Perioperative Tonsillectomy Protocol Development
Perioperative Tonsillectomy Protocol Development
Pediatric patients who are undergoing a tonsillectomy at the Children's hospital will be
 randomly assigned to one of three drug groups: 1) acetaminophen (Tylenol) administered
 pre-operatively and a low dose of anti-inflammatory drug (dexamethasone) administered
 intra-operatively; 2) acetaminophen (Tylenol) administered pre-operatively and a high dose of
 anti-inflammatory drug (dexamethasone) administered intra-operatively; 3) no acetaminophen
 (Tylenol) administered pre-operatively, low dose anti-inflammatory (dexamethasone)
 administered intra-operatively. The present study will evaluate differences in pain
 management and surgical complications across the three groups of drug regimens. Main study
 outcomes include: pain medication administration during surgery, use of pain killers at
 1-week post-operation, subjective pain scores administered in the post-anesthesia care unit
 (PACU) and 1 week postoperation, fluid and food intake, and complication rates (i.e.
 postoperative bleed rate). The hypothesis is that pain will be lowest in the group that
 received Tylenol and high-dose dexamethasone (Group 2).
This study will be conducted as a prospective, randomized, longitudinal, double-blinded trial
 at a single ambulatory surgery centre with 3 groups of 20 children. Group 1 will receive oral
 acetaminophen (15 mg/kg) 1 hour pre-operatively and high-dose intravenous dexamethasone (0.5
 mg/kg, max. dose 10 mg) immediately after induction of anesthesia. Group 2 will receive oral
 acetaminophen elixir (15 mg/kg) 1 hour pre-operatively and low-dose intravenous dexamethasone
 (0.15 mg/kg, maximum of 8 mg) immediately after induction of anesthesia. Group 3 will receive
 an oral placebo 1 hour pre-operatively and low dose intravenous dexamethasone (0.15 mg/kg,
 maximum of 8 mg) immediately after induction of anesthesia. Dose of dexamethasone is a
 potential confounder if patients in the low-dose dexamethasone groups weigh enough to obtain
 the maximum dose (8 mg). We expect this occurrence to be rare, as dexamethasone will be dosed
 for ideal bodyweight, but subgroup analysis by actual dose received will be performed to
 compare the two dosing regimens (0.15mg/kg and 0.5 mg/kg).

 In addition to these medications, patients will receive the standard peri-operative care at
 our centre, which consists of intra- operative ondansetron at the discretion of the
 anesthesiologist, and standing orders for acetaminophen (15 mg/kg) and ibuprofen (10 mg/kg)
 around the clock. Patients older than five years also receive morphine elixir (0.1 mg/kg
 rounded down to the nearest 0.5 mg) p.r.n (when necessary) at the discretion of the nurse.
 Thus, patients of all three groups will receive adequate post-operative symptom control. The
 Pediatric Otolaryngologist (Dr. Josee Paradis, Dr. Julie Strychowsky, or Dr. Murad Husein)
 who is the patient's physician and will be performing the tonsillectomy, will initially
 approach the participant and substitute decision maker (SDM) to describe the study. If the
 patient and SDM agree to consider the study, the study will be described in more detail and
 study consent/assent will be obtained by a research assistant or a physician (who is not the
 primary physician). We will recruit a convenience sample of 60 patients aged 3-13 years
 scheduled for tonsillectomy to be performed by the principal investigator or co-investigators
 (J.P., M.H. or J.S.). For children aged 3 to 6 years, SDM informed consent will be obtained;
 for children aged 7 to 12 years, SDM written consent and child assent will be requested; for
 children 13 years of age, written consent will be obtained from a SDM and from the child. The
 patients will be randomized to one of the three treatment groups by a computerized
 randomization table. Data from the tonsillectomy procedure, including whether analgesia was
 needed intraoperatively, and in the post-anesthesia care unit, will be recorded.
 Self-reported pain intensity will be scored on the Oucher tool, a number and picture scale
 validated in children age 3-13. A research assistant or nurse will be trained to obtain
 Oucher reports at the patient's bedside at specific post-operative events, which correspond
 to time points. The Oucher tool is simple to learn and takes minimal time to administer. The
 first pain report will be obtained once the patient wakes from anesthesia (15 - 45 min post-
 operation), then upon transfer to step-down care (1 - 2 hrs hour post-operation), then at 3
 hours post-operation, and finally upon discharge (or at 5 hours post-operation, if the
 patient is not anticipated to be discharged by this time). Many of the details surrounding
 the operation will be gathered in post-hoc review of the patient's chart by the research
 assistant. If the patient is transferred from the PACU to the day surgery unit (i.e.
 discharge is anticipated before the end of the day), the information from the entire stay in
 the day surgery will be collected. If the patient is admitted to the floor (i.e. staying
 overnight in the hospital for observation), information will be collected from the first 4
 hours after admission. The information gathered from the chart will include complications of
 surgery, whether or not the patient had post-operative bleeding requiring a change in
 management, and also whether or not the patient had post-operative bleeding that required an
 operating room procedure. Time to first oral fluid intake, as well as amount of oral intake
 (measured in quantity of popsicles) in the post-anesthesia care unit and total oral intake
 before discharge will also be gathered from the patient's chart, as well as the time to first
 administration of morphine, the dose of morphine required, and the frequency of
 post-operative vomiting until time of discharge. For home pain management, all patients are
 advised to take acetominophen (15mg/kg) every 6 hours as needed, alternating with ibuprofen
 (10mg/kg) every 6 hours as needed. At discharge (average 5 hours post-operation),
 parents/guardians will be provided with a package including the Pediatric Quality of Life
 Inventory with questions about oral intake and activity, as well as a space to record any
 incidents of vomiting, the Oucher tool to evaluate the patient's pain severity, and a
 medication log to keep track of the pain medication (over the counter or prescribed) that the
 patient has taken. Parents/guardians will be given a measured cup to record quantity of oral
 fluid intake for the day. Parents will be asked to fill out the first questionnaire at
 discharge (average 5 hours post-operation) time point, and they will be encouraged to raise
 any questions or concerns they have about how to complete the questionnaires. Subsequently,
 these instruments will be completed by parents/guardians (relationship to patient will be
 noted on each form and they will be encouraged to have the same parent/guardian complete the
 form each time) on post-operative days 1, 2, 3, 4, 5, 6, and 7 before bedtime. The research
 assistant will contact parents/guardians and patients by telephone on the first postoperative
 day to follow-up with any questions or concerns about the survey. On the last weekday before
 the patient's follow-up appointment, a reminder call will be made to ask the parent/guardian
 to bring their completed questionnaire to the appointment. On the 14th post-operative day
 patients will attend a follow-up visit where they will be assessed and their completed forms
 will be collected. If the patient had any emergency department visits related to the
 procedure, the research assistant will consult the hospital database to obtain information
 about the emergency department visit, including date, chief complaint, and management.
Inclusion Criteria:

 -  Healthy patients

 -  aged 3-13 years

 -  Level I or level II on the American Society of Anesthesiologists (ASA) physical status
 classification system (as determined by the anesthesiologist)

 -  obstructive sleep apnea or recurrent throat infections

 -  undergoing elective tonsillectomy with or without adenoidectomy

 -  Parents who agree to complete documentation and follow up at 14 days post-operation.

 Exclusion Criteria:

 -  Patients Level III or greater on the American Society of Anesthesiologists (ASA)
 physical status classification system (as determined by the anesthesiologist)

 -  Patients with chronic conditions that would limit our ability to develop the study
 according to objectives, such as neurodevelopmental conditions preventing patients
 from understanding the Oucher tool

 -  Hepatic or renal disease

 -  cardiac disease

 -  active infection

 -  diabetes mellitus

 -  sickle cell disease

 -  known coagulation disorders

 -  pre- operative treatment with anti-emetics, steroids, or analgesics

 -  Acetaminophen allergy or already receiving acetaminophen within 24 h of surgery

 -  Complicating health factors precluding the use of opioids or acetaminophen

 -  any other factors which would interfere with pain assessment and management

 -  Patients weighing more than 30 kg that would exceed maximum dexamethasone dose

 -  Patients who live without a home telephone

 -  patient living without parental supervision.