Back to resultsTurbinate Cauterization in Pediatric Patients With Nasal Obstruction
Primary Purpose
Sleep Apnea, Nasal Obstruction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
turbinate cauterization
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring nasal obstruction
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of the King's Daughters
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Turbinate Cauterization
control
Arm Description
Turbinate Cauterization will be completed.
no turbinate cauterization
Outcomes
Primary Outcome Measures
# 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01695967
First Posted
September 24, 2012
Last Updated
August 18, 2021
Sponsor
Eastern Virginia Medical School
1. Study Identification
Unique Protocol Identification Number
NCT01695967
Brief Title
Turbinate Cauterization in Pediatric Patients With Nasal Obstruction
Official Title
Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Virginia Medical School
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
To assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Nasal Obstruction
Keywords
nasal obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Turbinate Cauterization
Arm Type
Experimental
Arm Description
Turbinate Cauterization will be completed.
Arm Title
control
Arm Type
No Intervention
Arm Description
no turbinate cauterization
Intervention Type
Procedure
Intervention Name(s)
turbinate cauterization
Primary Outcome Measure Information:
Title
# of participants with improved nasal obstruction score from baseline to 6 months
Description
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.
Time Frame
baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Baldassari, MD
Organizational Affiliation
Eastern Virginia Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Turbinate Cauterization in Pediatric Patients With Nasal Obstruction
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