Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery (NCT06326983) | Clinical Trial Compass
CompletedNot Applicable
Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery
United States62 participantsStarted 2024-05-09
Plain-language 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.
Who can participate
Age range
3 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Median Pain Scores in the Post-Anesthesia Care Unit
Timeframe: entry to post-anesthesia care unit to 2-6 hours post-operatively
2
Post-operative pain at 12-24 hours
Timeframe: 12-24 hours post-operatively
3
Post Operative Anesthesia Unit Length of Stay (hours)
Timeframe: From entry to the Post Anesthesia Care Unit to exit from the Post-Anesthesia Care Unit. Assessed for up to 8 hours on the date of surgery