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 range
4 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.