Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

NCT02062996 | Withdrawn Phase 2

• 1 other identifier: IRB14-00016
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Oxymetazoline plasma concentration

  5, 10, 20, 45, 90 & 150 mins. after dosing

Secondary Outcomes (2)

• Heart rate

  Every 2-5 mins. for a maximum of 240 mins.

• Blood pressure

  Every 2-5 mins. for a maximum of 240 mins.

Study Arms (5)

ENT - full strength

EXPERIMENTAL

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

Drug: Oxymetazoline

ENT - 1/2 strength

EXPERIMENTAL

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

Drug: Oxymetazoline

DENTAL - Full strength 1.0 mL

EXPERIMENTAL

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

Drug: Oxymetazoline

DENTAL - Full strength 0.5 mL

EXPERIMENTAL

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

Drug: Oxymetazoline

DENTAL - ½ strength 0.5 mL

EXPERIMENTAL

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

Drug: Oxymetazoline

Interventions

Oxymetazoline DRUG

Also known as: Afrin

DENTAL - Full strength 0.5 mL; DENTAL - Full strength 1.0 mL; DENTAL - ½ strength 0.5 mL; ENT - 1/2 strength; ENT - full strength

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients ages 2 through 12 yrs.
• Scheduled for: operative dentistry, functional endoscopic sinus surgery, or turbinate reduction (with or without tonsillectomy and/or adenoidectomy).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Richard Cartabuke: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Oxymetazoline

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Richard Cartabuke, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Director Outpatient Anesthesia Services

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 14, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

US (1)