Clinical trial NCT04528173: Opioid-Free Anesthetic for Tonsillectomy
Official title: Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthesia
Opioid Use
Tonsillitis
Sleep Disorder
Surgery
Keywords: Tonsillectomy
Opioid-Free
Ketorolac
Dexmedetomidine
Acute postoperative pain relief
Opioid
Morphine
Fentanyl
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Tennessee
First posted: 2020-08-27
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score
timeFrame: up to 1 hour
Secondary outcomes:
measure: Number of Participants With Nausea, Vomiting, Pruritis
timeFrame: up to post-op day 30
measure: Number of Participants Who Sought Unplanned Medical Attention
timeFrame: up to post-op day 30
measure: Number of Participants Who Were Readmitted to the the Hospital
timeFrame: Up to post-op day 30
measure: Number of Participants With Non-artefactual Percentage of Oxygen Saturation (SpO2)<90% (>30 Seconds)
timeFrame: up to post-op day 30
measure: Number of Patients Receiving Rescue Opioids
timeFrame: up to post-op day 30
measure: Family Satisfaction With Patient Recovery Based on Five-point Likert Score
timeFrame: assessed at post-op days 1, 5, and 30
measure: Number of Participants That Experienced Any Post-operative Bleeding Throughout the Study
timeFrame: up to post-op day 30
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Health Science Center; St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Tori Sutherland, MD,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Anthony Sheyn, MD, FACS
role: PRINCIPAL_INVESTIGATOR
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