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Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Sponsor
Richard Cartabuke (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02062996
Collaborator
(none)
0
Enrollment
1
Location
5
Arms
30
Duration (Days)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Oxymetazoline plasma concentration [5, 10, 20, 45, 90 & 150 mins. after dosing]

    Secondary Outcome Measures

    1. Heart rate [Every 2-5 mins. for a maximum of 240 mins.]

      Assessing for bradycardia

    2. Blood pressure [Every 2-5 mins. for a maximum of 240 mins.]

      Assessing for hypertension.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nationwide Children's Hospital Columbus Ohio United States 43205

    Sponsors and Collaborators

    • Richard Cartabuke

    Investigators

    • Principal Investigator: Richard Cartabuke, MD, Nationwide Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Richard Cartabuke, Co-Director Outpatient Anesthesia Services, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02062996
    Other Study ID Numbers:
    • IRB14-00016
    First Posted:
    Feb 14, 2014
    Last Update Posted:
    Aug 7, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Phenylephrine
    Oxymetazoline

    Study Results

    No Results Posted as of Aug 7, 2015