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Completed

NCT Number: NCT02453841

Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

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.

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Key information

Conditions

Adenoidectomy Functional Endoscopic Sinus Surgery (FESS) Turbinate Surgery

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxymetazoline

Drug

Other names: Afrin

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Richard Cartabuke

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 27, 2015
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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