Nasal Obstruction, Sleep Apnea
Conditions
Keywords
nasal obstruction
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.
Interventions
PROCEDUREturbinate cauterization
Sponsors
Eastern Virginia Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| # of participants with improved nasal obstruction score from baseline to 6 months | 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. |
Countries
United States
Outcome results
None listed