surgery 
• >18 years old 
• Able to speak and comprehend written English 
 
Exclusion criteria:  
• Contraindication to NSAID use (CKD, PUD, Sampter’s triad, etc.) 
• Previous history of bleeding disorder 
• Sinus cancer 
• Cystic Fibrosis 
• History of chronic pain, fibromyalgia, or opioid addiction 


Principal Investigator/Program Director (Last, first, middle): Miller, Craig 
 
5 
Research Strategy 
• Excessive bleeding during the surgery as determined by the attending surgeon 
 
 
 
All patients with chronic rhinosinusitis who are scheduled to undergo FESS will be approached 
at their pre-operative clinic visit to inquire about interest in participating in the clinical study. If willing 
to participate, patients will be asked whether they would be interested in taking ibuprofen post-
operatively, as a scheduled medication, in addition to the standard pain regimen consisting of 
acetaminophen and oxycodone taken as needed. If patients are interested, they will be placed in the 
intervention group. If they are not interested in taking ibuprofen, but willing to participate in the study, 
they will be placed in the control group. If interested in participating, patients will be asked whether 
they would like to use REDcap, a mature, HIPAA secure web application for building and managing 
online surveys and databases, versus paper journals to document their outcome measures. If they 
elect to use REDcap we will take their email address to allow for communication. If they elect to use 
paper journal, we will take their phone number to allow for reminder “courtesy” calls on post-operative 
days 1, 3, and 7.  
 
All post-operative FESS patients are seen at two weeks after their surgery. We will collect their 
journal containing pain and epistaxis scores at that time. No further intervention or study will be done 
on these patients. In order to promote sufficient recording of daily VAS scores and other outcome 
measures we will provide patient remuneration with a $50 gift card.  
 
Sample Size 
Due to lack of studies examining epistaxis outcomes, there is no validated outcome measure 
or known statistically significant effect size. This study will help us determine that effect size, as well 
as validate a previously used epistaxis severity scoring system. We will plan to enroll 30 patients in 
each arm of the study.  
  
Measurements 
 
Descriptive characteristics will be gathered at the initial visit. 
• Demographics: age, gender, and race. 
• Contact information: standard information to arrange interviews and post-operative phone 
calls, and dispense remuneration  
• CT severity: will use the Lund-Mackay CT staging system to assess disease severity. 
• Lund-Kennedy endoscopic score (0-20): endoscopic appearance will be collected and scored 
• Additional predictors of CRS outcomes: nasal polyposis, asthma, aspirin sensitivity, smoking, 
allergies, depression. 
• Functional Comorbidity Index: Previously validated in CRS as a tool for assessment of impact 
of comorbidities on CRS-associated quality of life 
Subjective and objective details of the individual’s sinus surgery: 
• Operative time 
• Estimated blood loss 
• Extent of sinus surgery performed 
• Surgical complications  
Subjective and objective clinical measures will be evaluated during the post-operative period  
• Patient reported opioid use: Number of opioid pills taken as noted in the daily diary 
• 10-cm Visual Analogue Scale for pain and epistaxis: recorded daily in diary. Will use 
assessments from post-operative days 1, 3, and 7 


Principal Investigator/Program Director (Last, first, middle): Miller, Craig 
 
6 
Research Strategy 
• 0-4 point epistaxis grading scale: Previously used scoring system of 0-4 to be collected daily 
over the first 72 hours9  
• Number of gauze changes on moustache dressing over the first 72 hours: Used as a 
subjective, clinically significant estimate of post-operative bleeding. If patient no longer 
required moustache dressing during this period, this will be recorded as zero (0).  
 
 
Treatment Arms 
 
This cohort study will allow patients to choose their treatment arm. If interested in taking 
ibuprofen post-operatively, the patient will be stratified into the experiment arm. This will consist of the 
standard pain regimen (acetaminophen 650 mg q4hr PRN and oxycodone 5mg q3hr PRN) with 
addition of ibuprofen 800 mg q8hr scheduled. If the individual is not interested in being prescribed 
ibuprofen, but is still willing to participate in the study, s/he will be stratified into the control arm with 
the standard pain regimen as described above.  
 
Data Analysis 
 
Data analysis will be performed using an unpaired t-test to compare our primary outcome 
measures of 10-cm visual analogue scales (VAS) for post-operative pain and epistaxis from post-
operative days 1, 3, and 7. For all other post-operative outcome measures, we will use t-tests to 
compare the two treatment arms. Based on our comparison of post-operative epistaxis VAS, we will 
seek to perform validation of the 0-4 point epistaxis grading scale previously described by Kastl et al.9 
 
Data Protection 
 
All study participants will be protected under HIPAA policies. Individuals will be de-identified 
following completion of study participation. All records will be kept on an encrypted computer in 
password-protected documents. Written diaries will be transcribed into excel files and kept in a locked 
file cabinet until manuscript submission. All protected health information will be protected under 
HIPAA protocol and Institutional IRB.  
 
Limitations and Potential Pitfalls: 
 
We acknowledge a number of limitations with our proposed study: First, this is a pilot study 
and is not designed to evaluate a definitive outcome related to post-operative pain reduction and 
epistaxis with ibuprofen. The risk of severe post-operative epistaxis following ESS is extremely low 
and, due to the safety and low risk of ibuprofen, we will likely not observe a statistically relevant 
amount of epistaxis in our sample. This will be helpful for determining adequate sample size in future 
studies. We also acknowledge the difficulty with expecting patients to record their outcome measures 
daily following surgery. We hope that by providing sufficient remuneration, as well as reminder phone 
calls or emails on post-operative days 1, 3, and 7, we will have adequate recording to evaluate our 
aims. Finally, study recruitment will be a potential challenge. If, as the study progresses, it does not 
appear that we are meeting our expected target enrollment, we will consider opening up recruitment 
to additional sites of practice both within our institution and to surrounding rhinology practices.  
 
Feasibility:  
 
At our institution, we see a large number of patients with CRS and perform approximately 250 
endoscopic sinus cases per year. Given this information, and the expectation that 75% of patients will 
be willing to participate in the study since they get to self-select their treatment arm, we expect this 
study to take 4-6 months to recruit 60 subjects (30 in each treatment arm).  


Principal Investigator/Program Director (Last, first, middle): Miller, Craig 
 
7 
Research Strategy 
 
 
Future Directions 
 
 
Once this study is complete, we will have a better understanding of the sample size necessary 
to observe a statistically significant effect size for our proposed outcomes. Additionally, we will have a 
stronger understanding of individual’s willingness to participate in a similarly designed RCT. At that 
point, we will be equipped to design and implement a well designed and appropriately powered 
randomized, double-blinded placebo controlled trial. We do acknowledge that the results of this study 
will be that of a single institution that does not pack the nose following ESS. A true randomized trial 
would want to look multi-institutionally with practitioners that utilize a variety of post-op regimens 
including nasal packing and non-packing.  
 
 
1. 
Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and 
perioperative outcomes. The Laryngoscope 2010; 120:635-638. 
2. 
Moeller C, Pawlowski J, Pappas AL, Fargo K, Welch K. The safety and efficacy of intravenous 
ketorolac in patients undergoing primary endoscopic sinus surgery: a randomized, double-
blinded clinical trial. International forum of allergy & rhinology 2012; 2:342-347. 
3. 
Manchikanti L, Helm S, 2nd, Fellows Bet al. Opioid epidemic in the United States. Pain 
physician 2012; 15:ES9-38. 
4. 
Murthy VH. A Promise Fulfilled-Addressing the Nation's Opioid Crisis Collectively. Public 
health reports 2016; 131:387-388. 
5. 
Riggin L, Ramakrishna J, Sommer DD, Koren G. A 2013 updated systematic review & meta-
analysis of 36 randomized controlled trials; no apparent effects of non steroidal anti-
inflammatory agents on the risk of bleeding after tonsillectomy. Clinical otolaryngology : official 
journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & 
Cervico-Facial Surgery 2013; 38:115-129. 
6. 
Lauder G, Emmott A. Confronting the challenges of effective pain management in children 
following tonsillectomy. International journal of pediatric otorhinolaryngology 2014; 78:1813-
1827. 
7. 
Kelly LE, Sommer DD, Ramakrishna Jet al. Morphine or Ibuprofen for post-tonsillectomy 
analgesia: a randomized trial. Pediatrics 2015; 135:307-313. 
8. 
Baugh RF, Archer SM, Mitchell RBet al. Clinical practice guideline: tonsillectomy in children. 
Otolaryngology--head and neck surgery : official journal of American Academy of 
Otolaryngology-Head and Neck Surgery 2011; 144:S1-30. 
9. 
Kastl KG, Reichert M, Scheithauer MOet al. Patient comfort following FESS and Nasopore(R) 
packing, a double blind, prospective, randomized trial. Rhinology 2014; 52:60-65. 
 
 

ICF_001.pdf: 
Effect of Post-operative Ibuprofen after Surgery for Chronic Rhinosinusitis: 11/25/16 
 
1 of 4 
UNIVERSITY OF WASHINGTON 
CONSENT FORM 
 
Effect of Post-operative Ibuprofen after Surgery for Chronic Rhinosinusitis 
 
Researchers:   
Craig Miller, MD 
Resident 
Otolaryngology – Head & 
Neck Surgery 
206-314-8781 
Greg Davis, MD, MPH 
Associate Professor 
Otolaryngology – Head & 
Neck Surgery 
206-543-5230 
Ian Humphreys, DO 
Assistant Professor 
Otolaryngology – Head & 
Neck Surgery 
206- 583-1863 
 
Researchers’ statement 
We are asking you to be in a research study.  The purpose of this consent form is to give you the 
information you will need to help you decide whether to be in the study or not.  Please read the 
form carefully.  You may ask questions about the purpose of the research, what we would ask 
you to do, the possible risks and benefits, your rights as a volunteer, and anything else about the 
research or this form that is not clear.  When we have answered all your questions, you can 
decide if you want to be in the study or not.  This process is called “informed consent.”  We will 
give you a copy of this form for your records. 
 
PURPOSE OF THE STUDY 
Chronic rhinosinusitis (CRS) is a common clinical disease. Following sinus surgery, patients are 
typically prescribed a combination of acetaminophen, also known as Tylenol, and an opiate 
narcotic medication, such as oxycodone, or a single combination pill of both medications. We 
are interested in investigating the impact of other pain medications on sinus surgery pain. One 
medication specifically, ibuprofen, also known as Motrin or Advil, is an over-the-counter 
medication. We are conducting a study investigating the use of ibuprofen in the post-operative 
period following sinus surgery. We are hoping to find out if ibuprofen is a safe and effective 
option for pain control in post-operative sinus surgery patients as this could help to reduce opiate 
exposure and prescribing. Currently, surgeons who perform sinus surgery avoid the use of 
ibuprofen due to a theoretical risk of increased bleeding following sinus surgery. We aim to 
perform a well designed study to evaluate this theoretical risk.  
 
This investigation will be aimed at reducing the number of opioid pills prescribed and taken 
following sinus surgery. The first step in this process is evaluating the effect of ibuprofen on pain 
levels following surgery. This study will have two arms and participation in either arm is your 
choice entirely. One arm will consist of the standard pain regimen without the addition of 
ibuprofen, the other will have the same regimen with the addition of ibuprofen 400 mg every 6 
hours while awake until cessation of need for scheduled pain medication.   
 
 


Effect of Post-operative Ibuprofen after Surgery for Chronic Rhinosinusitis: 11/25/16 
 
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STUDY PROCEDURES 
We will also ask you to let us record information from your medical record for research.  We 
want to record information about your medical history, nasal cultures, previous surgeries, CT 
scans of your sinuses, and any questionnaires that you complete in the clinic related to your 
chronic sinus disease. 
 
We are giving you information about this study because you are being treated for chronic sinus 
disease.  Treatment for you sinus disease will be decided by your physician and is independent of 
this study. If you are willing to participate, we will have you decide in which arm you would like 
to be enrolled, standard or ibuprofen. Following sinus surgery, we will have you complete a short 
questionnaire each day for seven days. You have the choice of using a paper diary to complete 
this or using an online, secure website. If you elect to use the paper diary, you will receive a 
quick reminder call on the 1st, 3rd and 7th day following surgery to remind you to complete your 
questionnaire. If you choose the online recording tool, an email with a link to the questionnaire 
will be sent to you daily for the first seven days following surgery. The table below outlines the 
pain management schedule for the two arms of the study. Acetaminophen or acetaminophen and 
ibuprofen combination will be taken on a scheduled basis while you are awake until your pain is 
managed well enough to no longer needed scheduled pain medication. The “control group” is the 
normal pain control that will be prescribed even if you are not interested in participating in the 
study. The addition of ibuprofen is the experimental aspect of this study.  
Control group (normal pain control regimen) 
Study group (ibuprofen) 
Acetaminophen 650 mg q6 hrs 
Acetaminophen 650 mg q6 hrs 
Oxycodone 5 mg q3hrs PRN 
Oxycodone 5 mg q3hrs PRN 
 
Ibuprofen 400 mg q6hrs (alternating every 3 hrs with 
acetaminophen) 
 
 
All sinus surgery patients are seen in clinic approximately two weeks following surgery. At that 
time, we will have you bring back your diary and will give you a $20 gift card for your 
participation in the study.  The diary must be complete to receive the gift card. Additionally, at 
your first post-operative visit, we ask that you bring in your remaining oxycodone pills for us to 
count how many you have left and calculate how many you took during the post-operative 
period. All remaining pills will be returned to you. All patients involved in the study will be seen 
by a study team member at the first post-op visit.  
 
RISKS, STRESS, OR DISCOMFORT 
Risks for this study include all risks of sinus surgery that your surgeon discussed with you prior 
to signing your surgical consent. For the study specifically, the standard pain regimen arm has no 
further risks beyond sinus surgery. Ibuprofen is a commonly used medication, but there are a 
number of potential adverse effects including nausea, dyspepsia, gastrointestinal 
bleeding/ulceration, raised liver enzymes, diarrhea, constipation, increased nose bleeding, 
headache, dizziness, rash, and hypertension. The short duration and low dose of the medication 
used in this study make these adverse effects unlikely. Currently, there is not enough data to 


Effect of Post-operative Ibuprofen after Surgery for Chronic Rhinosinusitis: 11/25/16 
 
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draw conclusions on whether the use of ibuprofen is safe in this population and this is why we 
are performing the study. Due to this lack of substantial data, there is a possibility that there may 
be increased bleeding following surgery. We anticipate that this will be minimal, but we have 
provided contact information for our clinic and on-call physician if you have any concerns post-
operatively. If you elect to be in the control arm, we will ask that you do not take ibuprofen in 
the post-operative period. This may place you at an increased for opioid exposure compared to 
what you would experience if you did not participate in this study. There is a risk to your 
confidentiality when your medical records are accessed and used for research. Information about 
how we will protect you health information is outlined in the Confidentiality section below.  
Not all patients are eligible for this study. Exclusion criteria includes: any contraindication to 
ibuprofen, or its class of medications known as NSAIDS (including but not limited to chronic 
kidneys disease, peptic ulcer disease, Sampter’s triad), previous history of bleeding disorder, 
sinus cancer, cystic fibrosis, current use of blood thinning medication, history of chronic pain 
condition, fibromyalgia, or opioid addicition, contraindication to acetaminophen, also known as 
Tylenol, or daily use of pain medication for any other reason including ibuprofen, other NSAIDs, 
acetaminophen/Tylenol, opioid medication or other analgesics. If you feel any of these apply to 
you, please notify the person discussing this study with you or your surgeon. 
 
BENEFITS OF THE STUDY 
We do not know if ibuprofen will help the subject need less opioid medication. The subject will 
not benefit directly but we hope that this study may help others in the future.We will be using 
information gained from this study to advance knowledge and understanding of sinus disease, as 
well as evidence-based prescribing on narcotic medication.  
 
CONFIDENTIALITY OF RESEARCH INFORMATION 
The researchers will keep your study information confidential. We will assign a study code to 
your study information. We will keep any information that will identify you in a secure location, 
separate from the study information. If we publish the results of this study, we will not use any 
information that will identify you. We may use the study information for other studies after we 
destroy any link to your identity. 
Government and university staff sometimes review studies such as this one to make sure they are 
being done safely and legally.  If a review of this study takes place, your records may be 
examined.  The reviewers will protect your privacy.  The study records will not be used to put 
you at legal risk of harm. 
 
OTHER INFORMATION 
Taking part in this study is voluntary.  You may refuse to participate and you are free to 
withdraw from this study at any time without penalty or loss of benefits to which you are 
otherwise entitled. As with medications typically prescribed following sinus surgery, you or your 
insurance will be responsible for the cost of ibuprofen. We will provide you with $20 
remuneration via gift card upon successful completion of your portion of this study.  
 
RESEARCH-RELATED INJURY 


Effect of Post-operative Ibuprofen after Surgery for Chronic Rhinosinusitis: 11/25/16 
 
4 of 4 
 
If at any time you would like to withdraw from this study, contact the University of Washington 
Otolaryngology Clinic at (206) 598-8545 during regular business hours or ask to have the ENT 
resident on-call paged through the University of Washington Medical Center operator at (206) 
598-3300 after hours right away.  He/she will notify the study team of your desire to withdraw. If 
at any time you feel that you have been harmed by participating in this study, contact Dr. Craig 
Miller at Craigmil@uw.edu. He will treat you or refer you for treatment. 
 
 
 
 
 
Printed name of study staff obtaining consent 
Signature 
Date 
 
Subject’s statement 
This study has been explained to me.  I volunteer to take part in this research.  I have had a 
chance to ask questions.  If I have questions later about the research, or if I have been harmed by 
participating in this study, I can contact one of the researchers listed on the first page of this 
consent form.  If I have questions about my rights as a research subject, I can call the Human 
Subjects Division at (206) 543-0098.  I give permission to the researchers to use my medical 
records as described in this consent form.  I will receive a copy of this consent form. 
 
 
Printed name of subject 
 
Signature of subject  
 
 
Date 
 
 
Copies to: 
Researcher 
 
 
Subject