Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

Not Applicable

Completed

• Conditions: Nasal Obstruction; Sleep Apnea
• Interventions: Procedure: turbinate cauterization

• Registration Number: NCT01695967
• Lead Sponsor: Eastern Virginia Medical School

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-09-28
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Turbinate Cauterization	turbinate cauterization	Turbinate Cauterization will be completed.

Primary Outcome Measures

Name	Time	Method
# of participants with improved nasal obstruction score from baseline to 6 months	baseline and 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.

Trial Locations

Locations (1)

Children's Hospital of the King's Daughters; 🇺🇸 Norfolk, Virginia, United States