Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

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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Key information

Conditions

Sleep Apnea Airway Obstruction Apnea Dyssomnias Nasal Obstruction Nervous System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

turbinate cauterization

Procedure

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Registry information

Official study title

Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial

Important dates

Study start: 2012
Primary completion: 2020
Study completion: 2020
First posted: Sep 28, 2012
Registry last updated: Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed