Opioid-Free Anesthetic for Tonsillectomy

STATUS

Recruiting
End date

Dec 31, 2023
participants needed

550
sponsor

Children's Hospital of Philadelphia

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Updated on 9 September 2021

See if I qualify

morphine

dexmedetomidine

opioid

tonsillectomy

tube placement

ketorolac

adenoidectomy

Summary

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

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.

Details

Condition	Anesthesia, sleep disorder, anaesthesia, Sleep Disorders, Tonsillitis, surgical procedure, anesthesia procedures, surgeries, anesthesia for, Anesthesia (Local), Narcotic Use, Surgery, dental anesthesia, surgical treatment, Opioid Use, sensory loss, Surgical aspects, Pharyngitis, surgical procedures, Sleep Disorders (Pediatric)
Treatment	Dexmedetomidine, Fentanyl, ketorolac, Morphine
Clinical Study Identifier	NCT04528173
Sponsor	Children's Hospital of Philadelphia
Last Modified on	9 September 2021

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Males or females age 2 to 18 years
	American Society of Anesthesiologists {ASA) 3 physical classification system
	Girls after menarche must have a negative pregnancy test
	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
	Parental/guardian permission (informed consent) and if appropriate, child assent
Exclusion Criteria
	Current (Within the last 30 days) opioid use for pain control
	High risk for surgical site hemorrhage, determined by bleeding disorder diagnosis or evidence or poor hemostasis
	Multiple scheduled surgeries at the same time other than adenoidectomy and/or ear tube placement
	History of drug abuse, chronic pain, bleeding disorder
	Chronic disease such as sickle cell disease for which treatment with opioids may be clinically indicated
	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
	History of hepatic dysfunction, renal dysfunction, thrombocytopenia, or anemia (including pre-surgery laboratory abnormalities)
	History of hypersensitivity to NSAIDs
	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.)
	Subjects receiving medications that could impact metabolism of either study drug should also be excluded
	Trisomy 21 diagnosis
	Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
	Patients on a Ketogenic diet
	Parents or subjects who do not speak English

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Opioid-Free Anesthetic for Tonsillectomy