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Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

NCT06326983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-05-18

No results posted yet for this study

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

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)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06326983 on ClinicalTrials.gov