Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

• Status: Withdrawn
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic agent in over-the-counter decongestant sprays. It is used extensively at Nationwide Children's Hospital for surgical procedures to produce vasoconstriction and reduce bleeding. Although there is generally limited vascular absorption, when administered in larger doses, uptake of oxymetazoline can lead to significant systemic hemodynamic effects. The NCH anesthesia department recently reported a case of oxymetazoline induced postoperative hypertension in a three-year-old child following inferior turbinate reduction and adenoidectomy. Current practice at NCH is to soak pledgets with full strength oxymetazoline and insert a varying number of pledgets during surgical procedures or instill oxymetazoline drops into the nose prior to nasotracheal intubation. There is no pediatric data regarding the method of administration and the absorption of oxymetazoline or the dose-response relationship of oxymetazoline serum levels on blood pressure and heart rate. These studies would be the first to determine safe and appropriate doses of oxymetazoline in the pediatric population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Richard Cartabuke
• Treatments: Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

• Patients ages 2 through 12 yrs.

• Scheduled for: operative dentistry, functional endoscopic sinus surgery, or turbinate reduction (with or without tonsillectomy and/or adenoidectomy).

Exclusion Criteria:

• Treatment with oral decongestants or antihistamines within 24 hours of surgery.

• Taking anticoagulants.

• History of nasal trauma.

• History of epistaxis (nose bleeds).

• History of hypertension or cardiac disease.

• Allergy to oxymetazoline.