Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Dental Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02062996
• Other study ID #: IRB14-00016
• Status: Withdrawn
• Phase: Phase 2
• First received: February 12, 2014
• Last updated: August 6, 2015
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Anesthesia
• Intranasal Drug Administration
• Nasal Surgical Procedures

Intervention

Drug:
• Oxymetazoline

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Richard Cartabuke

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxymetazoline plasma concentration		5, 10, 20, 45, 90 & 150 mins. after dosing	No
Secondary	Heart rate	Assessing for bradycardia	Every 2-5 mins. for a maximum of 240 mins.	Yes
Secondary	Blood pressure	Assessing for hypertension.	Every 2-5 mins. for a maximum of 240 mins.	Yes