Tonsillitis Clinical Trial
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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