Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy

Status unconfirmed · Phase 4

Conditions studied: Obstructive Tonsillar Hypertrophy, Tonsillitis

In brief

Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.

Key facts

Study ID

NCT00466544

Run by

Children's Hospital of Michigan

People needed

100

Starts

2007-05-01

Last updated by the study team

2007-04-27

Who can join

Age: 4 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Detroit Children's Hospital — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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