Coblation-Tonsillotomy vs Electrocautery-Tonsillectomy for the Treatment of Obstructive Sleep Apnea (OSA) in Children

Coblation-Tonsillotomy Versus Electrocautery-Tonsillectomy for Treatment of Moderate and Severe Obstructive Sleep Apnea in Children: A Randomized, Prospective, Single-Blinded Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694772

Enrollment

100

Registered

2008-06-10

Start date

2008-06-30

Completion date

2013-06-30

Last updated

2008-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea, OSA, Apnea hypopnea index, AHI, Coblation, Electrocautery, Tonsillectomy, Tonsillotomy

Brief summary

Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most frequently performed surgical procedures in North America. The two most prevalent indications for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep apnea (OSA). OSA is a common childhood condition that is characterized by upper airway obstruction, disturbed sleep and disrupted normal respiratory gas exchange. In the majority of children with OSA, overgrowth of the adenoid and tonsils is the primary underlying aetiology, making tissue removal via AT the standard of care. The purpose of this study is to evaluate the effectiveness of two different surgical techniques, electrocautery-tonsillectomy and coblation-tonsillotomy, in the treatment of obstructive sleep apnea (OSA) in children.

Interventions

PROCEDUREElectrocautery-tonsillectomy

standard of care electrocautery tonsillectomy

PROCEDURECoblation-tonsillotomy

use of Arthrocare Coblation Technology to perform tonsillotomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 8 Years

Healthy volunteers

Inclusion criteria

* Moderate or severe OSA on PSG (AHI ≥ 5.0) * Pronounced tonsillar hyperplasia on physical exam * No previous tonsil or adenoid surgery * No history of recurrent tonsillitis * Participants and their families must be willing to comply with follow-up * Parents/caregivers fluent in English

Exclusion criteria

* Severe co-morbidities, including, but not limited to, poorly controlled asthma, chromosomal abnormalities, and developmental delay

Design outcomes

Primary

Measure	Time frame
Compare coblation-tonsillotomy to electrocautery-tonsillectomy as a treatment of obstructive sleep apnea (OSA), as assessed by apnea-hypopnea index (AHI) measured on polysomnography (PSG)	6 months and 2 years post-op

Secondary

Measure	Time frame
Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy	1 week post-op
Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA	6-8 weeks post-op

Countries

Canada

Contacts

Primary ContactDerek S Drummond, MD, MPH

dsdrummond@shaw.ca(403) 955-2218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026