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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Children's Hospital of Michigan.
Recruitment status was:  Not yet recruiting
Information provided by:
Children's Hospital of Michigan Identifier:
First received: April 26, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.

Condition Intervention Phase
Obstructive Tonsillar Hypertrophy Tonsillitis Device: Plasmaknife Device: Monopolar Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Children's Hospital of Michigan:

Primary Outcome Measures:
  • pain

Secondary Outcome Measures:
  • return to normal activity
  • return to normal diet
  • medication dose taken

Estimated Enrollment: 100
Study Start Date: May 2007
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.


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00466544

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
Principal Investigator: David Madgy Detroit Children's Hospital
  More Information Identifier: NCT00466544     History of Changes
Other Study ID Numbers: 036706MP4F
Study First Received: April 26, 2007
Last Updated: April 26, 2007

Keywords provided by Children's Hospital of Michigan:
Chronic tonsillitis
Recurrent tonsillitis

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases processed this record on September 19, 2017