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

NCT02533999 | Completed Results

• 1 other identifier: 13-13
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain Control Assessed by Validated Pain Scores: Days to Having no Pain Following Surgery

  To assess differences in pain control, assessed by validated pain scores and requirement for postoperative analgesia, during the 14-day post-operative period in children ages 3 to 18 years undergoing adenotonsillectomy with a clinical diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method. Assessment of subjective pain. The child will be asked by the parent to grade severity of pain daily using the Wong-Baker FACES pain rating scale in the morning before eating, drinking, or taking analgesics. The Wong-Baker FACES pain rating scale is a 0 to 10 numerical rating scale (0, 2, 4, 6, 8, 10) with faces indicating the level of pain from a happy face at a score of 0 to a crying face at a score of 10. The scale is recommended for children 3 years and older. Type and frequency of pain medication will be recorded.

  during the 14-day post-operative period

Secondary Outcomes (5)

• Number of Participants Who Experienced Bleeding Intraoperatively and 24 Hours Post-surgery (Primary Period)

  intraoperatively and 24 hours post-surgery (primary period)

• Number of Participants Who Experienced Bleeding Between 24 Hours and 14 Days Post-operatively (Secondary Period)

  between 24 hours and 14 days post-operatively (secondary period)

• Days to Resumption of Normal Diet

  from discharge to 14 days post-operatively

• Days to Resumption of Normal Activities

  from discharge to 14 days post-operatively

• Adverse Events (Emergent Visits for Medical Care)

  from discharge to 14 days post-operatively

Other Outcomes (1)

• Glasgow Children's Benefit Inventory (GCBI)

  At six-months post-operatively

Study Arms (2)

Surgical Instrument

EXPERIMENTAL

PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.

Device: PEAK® Plasma System

Electrosurgery

ACTIVE COMPARATOR

Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.

Device: Electrosurgery

Interventions

PEAK® Plasma System DEVICE

Surgical method for tonsillectomy and adenoidectomy.

Surgical Instrument

Electrosurgery DEVICE

Surgical method for tonsillectomy and adenoidectomy.

Electrosurgery

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients are aged 3 up to 18 years old; children younger than 3 years are excluded because of a higher risk of perioperative complications such as requiring an overnight hospitalization and dehydration after discharge resulting in an emergency department visit or hospitalization
• Clinical diagnosis of sleep disordered breathing or obstructive sleep apnea 10 or recurrent tonsillitis
• Presence of adenotonsillar hypertrophy

You may not qualify if:

• Diagnosis of bleeding disorders\*
• Craniofacial malformation
• Previous adenotonsillectomy
• Suspected lymphoma
• Developmental delay
• Diabetes or any other disease that slows wound healing
• Peritonsillar abscess
• Expressive language disorder
• Hematologic wound healing disorder or necrotizing dermatosis,
• Implanted electric device
• Mucopolysaccharidosis
• Use of nonsteroidal anti-inflammatory drugs in the two weeks prior to the surgery
• Allergy to medication(s) used in this protocol
• Other planned surgical procedure during this surgical period
• Chronic pain disorder

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Baptist Health Wolfson Children's Hospital: collaborator
• Baptist Health Wolfson Surgery Center: collaborator

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Electrosurgery

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Results Point of Contact

• Title: Kathryn Blake, PharmD
• Organization: Nemours Children's Specialty Care

kathryn.blake@nemours.org

904-697-3806

Study Officials

• Kathryn Blake, PharmD

  Nemours Children's Specialty Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Pharmacogenomics and Translational Research

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 27, 2015
• Study Start: April 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 22, 2018
• Results First Posted: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share