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Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT03055507
Recruitment Status : Unknown
Verified October 2017 by Craig Miller, University of Washington.
Recruitment status was:  Recruiting
First Posted : February 16, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Craig Miller, University of Washington

Tracking Information
First Submitted Date  ICMJE February 10, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date October 26, 2017
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis
Official Title  ICMJE Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis: A Prospective, Pilot, Cohort Study
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Rhinosinusitis (Diagnosis)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Acetaminophen 650 mg
    • Drug: OxyCODONE 5 Mg Oral Tablet
  • 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.
    Interventions:
    • Drug: Ibuprofen 400 mg
    • Drug: Acetaminophen 650 mg
    • Drug: OxyCODONE 5 Mg Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 13, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2018
Estimated Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055507
Other Study ID Numbers  ICMJE STUDY00000798
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share IPD
Responsible Party Craig Miller, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Craig Miller, MD University of Washington
PRS Account University of Washington
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP