Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption
Status:
Withdrawn
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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.