Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

NCT ID: NCT06326983

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-09

Study Completion Date

2026-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Acetaminophen

Intervention Type DRUG

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

Ketorolac

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

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

Ketorolac

Intervention Type DRUG

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

Morphine

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Acetaminophen

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

Intervention Type DRUG

Ketorolac

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

Intervention Type DRUG

Morphine

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

Intervention Type DRUG

Other Intervention Names

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Precedex Ofirmev Toradol

Eligibility Criteria

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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)
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Arielle Mizrahi-Arnaud

MD, Anesthesia, Critical Care and Pain Medicine, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital

Waltham, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jocelyn Booth, BSN

Role: CONTACT

857-218-4585

Samuel Kim, BS

Role: CONTACT

617-919-3692

Facility Contacts

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Arielle Mizrahi-Arnaud, MD

Role: primary

617-355-7737

Other Identifiers

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IRB-P00047028

Identifier Type: -

Identifier Source: org_study_id

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