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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Emergence Delirium; Anesthesia; Tonsillitis; Opioid Analgesic Adverse Reaction; Post-operative Nausea and Vomiting (PONV)
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Acetaminophen; Drug: Ketorolac; Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02453
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opioid-Sparing Anesthetic Plan; 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.	Drug: Dexmedetomidine; Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia; Other Names: Precedex; Drug: Acetaminophen; Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).; Other Names: Ofirmev; Drug: Ketorolac; Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.; Other Names: Toradol
Active Comparator: Opioid Anesthetic Plan; 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.	Drug: Acetaminophen; Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).; Other Names: Ofirmev; Drug: Ketorolac; Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.; Other Names: Toradol; Drug: Morphine; Morphine (0.1mg/kg given intravenously at induction of anesthesia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Pain Scores in the Post-Anesthesia Care Unit	Median Pain Scores in the Post-Anesthesia Care Unit measured by the numeric rating scale (NRS), Wong-Baker Faces scale or FLACC (Face, Legs, Activity, Cry, Consolability) scale as indicated based on patient age and development. All scales are done on a 0-10 point scale with 0 being no pain and 10 being the highest pain.	entry to post-anesthesia care unit to 2-6 hours post-operatively
Post-operative pain at 12-24 hours	Pain categorized as none, mild, moderate, and severe. Taken from the routine follow-up nursing phone call.	12-24 hours post-operatively
Post Operative Anesthesia Unit Length of Stay (hours)	Length of time spent in the Post Operative Anesthesia Unit after tonsil surgery	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid rescue medication administration	Opioid rescue medications administered (reported as oral morphine equivalents)	surgery end to 2-6 hours post-operatively
Emergence Delirium	Incidence of emergence delirium defined as a score ≥ 10 on the Pediatric Anesthesia Emergence Delirium Scale. Scores range 0-20 with 0 being no agitation/delirium to 20 being the highest level.	surgery end to 2-6 hours post-operatively
Post-operative nausea and vomiting	Incidence of episodes of emesis or administration of anti-emetics in the post-anesthesia care unit	surgery end to 2-6 hours post-operatively
Procedure length (minutes)	from incision time to patient being wheeled out of the operating room	0-60 minutes
Intraoperative Blood pressure (mmHg)	Range of systolic blood pressure within 10 minutes of anesthesia induction	10 minutes
Intraoperative Heart rate (beats per second)	Range of heart rate within 10 minutes of anesthesia induction	10 minutes
Vasopressor administration	Intraoperative administration of vasopressors	0-60 minutes

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Stomatognathic Diseases; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Delirium; Pharyngitis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Pain; Vomiting; Tonsillitis; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Indomethacin; Indoles; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Acetaminophen; Morphine; Ketorolac; Dexmedetomidine; Ketorolac Tromethamine
• Other Study ID Numbers: IRB-P00047028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No