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Opioid-Free Anesthetic for Tonsillectomy | Clinical Trials | Clareo Health

TERMINATEDPHASE4

Opioid-Free Anesthetic for Tonsillectomy

Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy

NCT04528173•Children's Hospital of Philadelphia

Summary

Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic

Detailed Description

Objectives: Primary: To determine if an opioid-free anesthetic provides equivalent acute postoperative pain relief in tonsillectomy. Secondary: To determine if post-operative pain at home is not significantly different with an opioid-free regimen compared to an opioid containing regimen for tonsillectomy. Study Design: Prospective, randomized, multi-center trial study Study Interventions and Measures: Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group The primary endpoint is the median pain score (calculated by a blinded validated observer in the recovery room at two time intervals) between the two cohorts.

Eligibility

Age

2 - 18 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males or females age 2 to 18 years.
•2. American Society of Anesthesiologists {ASA) ≤ 3 physical classification system
•3. Girls after menarche must have a negative pregnancy test.
•4. Scheduled tonsillectomy or tonsillectomy combined with adenoidectomy and/or ear tube placement at the Children's Hospital of Philadelphia (CHOP) main or ambulatory surgical centers.
•5. Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria

•1. Current (Within the last 30 days) opioid use for pain control
•2. High risk for surgical site hemorrhage, determined by bleeding disorder diagnosis or evidence or poor hemostasis
•3. Multiple scheduled surgeries at the same time other than adenoidectomy and/or ear tube placement
•4. History of drug abuse, chronic pain, bleeding disorder
•5. Chronic disease such as sickle cell disease for which treatment with opioids may be clinically indicated
•6. Significant congenital disorders, medication allergies or comorbidities, specifically a pre-disposition to bradycardia or conduction abnormalities, cyanotic cardiac disease and use of medications that would increase risk of bleeding or bradycardia.
•7. History of hepatic dysfunction, renal dysfunction, thrombocytopenia, or anemia (including pre-surgery laboratory abnormalities)
•8. History of hypersensitivity to NSAIDs
•9. Patients with asthma, including patients who have experienced aspirin- or NSAID-sensitive asthma or a history of exacerbation when aspirin or NSAIDs are administered (e.g. bronchospasm, urticaria, etc.)
•10. Subjects receiving medications that could impact metabolism of either study drug should also be excluded
+4 more criteria

Locations (2)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Tennessee Health Science Center; St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Key Dates

Start Date

July 22, 2020

Primary Completion Date

August 22, 2023

Completion Date

August 22, 2023

Last Updated

December 20, 2024

Enrollment

ACTUAL participants

Conditions

AnesthesiaOpioid UseTonsillitisSleep DisorderSurgery

Interventions

Ketorolac

DRUG

Dexmedetomidine

DRUG

Morphine

DRUG

Fentanyl

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Opioid-Free Anesthetic for Tonsillectomy

Inclusion Criteria

Exclusion Criteria

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