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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Children's Hospital of Michigan.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Children's Hospital of Michigan
ClinicalTrials.gov Identifier:
NCT00466544
First received: April 26, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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-Blind
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.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466544

Locations
United States, Michigan
Detroit Children's Hospital Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: David Madgy    313-745-9048    dnmadgy@comcast.net   
Contact: Mary Ross    (313) 745-9050    mmross@dmc.org   
Principal Investigator: David Madgy         
Sponsors and Collaborators
Children's Hospital of Michigan
Investigators
Principal Investigator: David Madgy Detroit Children's Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00466544     History of Changes
Other Study ID Numbers: 036706MP4F
Study First Received: April 26, 2007
Last Updated: April 26, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertrophy
Tonsillitis
Pathological Conditions, Anatomical
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 29, 2014