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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-24 hours post-operatively

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Emergence Delirium

Intraoperative Blood pressure (mmHg)

Intraoperative Heart rate (beats per second)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2050

Acetaminophen

2017

Completed Phase 4

~2030