Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2020-12-31

Brief Summary

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patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and tonsillectomy. It will compare the amount of nasal congestion for each group with the idea that it will be less if treated with turbinate cauterization. Assessments from baseline to 6 months post procedure will be compared between the two groups.

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Detailed Description

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To assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.

Conditions

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Sleep Apnea Nasal Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Turbinate Cauterization

Turbinate Cauterization will be completed.

Group Type EXPERIMENTAL

turbinate cauterization

Intervention Type PROCEDURE

control

no turbinate cauterization

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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turbinate cauterization

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ages 3-16
* obstructive sleep apnea warranting adenotonsillectomy
* history of daytime nasal obstruction and or mouth breathing
* failed medical treatment with either oral anti-histamine or nasal steroid spray.
* turbinate hypertrophy on Physical Exam defined by \>50% obstruction

Exclusion Criteria

* \<3 or \>16
* unwillingness to comply with study procedures
* congenital head and neck malformations, genetic syndromes, craniofacial anomalies
* no evidence of turbinate hypertrophy or symptoms of nasal obstruction
* pregnancy or breastfeeding
* bleeding disorders
* current therapy with coumadin or Pradaxa

Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No