Opioid-Free Anesthetic for Tonsillectomy (NCT04528173) | Clinical Trial Compass
TerminatedPhase 4
Opioid-Free Anesthetic for Tonsillectomy
Stopped: Difficulty with enrollment
United States35 participantsStarted 2020-07-22
Plain-language summary
Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic
Who can participate
Age range2 Years – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✕
What they're measuring
1
Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score