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Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Craig Miller, University of Washington
ClinicalTrials.gov Identifier:
NCT03055507
First received: February 10, 2017
Last updated: May 2, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention Phase
Chronic Rhinosinusitis (Diagnosis)
Drug: Ibuprofen 400 mg
Drug: Acetaminophen 650 mg
Drug: OxyCODONE 5 Mg Oral Tablet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis: A Prospective, Pilot, Cohort Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Pain visual analogue scale [ Time Frame: Post-operative day 1 ]
    10-cm visual analogue scale used to indicate level of post-operative pain

  • Pain visual analogue scale [ Time Frame: Post-operative day 3 ]
    10-cm visual analogue scale used to indicate level of post-operative pain

  • Pain visual analogue scale [ Time Frame: Post-operative day 7 ]
    10-cm visual analogue scale used to indicate level of post-operative pain


Secondary Outcome Measures:
  • Number of opioid pills [ Time Frame: Post-operative days 1-7 ]
    Number of opioid pills taken daily following surgery

  • Bleeding VAS [ Time Frame: Post-operative days 1, 3, and 7 ]
    10-cm visual analogue scale used to indicate amount of nasal bleeding post-operatively

  • 0-4 bleeding scale [ Time Frame: Post-operative days 1, 3, and 7 ]
    Previously used 0-4 scale to indicate amount of nasal bleeding

  • Number of mustache gauze changes [ Time Frame: Post-operative days 1, 3, and 7 ]
    Number of daily changes to moustache dressing in the post-operative period


Estimated Enrollment: 60
Actual Study Start Date: April 1, 2017
Estimated Study Completion Date: September 30, 2017
Estimated Primary Completion Date: August 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
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 pain.
Drug: Acetaminophen 650 mg
Standard analgesic provided post-operatively to patients undergoing sinus surgery
Other Names:
  • Tylenol
  • Paracetamol
Drug: OxyCODONE 5 Mg Oral Tablet
Standard PRN medication offered post-operatively for breakthrough pain
Experimental: Ibuprofen
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.
Drug: Ibuprofen 400 mg
Addition of ibuprofen to standard pain regimen.
Other Name: Motrin
Drug: Acetaminophen 650 mg
Standard analgesic provided post-operatively to patients undergoing sinus surgery
Other Names:
  • Tylenol
  • Paracetamol
Drug: OxyCODONE 5 Mg Oral Tablet
Standard PRN medication offered post-operatively for breakthrough pain

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 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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03055507

Contacts
Contact: Craig Miller, MD 206-314-8781 craigmil@uw.edu
Contact: Greg E Davis, MD, MPH GEDavis@uw.edu

Locations
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Craig Miller, M.D.    206-598-1000    craigmil@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Craig Miller, MD University of Washington
  More Information

Responsible Party: Craig Miller, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT03055507     History of Changes
Other Study ID Numbers: STUDY00000798
Study First Received: February 10, 2017
Last Updated: May 2, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Acetaminophen
Ibuprofen
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017