Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy (NCT00466544) | Clinical Trial Compass
UnknownPhase 4
Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
United States100 participantsStarted 2007-05
Plain-language summary
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.
Who can participate
Age range4 Years – 16 Years
SexALL
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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.