Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea; Nasal Obstruction
• Intervention / Treatment: Procedure: turbinate cauterization

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Children's Hospital of The King's Daughters

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Turbinate Cauterization; Turbinate Cauterization will be completed.	Procedure: turbinate cauterization
No Intervention: control; no turbinate cauterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
# 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

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School
• Investigators: Principal Investigator: Christina Baldassari, MD, Eastern Virginia Medical School

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: nasal obstruction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: version 3 03Mar2012