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

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ClinicalTrials.gov Identifier: NCT02533999
Recruitment Status : Completed
First Posted : August 27, 2015
Results First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Collaborators:
Baptist Health Wolfson Children’s Hospital
Baptist Health Wolfson Surgery Center
Information provided by (Responsible Party):
Kathryn Blake, PharmD, Nemours Children's Clinic

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.


Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Device: PEAK® Plasma System Device: Electrosurgery Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Assessment of 14-Day Outcomes With the Peak® Surgery System Versus the Traditional Electrocautery Method in Children Ages 3 to 18 Years Undergoing Tonsillectomy With Adenoidectomy for Sleep Disordered Breathing
Study Start Date : April 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis

Arm Intervention/treatment
Experimental: Surgical Instrument
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
Surgical method for tonsillectomy and adenoidectomy.

Active Comparator: Electrosurgery
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
Surgical method for tonsillectomy and adenoidectomy.




Primary Outcome Measures :
  1. Pain Control Assessed by Validated Pain Scores: Days to Having no Pain Following Surgery [ Time Frame: during the 14-day post-operative period ]

    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.



Secondary Outcome Measures :
  1. Number of Participants Who Experienced Bleeding Intraoperatively and 24 Hours Post-surgery (Primary Period) [ Time Frame: intraoperatively and 24 hours post-surgery (primary period) ]

    To assess differences in bleeding (hemorrhage) rate (either Level I, Level II, or Level III) intraoperatively and 24 hours post-surgery (primary period) in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.

    Post-operative bleeding will be scored as follows:

    Level I. All children who report to have any history of postoperative hemorrhage, whether or not there is clinical evidence.

    Level II. All children who require inpatient admission for postoperative hemorrhage regardless of the need for operative intervention.

    Level III. All children who require a return to the operating department for control of postoperative bleeding.


  2. Number of Participants Who Experienced Bleeding Between 24 Hours and 14 Days Post-operatively (Secondary Period) [ Time Frame: between 24 hours and 14 days post-operatively (secondary period) ]

    To assess differences in bleeding (hemorrhage) rate (either Level I, Level II, or Level III) between 24 hours and 14 days post-operatively (secondary period) in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.

    Post-operative bleeding will be scored as follows:

    Level I. All children who report to have any history of postoperative hemorrhage, whether or not there is clinical evidence.

    Level II. All children who require inpatient admission for postoperative hemorrhage regardless of the need for operative intervention. Level III. All children who require a return to the operating department for control of postoperative bleeding.


  3. Days to Resumption of Normal Diet [ Time Frame: from discharge to 14 days post-operatively ]

    To assess differences in other outcomes (time to resumption of normal diet) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.

    Return to normal diet. Normal diet is defined as consumption of the types and amount of food such that another family member would not be able to recognize that the patient had undergone throat surgery. Dietary progression from liquid to soft and solid food will be also documented. Diet will be scored as 1, liquids and soft diet only; 2, some solids; 3, mostly solids; and 4, normal diet.


  4. Days to Resumption of Normal Activities [ Time Frame: from discharge to 14 days post-operatively ]

    To assess differences in other outcomes (time to resumption of normal activities) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.

    Return to normal activity. Normal activity is defined as carrying out the same types and amounts of daily activity as before surgery, even if still associated with fatigue. Activity will be scored as 1, none; 2, very little; 3, mostly normal; 4, normal.


  5. Adverse Events (Emergent Visits for Medical Care) [ Time Frame: from discharge to 14 days post-operatively ]
    To assess differences in adverse events (emergent visits for medical care) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.


Other Outcome Measures:
  1. Glasgow Children's Benefit Inventory (GCBI) [ Time Frame: At six-months post-operatively ]
    A composite score of GCBI for each patient will be calculated by assigning the individual question responses a numerical value from -2 to +2, then adding these up, dividing by the number of questions (24), and multiplying by 50 to produce a result on a scale from -100 (maximum harm) to+ 100 (maximum benefit) .



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Clinical diagnosis of sleep disordered breathing or obstructive sleep apnea 10 or recurrent tonsillitis
  3. Presence of adenotonsillar hypertrophy

Exclusion Criteria:

  1. Diagnosis of bleeding disorders*
  2. Craniofacial malformation
  3. Previous adenotonsillectomy
  4. Suspected lymphoma
  5. Developmental delay
  6. Diabetes or any other disease that slows wound healing
  7. Peritonsillar abscess
  8. Expressive language disorder
  9. Hematologic wound healing disorder or necrotizing dermatosis,
  10. Implanted electric device
  11. Mucopolysaccharidosis
  12. Use of nonsteroidal anti-inflammatory drugs in the two weeks prior to the surgery
  13. Allergy to medication(s) used in this protocol
  14. Other planned surgical procedure during this surgical period
  15. Chronic pain disorder
  16. Planned hospital admission

    • We will use the following set of questions to evaluate for bleeding issues. If all are answered "no", then the child will be enrolled. If any are answered "yes", the child will be excluded and the family will be referred for a Hematology consult.

      1. Has your child been told he/she has a bleeding disorder?
      2. Does anyone in the child's family (grandmother, grandfather, mother, father, siblings) have a known bleeding disorder?
      3. Does your child have easy bruising or difficulty stopping bleeding when he/she gets a cut or scratch?
      4. If your child has had had surgery before, did the surgeon indicate that controlling bleeding was difficult or was your child required to come back to the hospital for bleeding control?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533999


Sponsors and Collaborators
Nemours Children's Clinic
Baptist Health Wolfson Children’s Hospital
Baptist Health Wolfson Surgery Center
Investigators
Principal Investigator: Kathryn Blake, PharmD Nemours Children's Specialty Care

Responsible Party: Kathryn Blake, PharmD, Director, Center for Pharmacogenomics and Translational Research, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT02533999     History of Changes
Other Study ID Numbers: 13-13
First Posted: August 27, 2015    Key Record Dates
Results First Posted: February 21, 2018
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes