Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy (jPK)
Recruitment status was Not yet recruiting
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Purpose
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Tonsillar Hypertrophy Tonsillitis |
Device: Plasmaknife Device: Monopolar |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
- pain
- return to normal activity
- return to normal diet
- medication dose taken
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2007 |
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.
Eligibility| Ages Eligible for Study: | 4 Years to 16 Years |
| Genders Eligible for Study: | Both |
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.
Contacts and Locations| United States, Michigan | |
| Detroit Children's Hospital | Not yet recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: David Madgy 313-745-9048 dnmadgy@comcast.net | |
| Contact: Mary Ross (313) 745-9050 mmross@dmc.org | |
| Principal Investigator: David Madgy | |
| Principal Investigator: | David Madgy | Detroit Children's Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00466544 History of Changes |
| Other Study ID Numbers: | 036706MP4F |
| Study First Received: | April 26, 2007 |
| Last Updated: | April 26, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital of Michigan:
|
Chronic tonsillitis Recurrent tonsillitis |
Additional relevant MeSH terms:
|
Hypertrophy Tonsillitis Pathological Conditions, Anatomical Pharyngitis Pharyngeal Diseases |
Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013