Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

NCT ID: NCT02453841

Last Updated: 2018-09-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-04-20

Brief Summary

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This proposed study will assess the hemodynamic effects and measure the systemic absorption of topically applied oxymetazoline in patients undergoing functional endoscopic sinus surgery, turbinate surgery, or adenoidectomy. These patients will be receiving oxymetazoline as standard of care during the surgery.

Detailed Description

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Conditions

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Adenoidectomy Functional Endoscopic Sinus Surgery (FESS) Turbinate Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FESS

Patients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery.

Group Type ACTIVE_COMPARATOR

Oxymetazoline

Intervention Type DRUG

Turbinates

Patients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery.

Group Type ACTIVE_COMPARATOR

Oxymetazoline

Intervention Type DRUG

Adenoidectomy

Patients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery.

Group Type ACTIVE_COMPARATOR

Oxymetazoline

Intervention Type DRUG

Interventions

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Oxymetazoline

Intervention Type DRUG

Other Intervention Names

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Afrin

Eligibility Criteria

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Inclusion Criteria

* Patients that are scheduled for:

1. Functional endoscopic sinus surgery
2. Turbinate reduction (with or without tonsillectomy and/or adenoidectomy)
3. Adenoidectomy

Exclusion Criteria

* Been treated with oral decongestants or antihistamines within 24 hours of surgery
* Are taking anticoagulants
* Have a history of nasal trauma
* Have a history of epistaxis
* Have a history of hypertension or cardiac disease
* Allergy to oxymetazoline
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Richard Cartabuke

OTHER

Sponsor Role lead

Responsible Party

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Richard Cartabuke

Co-Director of Outpatient Anesthesia Services

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Richard Cartabuke, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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IRB14-00723

Identifier Type: -

Identifier Source: org_study_id

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