Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Richard Cartabuke

Status and phase: Withdrawn; Phase 2

Conditions: Nasal Surgical Procedures; Dental Anesthesia; Intranasal Drug Administration

Treatments: Drug: Oxymetazoline

Study type: Interventional

Funder types: Other

Identifiers

NCT02062996

IRB14-00016

Details and patient eligibility

About

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.

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 5 patient groups

ENT - full strength

Experimental group

Description:

Full strength oxymetazoline pledgets packed in the nose (total volume 20 ml).

Treatment:

Drug: Oxymetazoline

ENT - 1/2 strength

Experimental group

Description:

½ strength oxymetazoline pledgets packed in the nose (total volume 20 ml).

Treatment:

Drug: Oxymetazoline

DENTAL - Full strength 1.0 mL

Experimental group

Description:

Full strength oxymetazoline 1.0 mL to each naris (total =1000 mcg).

Treatment:

Drug: Oxymetazoline

DENTAL - Full strength 0.5 mL

Experimental group

Description:

Full strength oxymetazoline 0.5 mL to each naris (total = 500 mcg).

Treatment:

Drug: Oxymetazoline

DENTAL - ½ strength 0.5 mL

Experimental group

Description:

½ strength oxymetazoline 0.5 mL to each naris (total = 250 mcg).

Treatment:

Drug: Oxymetazoline