Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Adenoidectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453841
• Other study ID #: IRB14-00723
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: April 20, 2017

Study information

• Verified date: September 2018
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 20, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoidectomy
• Functional Endoscopic Sinus Surgery (FESS)
• Turbinate Surgery

Intervention

Drug:
• Oxymetazoline

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Richard Cartabuke

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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