Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Phase 2

Withdrawn

• Conditions: Dental Anesthesia; Nasal Surgical Procedures; Intranasal Drug Administration
• Interventions: Drug: Oxymetazoline

• Registration Number: NCT02062996
• Lead Sponsor: Richard Cartabuke

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Study Start: 2014-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-06
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ENT - full strength	Oxymetazoline	Full strength oxymetazoline pledgets packed in the nose (total volume 20 ml).
DENTAL - Full strength 0.5 mL	Oxymetazoline	Full strength oxymetazoline 0.5 mL to each naris (total = 500 mcg).
ENT - 1/2 strength	Oxymetazoline	½ strength oxymetazoline pledgets packed in the nose (total volume 20 ml).
DENTAL - Full strength 1.0 mL	Oxymetazoline	Full strength oxymetazoline 1.0 mL to each naris (total =1000 mcg).
DENTAL - ½ strength 0.5 mL	Oxymetazoline	½ strength oxymetazoline 0.5 mL to each naris (total = 250 mcg).

Primary Outcome Measures

Name	Time	Method
Oxymetazoline plasma concentration	5, 10, 20, 45, 90 & 150 mins. after dosing

Secondary Outcome Measures

Name	Time	Method
Heart rate	Every 2-5 mins. for a maximum of 240 mins.	Assessing for bradycardia
Blood pressure	Every 2-5 mins. for a maximum of 240 mins.	Assessing for hypertension.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States