NCT00466544

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
Last Updated

April 27, 2007

Status Verified

March 1, 2007

First QC Date

April 26, 2007

Last Update Submit

April 26, 2007

Conditions

Obstructive Tonsillar HypertrophyTonsillitis

Keywords

Chronic tonsillitisRecurrent tonsillitis

Outcome Measures

Primary Outcomes (1)

  • pain

Secondary Outcomes (3)

  • return to normal activity

  • return to normal diet

  • medication dose taken

Interventions

PlasmaknifeDEVICE
MonopolarDEVICE

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Age GroupsChild (0-17)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Children's Hospital

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • David Madgy

    Detroit Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 27, 2007

Study Start

May 1, 2007

Last Updated

April 27, 2007

Record last verified: 2007-03

Locations

US(1)