Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01695967
Recruitment Status : Recruiting
First Posted : September 28, 2012
Last Update Posted : February 1, 2018
Information provided by (Responsible Party):
Cristina Baldassari M.D., Eastern Virginia Medical School

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Nasal Obstruction Procedure: turbinate cauterization Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial
Study Start Date : August 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Turbinate Cauterization
Turbinate Cauterization will be completed.
Procedure: turbinate cauterization
No Intervention: control
no turbinate cauterization

Primary Outcome Measures :
  1. # of participants with improved nasal obstruction score from baseline to 6 months [ Time Frame: 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01695967

Contact: Chrisina Baldassari, MD 757-668-6200

United States, Virginia
Children's Hospital of the King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Christina Baldasarri, MD    757-388-6200   
Contact: Laura Stone, RN    7573886238   
Principal Investigator: Christina Baldassari, MD         
Sponsors and Collaborators
Eastern Virginia Medical School
Principal Investigator: Christina Baldassari, MD Eastern Virginia Medical School

Responsible Party: Cristina Baldassari M.D., Assistant Professor, Pediatric Otolaryngology, Eastern Virginia Medical School Identifier: NCT01695967     History of Changes
Other Study ID Numbers: version 3 03Mar2012
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by Cristina Baldassari M.D., Eastern Virginia Medical School:
nasal obstruction

Additional relevant MeSH terms:
Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases