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Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy (jPK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00466544
Recruitment Status : Unknown
Verified March 2007 by Children's Hospital of Michigan.
Recruitment status was:  Not yet recruiting
First Posted : April 27, 2007
Last Update Posted : April 27, 2007
Information provided by:
Children's Hospital of Michigan

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

Condition or disease Intervention/treatment Phase
Obstructive Tonsillar Hypertrophy Tonsillitis Device: Plasmaknife Device: Monopolar Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Primary Outcome Measures :
  1. pain

Secondary Outcome Measures :
  1. return to normal activity
  2. return to normal diet
  3. medication dose taken

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00466544

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United States, Michigan
Detroit Children's Hospital Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: David Madgy    313-745-9048   
Contact: Mary Ross    (313) 745-9050   
Principal Investigator: David Madgy         
Sponsors and Collaborators
Children's Hospital of Michigan
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Principal Investigator: David Madgy Detroit Children's Hospital

Layout table for additonal information Identifier: NCT00466544     History of Changes
Other Study ID Numbers: 036706MP4F
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: March 2007
Keywords provided by Children's Hospital of Michigan:
Chronic tonsillitis
Recurrent tonsillitis
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases