Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

September 17, 2018 updated by: Richard Cartabuke

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FESS
Patients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery.
Drug: Oxymetazoline
Other Names:
  • Afrin
Active Comparator: Turbinates
Patients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery.
Drug: Oxymetazoline
Other Names:
  • Afrin
Active Comparator: Adenoidectomy
Patients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery.
Drug: Oxymetazoline
Other Names:
  • Afrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Following Oxymetazoline Administration
Time Frame: 5 - 150 mins. after 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.
Time Frame: 5 - 150 mins. after 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
Time Frame: intraoperative
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
Time Frame: intraoperative
A four point scale (none, minimal, moderate/diffuse ooze, severe/brisk) completed by the surgeon after removal of the oxymetazoline soaked pledgets.
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Richard Cartabuke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

April 20, 2017

Study Completion (Actual)

April 20, 2017

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB14-00723

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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