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
Boston Children's Hospital
58 participants
May 9, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- American Society of Anesthesia classification status I-III
- Ages 3 years to 17 years
- Scheduled for tonsillectomy or tonsillotomy with or without adenoidectomy at Boston Children's Hospital Waltham
Exclusion Criteria4
- Patients not scheduled for primary tonsillectomy/tonsillotomy.
- Patients with known coagulopathies
- Patients with previous chronic pain syndromes
- Patients with any condition/indication that would prevent them from being able to be randomized (i.e. allergy to one of the study medications)
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Interventions
Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia
Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).
Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
Morphine (0.1mg/kg given intravenously at induction of anesthesia)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06326983