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Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02062996
Enrollment
0
Registered
2014-02-14
Start date
2014-06-30
Completion date
2014-07-31
Last updated
2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anesthesia, Nasal Surgical Procedures, Intranasal Drug Administration

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.

Interventions

Sponsors

Richard Cartabuke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Oxymetazoline plasma concentration5, 10, 20, 45, 90 & 150 mins. after dosing

Secondary

MeasureTime frameDescription
Heart rateEvery 2-5 mins. for a maximum of 240 mins.Assessing for bradycardia
Blood pressureEvery 2-5 mins. for a maximum of 240 mins.Assessing for hypertension.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026