drugset / Trial / NCT03323047

Perioperative Tonsillectomy Protocol Development

NCT03323047 ↗

Phase 4 Unknown 60 enrolled London Health Sciences Centre
RandomizedParallel-groupSingle-blindSupportive care

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).

Timeline

Start
2018-03-01
Primary completion
2021-05
Completion
2021-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 15 mg/kg Oral
Comparator Dexamethasone Small molecule 0.15 mg/kg Intravenous
Comparator Dexamethasone Small molecule 0.5 mg/kg Intravenous

Indications