Status:
TERMINATED
Opioid-Free Anesthetic for Tonsillectomy
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
University of Pennsylvania
University of Tennessee
Conditions:
Anesthesia
Opioid Use
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
Brief 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 sig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04528173
Start Date
July 22 2020
End Date
August 22 2023
Last Update
December 20 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
2
University of Tennessee Health Science Center; St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105