Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis

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 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
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.

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

- Current use of anti-coagulant or anti-platelet medication (during and immediately
after ESS)

- History of chronic pain, fibromyalgia, or opioid addiction

- 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.