Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

NCT01695967 | Completed

• 1 other identifier: version 3 03Mar2012
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Nasal Obstruction

Keywords

nasal obstruction

Outcome Measures

Primary Outcomes (1)

• # 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.

  baseline and 6 months

Study Arms (2)

Turbinate Cauterization

EXPERIMENTAL

Turbinate Cauterization will be completed.

Procedure: turbinate cauterization

control

NO INTERVENTION

no turbinate cauterization

Interventions

turbinate cauterization PROCEDURE

Turbinate Cauterization

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Nasal Obstruction

Condition Hierarchy (Ancestors)

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

Study Officials

• Christina Baldassari, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatric Otolaryngology

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 28, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

US (1)