Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy

Phase 4

• Conditions: Obstructive Tonsillar Hypertrophy; Tonsillitis

• Registration Number: NCT00466544
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2007-03
• Study First Submitted: 2007-04-26
• Study First Submitted QC: 2007-04-26
• Last Update Submitted: 2007-04-26
• Study First Posted: 2007-04-27
• Last Update Posted: 2007-04-27
• Study Start: 2007-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain

Secondary Outcome Measures

Name	Time	Method
return to normal activity
return to normal diet
medication dose taken

Trial Locations

Locations (1)

Detroit Children's Hospital; 🇺🇸 Detroit, Michigan, United States