Opioid-Free Anesthetic for Tonsillectomy

Children's Hospital of Philadelphia (CHOP)

Status and phase: Terminated; Phase 4

Conditions: Surgery; Sleep Disorder; Opioid Use; Tonsillitis; Anesthesia

Treatments: Drug: Fentanyl; Drug: Dexmedetomidine; Drug: Morphine; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT04528173

19-016618

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males or females age 2 to 18 years.
2. American Society of Anesthesiologists {ASA) ≤ 3 physical classification system
3. Girls after menarche must have a negative pregnancy test.
4. 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.
5. Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion criteria

1. Current (Within the last 30 days) opioid use for pain control
2. High risk for surgical site hemorrhage, determined by bleeding disorder diagnosis or evidence or poor hemostasis
3. Multiple scheduled surgeries at the same time other than adenoidectomy and/or ear tube placement
4. History of drug abuse, chronic pain, bleeding disorder
5. Chronic disease such as sickle cell disease for which treatment with opioids may be clinically indicated
6. 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.
7. History of hepatic dysfunction, renal dysfunction, thrombocytopenia, or anemia (including pre-surgery laboratory abnormalities)
8. History of hypersensitivity to NSAIDs
9. 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.)
10. Subjects receiving medications that could impact metabolism of either study drug should also be excluded
11. Trisomy 21 diagnosis
12. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
13. Patients on a Ketogenic diet
14. Parents or subjects who do not speak English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

35 participants in 2 patient groups

Traditional Care Group (TCG)

Active Comparator group

Description:

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.

Treatment:

Drug: Morphine

Drug: Fentanyl

Opioid-Free Group (OFG)

Experimental group

Description:

Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac.

Treatment:

Drug: Ketorolac

Drug: Dexmedetomidine