Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery
Key facts
- Who runs it
- Boston Children's Hospital
- Where
- Waltham, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 62 people enrolled
- Started
- 9 May 2024
- Ended
- 1 Mar 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dexmedetomidine
- Acetaminophen
- Ketorolac
- Morphine
- Record updated
- 18 May 2026
Who can take part
- Age
- 3 years to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- Patients not scheduled for primary tonsillectomy/tonsillotomy
- Patients with known coagulopathies
Where in United States
- Boston Children's HospitalWaltham, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Opioid-Sparing Anesthetic PlanTreatment being tested
For their tonsil surgery, subjects will receive Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia) and 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 given intravenously at the end of surgery. No opioids will be given during the procedure.
Treatment: Dexmedetomidine, Acetaminophen, and Ketorolac
- Opioid Anesthetic PlanExisting treatment, for comparison
For their tonsil surgery, subjects will receive Morphine (0.1mg/kg given intravenously at induction of anesthesia) and 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.
Treatment: Acetaminophen, Ketorolac, and Morphine
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery; a Randomized, Controlled, Non-inferiority Study
- Record updated
- 18 May 2026