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Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmaknife | Device | |||
| Monopolar | Device |
| Measure | Description | Time Frame |
|---|---|---|
| pain |
| Measure | Description | Time Frame |
|---|---|---|
| return to normal activity | ||
| return to normal diet | ||
| medication dose taken |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Madgy | Detroit Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit Children's Hospital | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |