Peak(R) vs. Electrocautery in Children Undergoing Tonsillectomy With Adenoidectomy
Condition: Sleep Disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes
Study type: Interventional

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.
    

Detailed description: 
      SPECIFIC AIMS:

        -  Specific Aim 1: To assess differences in pain control, assessed by validated pain scores
           and requirement for postoperative analgesia, during the 14-day post-operative period.

        -  Specific Aim 2: To assess differences in bleeding (hemorrhage) both intraoperatively and
           24 hours post-surgery (immediate period) and between 24 hours and 14 days
           post-operatively (delayed period).

        -  Specific Aim 3: To assess differences in other outcomes (time to resumption of normal
           diet and activities) and adverse events (emergent visits for medical care) between 24
           hours and 14 days post-operatively.

      BACKGROUND AND SIGNIFICANCE:

      Epidemiology of Tonsillectomy in Children. Tonsillectomy is the second most commonly
      performed procedure in children under 15 years old, second to myringotomy and pressure
      equalization tube placement. It is estimated that 583,000 outpatient tonsillectomy procedures
      were performed in children in the US in 2006 accounting for 16% of all ambulatory surgeries
      with the greatest number (103/10,000) in children ages 0 to 6 years old. In this age group,
      diagnosis of airway obstruction or sleep disturbance accounts for the majority of surgery
      indications and tonsillectomy with adenoidectomy account for 90% of the procedures performed
      (vs. 10% for tonsillectomy alone). Nemours Jacksonville surgeons performed 995
      tonsillectomies with/without adenoidectomy at Wolfson Children's Hospital in children 3 to 6
      years old with sleep-disordered breathing from 2010-2011.

      In this project, the investigators will compare electrocautery surgical method with the PEAK®
      Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device]
      (Medtronic, Inc), a recently marketed device. There are no published studies comparing the
      PEAK® system with other traditional methods of performing adenotonsillectomy. Nemours
      otolaryngologists currently use the PEAK® system for adenotonsillectomies in children 3 to 18
      years of age with a diagnosis of sleep-disordered breathing. 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. Data from the Medtronic website indicates the temperature profile from the PEAK®
      system to be approximately half that associated electrosurgery at similar cut settings; and
      human studies indicate a 66% to 80% reduction in thermal injury depth.

      PRELIMINARY STUDIES:

      There are no preliminary data from Nemours using the Peak® Plasma System.

      APPROACH:

      1. Study Design This is a prospective, randomized, single-blind controlled study. Patients
      and caregivers and the study coordinator will be blinded to the surgical method.

      This project will involve a single study visit and 6 phone calls and completion of daily
      diaries for 14 days following surgery and completion of the Glasgow Children's Benefit
      Inventory 7 6-months after surgery. Parents and caregivers will be contacted after the
      surgery date is scheduled to discuss the project and determine interest. If interested, and
      inclusion/exclusion criteria are met, families will be advised of the study and invited to
      participate. Parental permission will be obtained from the parent/caregiver prior to surgery.
      Children aged 3 to 18 years old will be included.

      Stopping Criteria: The study will be stopped and unblinded if the rate of postoperative
      hemorrhage, defined as Level II or Level III, exceeds 2 participants in the same surgical
      group assessed during the first 5-days post-operatively after the first 30 patients have been
      enrolled. Post-operative bleeding will be defined 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. This level excludes children undergoing
      evaluation in the emergency department for reported postoperative hemorrhage who have no
      evidence of clot formation or hemorrhage and are deemed safe for discharge.

      Level III. All children who require a return to the operating department for control of
      postoperative bleeding.

      Patients will be instructed to call the clinic if there is more than one tablespoon of blood
      in a single episode or persistent bleeding of small amounts throughout the day.
      Administration of dexamethasone perioperatively has been found to not increase the risk of
      Level II or Level III bleeds in a recent study.

      Randomization Children will be randomized in a block design such that an equal number of
      children are randomized to electrocautery or PEAK® Plasma System for each surgeon. Caregivers
      will be blinded to surgical technique. The surgeon will have no input into which device a
      child is randomized. The study coordinator will be blinded as to which device the child was
      randomized.

      Surgical Techniques and Post-Operative Care Surgical Procedure: Patients will be prepped as
      usual for routine adenotonsillectomy procedure. The procedure will be performed under general
      anesthesia by a fellowship trained pediatric anesthesiologist. All patients will receive
      0.5mg/kg dose of intravenous dexamethasone (maximum 15mg) 11 at the onset of the procedure.
      Patients requiring adenoidectomy will undergo either curette removal followed by suction
      electrocautery or ablation by suction electrocautery alone. Adenoidectomy technique will be
      based upon the size of the adenoid pad where enlarged adenoids routinely employ the curette.

      Most children in this age group will receive a premedication of midazolam 0.5 mg/kg prn for
      anxiety. General anesthesia will be induced by face mask, with sevoflurane, nitrous oxide and
      oxygen. A peripheral IV will be started and intravenous fentanyl (1-2 ug/kg) will be
      administered. Propofol may be administered at the discretion of the anesthesiologist. The
      patient's trachea will be intubated under direct laryngoscopy. The patient will also receive
      IV dexamethasone, ondansetron, and additional fentanyl, if needed. The maintenance anesthetic
      will include desflurane, with nitrous oxide and oxygen. At the end of the surgery the
      patient's trachea will be extubated when the patient is awake. Post-op rescue analgesics will
      include fentanyl and /or morphine.

      Instrument Settings: Settings and methods for electrocautery and the PEAK® Plasma System will
      be standardized between the surgeons. For the PEAK® Plasma System, the 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. For electrocautery, the setting will be standardized to 12
      for tonsils and 30 for adenoids.

      Data Collected Intra-operatively Total blood loss will be determined by the method described
      by Walner, et al in which the operating nurse will record the blood loss based on the amount
      in the suction canister or suction tubing at the conclusion of each procedure. Data
      extraction of blood loss from the operative report will be performed by the data entry
      specialist and not the study coordinator to prevent unblinding of the study coordinator. The
      Biomedical Research Department has several highly trained data entry specialists who extract
      clinical data from the EHR.

      Data Collected Post-operatively Parents will complete a diary card beginning on the day of
      surgery and continuing for 14 days. After 30±4 days following surgery, the study coordinator
      will contact parent of each patient by telephone to obtain information on incidence of
      late-complications and to collect a global assessment of the parent's perception of the
      30-day postoperative period. Assessment will consist of asking parents to state whether their
      child's pain had been less, the same, or more than they had expected it to be after the
      adenotonsillectomy. At this assessment, the coordinator and parents will still be blinded to
      the treatment received. At six-months post-operatively, parents will be mailed the Glasgow
      Children's Benefit Inventory (GCBI). Unblinding information will be mailed to parents 2 weeks
      after the GCBI has been mailed.

      The following measures will be collected daily on the diary card beginning on Day 0 (day of
      surgery):

        1. Presence of bleeding.

           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. This level excludes children
                undergoing evaluation in the emergency department for reported postoperative
                hemorrhage who have no evidence of clot formation or hemorrhage and are deemed safe
                for discharge.

             -  Level III. All children who require a return to the operating department for
                control of postoperative bleeding.

           Children who return to the emergency department (ED) or hospital who are subsequently
           diagnosed with Von Willebrand's disease will be excluded from the study and will not be
           included in the data analysis.

        2. 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 13 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.

        3. Type and frequency of pain medication will be recorded.

        4. 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.

        5. 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.

        6. At each post-operative phone call, the study coordinator will collect data regarding
           bleeding events with the questions below and document parental phone calls or visits to
           physician regarding parental concerns over child's recovery.

      Data Collected After 6-Months Six months following surgery, parents will be mailed the
      Glasgow Children's Benefit Inventory (GCBI) 7. The GCBI is a post intervention health-related
      benefit measure consisting of 24 broadly worded yes/no questions that are applicable to any
      area of pediatric medicine. The GCBI scores will be compared between surgical techniques. The
      two study groups will be matched for age and sex.
    

Intervention name(s): PEAK® Plasma System; Electrosurgery
Intervention type(s): Device; Device
Intervention description(s): Surgical method for tonsillectomy and adenoidectomy.; Surgical method for tonsillectomy and adenoidectomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment