RECRUITING

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-09
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06326983

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * American Society of Anesthesia classification status I-III
  2. * Ages 3 years to 17 years
  3. * Scheduled for tonsillectomy or tonsillotomy with or without adenoidectomy at Boston Children's Hospital Waltham
  1. * Patients not scheduled for primary tonsillectomy/tonsillotomy.
  2. * Patients with known coagulopathies
  3. * Patients with previous chronic pain syndromes
  4. * Patients with any condition/indication that would prevent them from being able to be randomized (i.e. allergy to one of the study medications)

Contacts and Locations

Study Contact

Jocelyn Booth, BSN
CONTACT
857-218-4585
jocelyn.booth@childrens.harvard.edu
Samuel Kim, BS
CONTACT
617-919-3692
samuel.kim@childrens.harvard.edu

Study Locations (Sites)

Boston Children's Hospital
Waltham, Massachusetts, 02453
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-09
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2024-05-09
Study Completion Date2026-04-01

Terms related to this study

Additional Relevant MeSH Terms

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