NCT00466544

Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Children's Hospital of Michigan · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: —

Summary

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

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.

Conditions

• Obstructive Tonsillar Hypertrophy
• Tonsillitis

Interventions

Type	Name	Description
DEVICE	Plasmaknife
DEVICE	Monopolar

Timeline

• Start date: 2007-05-01
• First posted: 2007-04-27
• Last updated: 2007-04-27

Locations

1 site across 1 country: United States