Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

Eastern Virginia Medical School110 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

110

Conditions

Sleep Apnea Nasal Obstruction

Interventions

turbinate cauterizationPROCEDURE

Eligibility

Sex: ALLMin age: 3 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States

Outcomes

Primary Outcomes

# of participants with improved nasal obstruction score from baseline to 6 months

Baseline assessment compared to 6 mo post surgery. The SN-5 Nasal Obstruction and Sinonasal Quality of Life instrument tools will be used to record nasal obstruction symptom scores.

Time frame: baseline and 6 months

Data from ClinicalTrials.gov

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