Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

NCT06326983 | Recruiting DMC

• 1 other identifier: IRB-P00047028
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tonsillitis; Post-operative Nausea and Vomiting (PONV); Emergence Delirium; Opioid Analgesic Adverse Reaction; Anesthesia; Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Opioid rescue medication administration

  surgery end to 2-6 hours post-operatively

• Emergence Delirium

  surgery end to 2-6 hours post-operatively

• Post-operative nausea and vomiting

  surgery end to 2-6 hours post-operatively

• Procedure length (minutes)

  0-60 minutes

• Intraoperative Blood pressure (mmHg)

  10 minutes

Study Arms (2)

Opioid-Sparing Anesthetic Plan

EXPERIMENTAL

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; Drug: Acetaminophen; Drug: Ketorolac

Opioid Anesthetic Plan

ACTIVE COMPARATOR

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; Drug: Ketorolac; Drug: Morphine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia

Also known as: Precedex

Opioid-Sparing Anesthetic Plan

Acetaminophen DRUG

Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).

Also known as: Ofirmev

Opioid Anesthetic Plan; Opioid-Sparing Anesthetic Plan

Ketorolac DRUG

Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.

Also known as: Toradol

Opioid Anesthetic Plan; Opioid-Sparing Anesthetic Plan

Morphine DRUG

Morphine (0.1mg/kg given intravenously at induction of anesthesia)

Opioid Anesthetic Plan

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Waltham, Massachusetts, 02453, United States

RECRUITING

MeSH Terms

Conditions

Tonsillitis; Vomiting; Emergence Delirium; Pain

Interventions

Dexmedetomidine; Acetaminophen; Ketorolac; Ketorolac Tromethamine; Morphine

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Jocelyn Booth, BSN

CONTACT

857-218-4585; jocelyn.booth@childrens.harvard.edu

Samuel Kim, BS

CONTACT

617-919-3692; samuel.kim@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesia, Critical Care and Pain Medicine, Principal Investigator

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 25, 2024
• Study Start: May 9, 2024
• Primary Completion: February 28, 2026
• Study Completion: April 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)