Coblation-Tonsillotomy vs Electrocautery-Tonsillectomy for the Treatment of Obstructive Sleep Apnea (OSA) in Children
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ClinicalTrials.gov Identifier: NCT00694772 |
Recruitment Status
: Unknown
Verified June 2008 by University of Calgary.
Recruitment status was: Recruiting
First Posted
: June 10, 2008
Last Update Posted
: June 10, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea | Procedure: Electrocautery-tonsillectomy Procedure: Coblation-tonsillotomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Coblation-Tonsillotomy Versus Electrocautery-Tonsillectomy for Treatment of Moderate and Severe Obstructive Sleep Apnea in Children: A Randomized, Prospective, Single-Blinded Study |
Study Start Date : | June 2008 |
Estimated Primary Completion Date : | June 2013 |
Estimated Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Electrocautery |
Procedure: Electrocautery-tonsillectomy
standard of care electrocautery tonsillectomy
|
Experimental: Coblation |
Procedure: Coblation-tonsillotomy
use of Arthrocare Coblation Technology to perform tonsillotomy
Other Name: alternative procedure name: subcapsular tonsillectomy
|
- 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) [ Time Frame: 6 months and 2 years post-op ]
- Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy [ Time Frame: 1 week post-op ]
- Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA [ Time Frame: 6-8 weeks post-op ]

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Ages Eligible for Study: | 2 Years to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00694772
Contact: Derek S Drummond, MD, MPH | (403) 955-2218 | dsdrummond@shaw.ca |
Canada, Alberta | |
Alberta Children's Hospital | Recruiting |
Calgary, Alberta, Canada, T3B 6A8 | |
Contact: Derek S Drummond, MD, MPH (403) 955-2218 dsdrummond@shaw.ca | |
Principal Investigator: Derek S Drummond, MD, MPH | |
Sub-Investigator: Warren K Yunker, MD, PhD | |
Sub-Investigator: Valerie G Kirk, MD | |
Sub-Investigator: David Lardner, MD |
Principal Investigator: | Derek S Drummond, MD, MPH | University of Calgary |
Responsible Party: | Derek Drummond, University of Calgary |
ClinicalTrials.gov Identifier: | NCT00694772 History of Changes |
Other Study ID Numbers: |
E-21417 |
First Posted: | June 10, 2008 Key Record Dates |
Last Update Posted: | June 10, 2008 |
Last Verified: | June 2008 |
Keywords provided by University of Calgary:
Obstructive sleep apnea OSA Apnea hypopnea index AHI |
Coblation Electrocautery Tonsillectomy Tonsillotomy |
Additional relevant MeSH terms:
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |