Completed

Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial

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What is being tested

turbinate cauterization

Procedure
Who is being recruted

Airway Obstruction+10

+ Apnea

+ Nervous System Diseases

From 3 to 16 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorEastern Virginia Medical School
Last updated: August 19, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01695967
Principal SponsorEastern Virginia Medical School
Last updated: August 19, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

110 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Airway ObstructionApneaNervous System DiseasesNose DiseasesOtorhinolaryngologic DiseasesRespiration DisordersRespiratory InsufficiencyRespiratory Tract DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasSleep Apnea SyndromesNasal Obstruction

Criteria

5 inclusion criteria required to participate
ages 3-16
failed medical treatment with either oral anti-histamine or nasal steroid spray
history of daytime nasal obstruction and or mouth breathing
obstructive sleep apnea warranting adenotonsillectomy
Show More Criteria
7 exclusion criteria prevent from participating
3 or > 16
bleeding disorders
congenital head and neck malformations, genetic syndromes, craniofacial anomalies
current therapy with coumadin or Pradaxa
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Turbinate Cauterization will be completed.

Group II

No Intervention
no turbinate cauterization

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Children's Hospital of the King's Daughters

Norfolk, United StatesOpen Children's Hospital of the King's Daughters in Google Maps
CompletedOne Study Center