Opioid-Free Anesthetic for Tonsillectomy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    550
  • sponsor
    Children's Hospital of Philadelphia
Updated on 9 September 2021
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 IdentifierNCT04528173
SponsorChildren's Hospital of Philadelphia
Last Modified on9 September 2021

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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