Status:
UNKNOWN
Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
Lead Sponsor:
Children's Hospital of Michigan
Conditions:
Obstructive Tonsillar Hypertrophy
Tonsillitis
Eligibility:
All Genders
4-16 years
Phase:
PHASE4
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00466544
Start Date
May 1 2007
Last Update
April 27 2007
Active Locations (1)
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1
Detroit Children's Hospital
Detroit, Michigan, United States, 48201