Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Richard Cartabuke30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adenoidectomy Functional Endoscopic Sinus Surgery (FESS)Turbinate Surgery

Interventions

OxymetazolineDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients that are scheduled for: 1. Functional endoscopic sinus surgery 2. Turbinate reduction (with or without tonsillectomy and/or adenoidectomy) 3. 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

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 5 - 150 mins. after administration

Secondary Outcomes

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.

Time frame: 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.

Time frame: intraoperative

Data from ClinicalTrials.gov

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