Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Eastern Virginia Medical School
Sponsor:
Information provided by (Responsible Party):
Cristina Baldassari M.D., Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01695967
First received: September 24, 2012
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Sleep Apnea
Nasal Obstruction
Procedure: turbinate cauterization

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • # 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.


Estimated Enrollment: 110
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Turbinate Cauterization
Turbinate Cauterization will be completed.
Procedure: turbinate cauterization
No Intervention: control
no turbinate cauterization

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695967

Contacts
Contact: Chrisina Baldassari, MD 757-668-6200 cristina.baldassari@chkd.org

Locations
United States, Virginia
Children's Hospital of the King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Christina Baldasarri, MD    757-388-6200    christina.baldassari@chkd.org   
Contact: Laura Stone, RN    7573886238    stonelj@evms.edu   
Principal Investigator: Christina Baldassari, MD         
Sponsors and Collaborators
Eastern Virginia Medical School
Investigators
Principal Investigator: Christina Baldassari, MD Eastern Virginia Medical School
  More Information

No publications provided

Responsible Party: Cristina Baldassari M.D., Assistant Professor, Pediatric Otolaryngology, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01695967     History of Changes
Other Study ID Numbers: version 3 03Mar2012
Study First Received: September 24, 2012
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:
nasal obstruction

Additional relevant MeSH terms:
Nasal Obstruction
Sleep Apnea Syndromes
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014