Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

NCT ID: NCT02062996

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-07-31

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.

Conditions

Dental Anesthesia; Nasal Surgical Procedures; Intranasal Drug Administration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ENT - full strength

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

Group Type: EXPERIMENTAL

Oxymetazoline

Intervention Type: DRUG

ENT - 1/2 strength

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

Group Type: EXPERIMENTAL

Oxymetazoline

Intervention Type: DRUG

DENTAL - Full strength 1.0 mL

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

Group Type: EXPERIMENTAL

Oxymetazoline

Intervention Type: DRUG

DENTAL - Full strength 0.5 mL

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

Group Type: EXPERIMENTAL

Oxymetazoline

Intervention Type: DRUG

DENTAL - ½ strength 0.5 mL

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

Group Type: EXPERIMENTAL

Oxymetazoline

Intervention Type: DRUG

Interventions

Oxymetazoline

Intervention Type: DRUG

Other Intervention Names

Afrin

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Richard Cartabuke

OTHER

Sponsor Role: lead

Responsible Party

Richard Cartabuke

Co-Director Outpatient Anesthesia Services

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Richard Cartabuke, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

IRB14-00016

Identifier Type: -

Identifier Source: org_study_id