Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Study Overview
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Brief Summary
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This proposed study will assess the hemodynamic effects and measure the systemic absorption of topically applied oxymetazoline in patients undergoing functional endoscopic sinus surgery, turbinate surgery, or adenoidectomy. These patients will be receiving oxymetazoline as standard of care during the surgery.

Official Title
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Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery or Adenoidectomy

Conditions
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Adenoidectomy, Functional Endoscopic Sinus Surgery (FESS), Turbinate Surgery

Intervention / Treatment
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* Drug: Oxymetazoline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that are scheduled for: Functional endoscopic sinus surgery Turbinate reduction (with or without tonsillectomy and/or adenoidectomy) Adenoidectomy Exclusion Criteria: Been treated with oral decongestants or antihistamines within 24 hours of surgery Are taking anticoagulants Have a history of nasal trauma Have a history of epistaxis Have a history of hypertension or cardiac disease Allergy to oxymetazoline

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FESS<br>Patients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery. | Drug: Oxymetazoline<br> <br> * Other names: Afrin;|
| Active Comparator: Turbinates<br>Patients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery. | Drug: Oxymetazoline<br> <br> * Other names: Afrin;|
| Active Comparator: Adenoidectomy<br>Patients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery. | Drug: Oxymetazoline<br> <br> * Other names: Afrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Following Oxymetazoline Administration | Blood pressure was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first. | 5 - 150 mins. after administration | 
| Heart Rate Following Oxymetazoline Administration. | Heart rate was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first. | 5 - 150 mins. after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Hemostasis | A six point scale (very easy, easy, usual, some effort, difficult, extremely difficult) completed by the surgeon at the end of surgery. | intraoperative | 
| Amount of Bleeding | A four point scale (none, minimal, moderate/diffuse ooze, severe/brisk) completed by the surgeon after removal of the oxymetazoline soaked pledgets. | intraoperative |