Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

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.

Full Title of Study: “Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2020

Detailed Description

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

Interventions

  • Procedure: turbinate cauterization

Arms, Groups and Cohorts

  • Experimental: Turbinate Cauterization
    • Turbinate Cauterization will be completed.
  • No Intervention: control
    • no turbinate cauterization

Clinical Trial Outcome Measures

Primary Measures

  • # 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eastern Virginia Medical School
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cristina Baldassari M.D., Assistant Professor, Pediatric Otolaryngology – Eastern Virginia Medical School
  • Overall Official(s)
    • Christina Baldassari, MD, Principal Investigator, Eastern Virginia Medical School

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