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Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

Eastern Virginia Medical School (EVMS) logo

Eastern Virginia Medical School (EVMS)

Status

Completed

Conditions

Nasal Obstruction
Sleep Apnea

Treatments

Procedure: turbinate cauterization

Study type

Interventional

Funder types

Other

Identifiers

NCT01695967
version 3 03Mar2012

Details and patient eligibility

About

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.

Full description

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

Enrollment

110 estimated patients

Sex

All

Ages

3 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

110 participants in 2 patient groups

Turbinate Cauterization
Experimental group
Description:
Turbinate Cauterization will be completed.
Treatment:
Procedure: turbinate cauterization
control
No Intervention group
Description:
no turbinate cauterization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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