Turbinate Cauterization in Pediatric Patients With Nasal Obstruction
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial|
- # of participants with improved nasal obstruction score from baseline to 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Turbinate Cauterization
Turbinate Cauterization will be completed.
|Procedure: turbinate cauterization|
No Intervention: control
no turbinate cauterization
To assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695967
|Contact: Chrisina Baldassari, MDfirstname.lastname@example.org|
|United States, Virginia|
|Children's Hospital of the King's Daughters||Recruiting|
|Norfolk, Virginia, United States, 23507|
|Contact: Christina Baldasarri, MD 757-388-6200 email@example.com|
|Contact: Laura Stone, RN 7573886238 firstname.lastname@example.org|
|Principal Investigator: Christina Baldassari, MD|
|Principal Investigator:||Christina Baldassari, MD||Eastern Virginia Medical School|