Opioid-Free Anesthetic for Tonsillectomy
Anesthesia, Opioid Use, Tonsillitis
About this trial
This is an interventional treatment trial for Anesthesia focused on measuring Tonsillectomy, Opioid-Free, Ketorolac, Dexmedetomidine, Acute postoperative pain relief, Opioid, Morphine, Fentanyl
Eligibility Criteria
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
Sites / Locations
- The Children's Hospital of PhiladelphiaRecruiting
- University of Tennessee Health Science Center; St. Jude Children's Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Traditional Care Group (TCG)
Opioid-Free Group (OFG)
Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding.
Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac.