Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy - Full Text View

Sponsored by:	Children's Hospital of Michigan
Information provided by:	Children's Hospital of Michigan
ClinicalTrials.gov Identifier:	NCT00466544

Purpose

Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.

Condition	Intervention	Phase
Obstructive Tonsillar Hypertrophy Tonsillitis	Device: Plasmaknife Device: Monopolar	Phase IV

MedlinePlus related topics: Tonsils and Adenoids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Further study details as provided by Children's Hospital of Michigan:

Primary Outcome Measures:

pain

Secondary Outcome Measures:

return to normal activity
return to normal diet
medication dose taken

Estimated Enrollment:	100
Study Start Date:	May 2007

Detailed Description:

This is a prospective, randomized controlled study to compare the efficacy of the Gyrus ACMI PlasmaKnife™ electrosurgical device used with the Gyrus ACMI Workstation versus monopolar electrosurgical device (i.e. Bovie®) for tonsillectomy.

The primary outcome will study the potential for reduced post-operative pain when the PlasmaKnife is used for tonsillectomy compared to a monopolar device. Secondary outcomes such as return to normal diet and activity as well as a range of complications including primary and secondary bleeding will be included in the study.

The study will involve approximately 100 patients at Children’s Hospital of Michigan that meet the criteria for tonsillectomy (with or without adenoidectomy) for infected tonsils or airway obstruction.

The study will be documented through the use of Case Report Forms.

Eligibility

Ages Eligible for Study:	4 Years to 16 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patient should be between the ages of 4 and 16 years old inclusive.
Patient should meet criteria for tonsillectomy.
Patient’s guardian able and willing to complete patient diary and keep to the follow-up visit.
Guardian able to understand English (written and oral).

Exclusion Criteria:

Patient that has active medical implant(s) such as pacemaker, cochlear implant, etc.
Patient has abnormal blood coagulation, history of easy bruising, bleeding disorders or uses anti-coagulants.
Morbidly obese children (calculated BMI over 39)
Patient that has history of malignancy or acute peritonsillar abscess
Patient has Sickle Cell disease or is immunocompromised.
Patient is pregnant or lactating.
Active infection with fever greater than 101.5 degrees F.
History of heart disease, diabetes or hypertension (with systolic blood pressure > 160 mmHg).
Craniofacial anomaly.
Biopsy of tonsil needed to rule out neoplasm.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466544

Locations

United States, Michigan
Detroit Children's Hospital
Detroit, Michigan, United States, 48201

Sponsors and Collaborators

Children's Hospital of Michigan

Investigators

Principal Investigator:

David Madgy

Detroit Children's Hospital

More Information

Study ID Numbers:	036706MP4F
Study First Received:	April 26, 2007
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00466544
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Michigan:

Chronic tonsillitis
Recurrent tonsillitis

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypertrophy
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Tonsillitis
Stomatognathic Diseases
Pharyngeal Diseases
Recurrence

ClinicalTrials.gov processed this record on January 15, 2009