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Alpha-2 Adrenergic Agonist

Opioid-Sparing Anesthesia for Pediatric Tonsil Surgery

N/A
Recruiting
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 3 years to 17 years
Scheduled for tonsillectomy or tonsillotomy with or without adenoidectomy at Boston Children's Hospital Waltham
Must not have
Patients with previous chronic pain syndromes
Patients not scheduled for primary tonsillectomy/tonsillotomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-24 hours post-operatively
Awards & highlights

Summary

"This trial is comparing two different pain management plans for patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. One plan uses opioids along with other medications, while the other plan uses less opioids

Who is the study for?
This trial is for children aged 3-17 years scheduled for tonsil surgery at Boston Children's Hospital Waltham. They must be classified as ASA status I-III, indicating they are healthy or have mild to moderate systemic disease.Check my eligibility
What is being tested?
The study compares two anesthesia plans for tonsil surgeries: one uses morphine (an opioid) and the other uses dexmedetomidine (non-opioid), both combined with ketorolac and acetaminophen. It measures pain control, recovery time, and side effects like nausea and delirium.See study design
What are the potential side effects?
Possible side effects include vomiting, emergence delirium from anesthesia, reactions to opioids like respiratory depression or itching, bleeding requiring re-operation, changes in blood pressure during surgery, and need for additional vasopressors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 3 and 17 years old.
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I am scheduled for a tonsil removal surgery at Boston Children's Hospital Waltham.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of chronic pain.
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I am not scheduled for a tonsil removal surgery.
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I have a known blood clotting disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-24 hours post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 hours post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Pain Scores in the Post-Anesthesia Care Unit
Post Operative Anesthesia Unit Length of Stay (hours)
Post-operative pain at 12-24 hours
Secondary outcome measures
Emergence Delirium
Intraoperative Blood pressure (mmHg)
Intraoperative Heart rate (beats per second)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Opioid-Sparing Anesthetic PlanExperimental Treatment3 Interventions
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.
Group II: Opioid Anesthetic PlanActive Control3 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~1980
Acetaminophen
2017
Completed Phase 4
~2030
Ketorolac
2014
Completed Phase 4
~1760

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
773 Previous Clinical Trials
5,580,893 Total Patients Enrolled
3 Trials studying Emergence Delirium
546 Patients Enrolled for Emergence Delirium
~39 spots leftby Dec 2025