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.