Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

August 6, 2015 updated by: Richard Cartabuke

The Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery and From the Nasal Mucosa During Operative Dentistry

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENT - full strength
Full strength oxymetazoline pledgets packed in the nose (total volume 20 ml).
Drug: Oxymetazoline
Other Names:
  • Afrin
Experimental: ENT - 1/2 strength
½ strength oxymetazoline pledgets packed in the nose (total volume 20 ml).
Drug: Oxymetazoline
Other Names:
  • Afrin
Experimental: DENTAL - Full strength 1.0 mL
Full strength oxymetazoline 1.0 mL to each naris (total =1000 mcg).
Drug: Oxymetazoline
Other Names:
  • Afrin
Experimental: DENTAL - Full strength 0.5 mL
Full strength oxymetazoline 0.5 mL to each naris (total = 500 mcg).
Drug: Oxymetazoline
Other Names:
  • Afrin
Experimental: DENTAL - ½ strength 0.5 mL
½ strength oxymetazoline 0.5 mL to each naris (total = 250 mcg).
Drug: Oxymetazoline
Other Names:
  • Afrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oxymetazoline plasma concentration
Time Frame: 5, 10, 20, 45, 90 & 150 mins. after dosing
5, 10, 20, 45, 90 & 150 mins. after dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: Every 2-5 mins. for a maximum of 240 mins.
Assessing for bradycardia
Every 2-5 mins. for a maximum of 240 mins.
Blood pressure
Time Frame: Every 2-5 mins. for a maximum of 240 mins.
Assessing for hypertension.
Every 2-5 mins. for a maximum of 240 mins.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Richard Cartabuke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB14-00016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Anesthesia

Clinical Trials on Oxymetazoline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe