Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Richard Cartabuke

Status: Completed

Conditions: Functional Endoscopic Sinus Surgery (FESS); Adenoidectomy; Turbinate Surgery

Treatments: Drug: Oxymetazoline

Study type: Interventional

Funder types: Other

Identifiers

NCT02453841

IRB14-00723

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

FESS

Active Comparator group

Description:

Patients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery.

Treatment:

Drug: Oxymetazoline

Turbinates

Active Comparator group

Description:

Patients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery.

Treatment:

Drug: Oxymetazoline

Adenoidectomy

Active Comparator group

Description:

Patients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery.

Treatment:

Drug: Oxymetazoline