Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
Summary
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.
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.
Study Design
Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Obstructive Tonsillar Hypertrophy
Intervention
Plasmaknife, Monopolar
Location
Detroit Children's Hospital
Detroit
Michigan
United States
48201
Status
Not yet recruiting
Source
Children's Hospital of Michigan
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00466544
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-24T14:21:39-0400
Clinical Trials
The aim of this study is to compare the efficacy and safety of drug therapy, tonsillar adenoidectomy only, orthodontic treatment only and tonsillar adenoidectomy plus orthodontic treatment...
Comparison of Different Energy Sources During TUR-P
With this study, it is aimed to compare the operative results and complication rates in transurethral resection of the prostate (TUR-P) performed by resectoscopes with two different bipola...
Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing
Introduction: There is currently no long-term study, which compares the outcomes of partial tonsillectomy to conventional tonsillectomy. We hypothesize that there will be little signific...
The ultimate goal of this work is to establish a method for control bleeding after tonsillectomy in awake children. Treatment of post-tonsillectomy bleeding in children typically requires ...
Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children
Objective: Postoperative pain is the main complaint in children undergoing tonsillectomy. An inexpensive method and with few evidence in the literature on effectiveness in reducing pain is...
PubMed Articles
Differentiating Tonsil Cancer from Benign Tonsillar Hypertrophy.
Adenotonsillectomy (ATE) is the primary surgical method for treating obstructive sleep apnea (OSA) in children. However, children with severe OSA have an increased risk for residual OSA after ATE. Pre...
Cerebellar tonsillar cysts associated with Chiari malformation in adults: A short series.
Authors analyzed surgical patients with Chiari malformation (CM) associated with cerebellar tonsillar cyst. This association is quite rarely encountered in the literature.
Pediatric obstructive sleep apnea-hypopnea syndrome is caused by multiple factors. The present study aimed to investigate the potential risks of pediatric obstructive sleep apnea hypopnea syndrome (OS...
To determine fundamental characteristics of pathological cardiac hypertrophy, protein expression profiles in two widely accepted models of cardiac hypertrophy (swimming-trained mouse for physiological...
Medical and Biotech [MESH] Definitions
Pulmonary Heart Disease
Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.
Sleep Apnea, Central
A condition associated with multiple episodes of sleep apnea which are distinguished from obstructive sleep apnea (SLEEP APNEA, OBSTRUCTIVE) by the complete cessation of efforts to breathe. This disorder is associated with dysfunction of central nervous system centers that regulate respiration. This condition may be idiopathic (primary) or associated with lower brain stem lesions; chronic obstructive pulmonary disease (LUNG DISEASES, OBSTRUCTIVE); HEART FAILURE, CONGESTIVE; medication effect; and other conditions. Sleep maintenance is impaired, resulting in daytime hypersomnolence. Primary central sleep apnea is frequently associated with obstructive sleep apnea. When both forms are present the condition is referred to as mixed sleep apnea (see SLEEP APNEA SYNDROMES). (Adams et al., Principles of Neurology, 6th ed, p395; Neurol Clin 1996;14(3):611-28)
Tonsillar Neoplasms
Tumors or cancer of the PALATINE TONSIL.
Sleep Apnea Syndromes
Disorders characterized by multiple cessations of respirations during sleep that induce partial arousals and interfere with the maintenance of sleep. Sleep apnea syndromes are divided into central (see SLEEP APNEA, CENTRAL), obstructive (see SLEEP APNEA, OBSTRUCTIVE), and mixed central-obstructive types.
Cardiomyopathy, Hypertrophic
A form of CARDIAC MUSCLE disease, characterized by left and/or right ventricular hypertrophy (HYPERTROPHY, LEFT VENTRICULAR; HYPERTROPHY, RIGHT VENTRICULAR), frequent asymmetrical involvement of the HEART SEPTUM, and normal or reduced left ventricular volume. Risk factors include HYPERTENSION; AORTIC STENOSIS; and gene MUTATION; (FAMILIAL HYPERTROPHIC CARDIOMYOPATHY).
