drugset / Trial / NCT06326983

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

NCT06326983

Completed 62 enrolled Boston Children's Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.

Timeline

Start
2024-05-09
Primary completion
2026-01-30
Completion
2026-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 1 ug/kg Intravenous
Comparator Morphine Other / unclassified 0.1 mg/kg Intravenous
Background Acetaminophen Small molecule 12.5 mg/kg Intravenous
Background Ketorolac Other / unclassified 0.5 mg/kg Intravenous

Indications