Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy

Tonsillitis Clinical Trial

— jPK  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00466544
• Other study ID #: 036706MP4F
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 26, 2007
• Last updated: April 26, 2007
• Start date: May 2007

Study information

• Verified date: March 2007
• Source: Children's Hospital of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophy
• Obstructive Tonsillar Hypertrophy
• Tonsillitis

Intervention

Device:
• Plasmaknife

• Monopolar

Locations

Country	Name	City	State
United States	Detroit Children's Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain
Secondary	return to normal activity
Secondary	return to normal diet
Secondary	medication dose taken