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Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison

Not Applicable
Completed
Conditions
Chronic Sinusitis
Interventions
Registration Number
NCT00626366
Lead Sponsor
University of Nebraska
Brief Summary

The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used.

Detailed Description

The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. The study hypothesizes that nasal drops will reach the frontonasal region more often than nasal sprays.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
Inclusion Criteria
  • adult able to perform activities of daily living
Exclusion Criteria
  • signs or symptoms of acute or chronic paranasal sinus disease
  • history of sinus surgery
  • symptomatic deviated septum
  • active seasonal allergies
  • allergies to contrast
  • history of nasal polyposis
  • pregnant or breast feeding women
  • neck or back problems that would prevent a subject from kneeling on the floor and crouching over
  • currently taking metformin or amiodarone
  • students or stff under the direct supervision of the investigators
  • cognitive impairment
  • terminal illness

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Nasal sprayOmnipaque 240 Contrast SolutionThis arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.
Nasal dropSinus CT ScanThis arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.
Nasal spraySinus CT ScanThis arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.
Nasal dropOmnipaque 240 mg I/mLThis arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.
Primary Outcome Measures
NameTimeMethod
To Measure the Distribution of Nasal Sprays and Drops.2 months

CT scan scored for distribution contrast delivered by nasal spray or drops within subsets in the nasal cavity. The sinonasal cavity was divided into twenty-one subsites on each side of the nasal cavity. The interpreters scored for the presence (1) or absence (0) of contrast from the nasal spray or nasal drops within each subsite. Left and right sides were interpreted separately for a possible total score of 0-42 for each CT scan.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

ENT Specialist PC of Omaha

🇺🇸

Omaha, Nebraska, United States

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