Overview

Perioperative Tonsillectomy Protocol Development

Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
London Health Sciences Centre
Treatments:
Acetaminophen
Anesthetics
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
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.