A Phase 2 interventional study of Oxymetazoline in Dental Anesthesia, Nasal Surgical Procedures and Intranasal Drug Administration, sponsored by Richard Cartabuke. Withdrawn at 1 site in United States. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2015-08-07.
Sponsored by Richard Cartabuke · Phase 2, Interventional, and Treatment
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.
Richard Cartabuke is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Full strength oxymetazoline pledgets packed in the nose (total volume 20 ml).
Drug: Oxymetazoline
½ strength oxymetazoline pledgets packed in the nose (total volume 20 ml).
Drug: Oxymetazoline
Full strength oxymetazoline 1.0 mL to each naris (total =1000 mcg).
Drug: Oxymetazoline
Full strength oxymetazoline 0.5 mL to each naris (total = 500 mcg).
Drug: Oxymetazoline
½ strength oxymetazoline 0.5 mL to each naris (total = 250 mcg).
Drug: Oxymetazoline
Also known as: Afrin
Oxymetazoline plasma concentration
Time frame: 5, 10, 20, 45, 90 & 150 mins. after dosing
Heart rate
Assessing for bradycardia
Time frame: Every 2-5 mins. for a maximum of 240 mins.
Blood pressure
Assessing for hypertension.
Time frame: Every 2-5 mins. for a maximum of 240 mins.
This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Richard Cartabuke