Status:
UNKNOWN
Perioperative Tonsillectomy Protocol Development
Lead Sponsor:
London Health Sciences Centre
Conditions:
Tonsillitis
Eligibility:
All Genders
3-13 years
Phase:
PHASE4
Brief 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 lo...
Detailed Description
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 acetaminophe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03323047
Start Date
March 1 2018
End Date
September 1 2021
Last Update
February 18 2021
Active Locations (1)
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1
Children's Hospital
London, Ontario, Canada