NCT06326983

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery; a Randomized, Controlled, Non-inferiority Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tonsillitis
• Post-operative Nausea and Vomiting (PONV)
• Emergence Delirium
• Opioid Analgesic Adverse Reaction
• Anesthesia
• Pain

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia
DRUG	Acetaminophen	Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).
DRUG	Ketorolac	Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
DRUG	Morphine	Morphine (0.1mg/kg given intravenously at induction of anesthesia)

Timeline

• Start date: 2024-05-09
• Primary completion: 2026-02-28
• Completion: 2026-04-01
• First posted: 2024-03-25
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States