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Peak(R) vs. Electrocautery in Children Undergoing Tonsillectomy With Adenoidectomy

NCT02533999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-02-22

Study results available
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Summary

Given the large numbers of children who undergo tonsillectomy (by the time a child is 15 years old, 13% of his/her peers will have had a tonsillectomy), the significant morbidity, and direct and indirect costs associated with absences for child from school or parent from work or other responsibilities, it is vitally important to identify surgical techniques which will minimize pain and serious negative outcomes. This study aims to compare a new surgical technique, PEAK® Surgery System, with electrocautery, one of the most commonly used methods for tonsillectomy with or without adenoidectomy in children 3 to 6 years old with a diagnosis of sleep-disordered breathing.

In this project, the investigator will evaluate intra-operative outcomes including, surgery time and bleeding rates, and post-operative pain scores, bleeding rates, time to resumption of normal diet and activity, analgesic type and use, and frequency of emergent visits over 14 days following surgery.

The hypothesis is that there is no difference in outcomes between the traditional extracapsular electrocautery dissection method of tonsillectomy versus the newly introduced Peak® Surgery System.

The long-term goal is to minimize pain and risk of bleeding and shorten the time to resumption of normal eating and activities in children undergoing tonsillectomy.

Conditions

  • Sleep Disordered Breathing

Interventions

DEVICE

PEAK® Plasma System

Surgical method for tonsillectomy and adenoidectomy.

DEVICE

Electrosurgery

Surgical method for tonsillectomy and adenoidectomy.

Sponsors & Collaborators

  • Baptist Health Wolfson Children's Hospital

    collaborator UNKNOWN

  • Baptist Health Wolfson Surgery Center

    collaborator UNKNOWN

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Kathryn Blake, PharmD · Nemours Children's Specialty Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-08-31
Completion
2016-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02533999 on ClinicalTrials.gov