Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy (jPK)
Recruitment status was Not yet recruiting
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.
Obstructive Tonsillar Hypertrophy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
- return to normal activity
- return to normal diet
- medication dose taken
|Study Start Date:||May 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466544
|United States, Michigan|
|Detroit Children's Hospital||Not yet recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: David Madgy 313-745-9048 firstname.lastname@example.org|
|Contact: Mary Ross (313) 745-9050 email@example.com|
|Principal Investigator: David Madgy|
|Principal Investigator:||David Madgy||Detroit Children's Hospital|