Opioid-Free Anesthetic for Tonsillectomy

NCT04528173 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 19-016618
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Anesthesia; Opioid Use; Tonsillitis; Sleep Disorder; Surgery

Keywords

Tonsillectomy; Opioid-Free; Ketorolac; Dexmedetomidine; Acute postoperative pain relief; Opioid; Morphine; Fentanyl

Outcome Measures

Primary Outcomes (1)

• Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score

  Mean FLACC pain assessment scores are calculated 15 and 30 minutes after awakening, Scores are calculated by a blinded study team observer. Minimum Score: 0 and Maximum Score: 10. Higher scores indicate worse outcomes. One Nursing Maximum FLACC pain score is obtained by an unblinded patient Registered Nurse (RN) during the patient's Post-Anesthesia Care Unit (PACU) stay within one hour of awakening. The pain score is collected from the nursing documentation in the electronic medical record. FLACC Minimum Score: 0 and Maximum Score: 10 Higher scores indicate worse outcomes.

  up to 1 hour

Secondary Outcomes (7)

• Number of Participants With Nausea, Vomiting, Pruritis

  up to post-op day 30

• Number of Participants Who Sought Unplanned Medical Attention

  up to post-op day 30

• Number of Participants Who Were Readmitted to the the Hospital

  Up to post-op day 30

• Number of Participants With Non-artefactual Percentage of Oxygen Saturation (SpO2)<90% (>30 Seconds)

  up to post-op day 30

• Number of Patients Receiving Rescue Opioids

  up to post-op day 30

Study Arms (2)

Traditional Care Group (TCG)

ACTIVE COMPARATOR

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.

Drug: Morphine; Drug: Fentanyl

Opioid-Free Group (OFG)

EXPERIMENTAL

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

Drug: Ketorolac; Drug: Dexmedetomidine

Interventions

Ketorolac DRUG

Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.

Also known as: Toradol

Opioid-Free Group (OFG)

Dexmedetomidine DRUG

Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.

Also known as: Precedex

Opioid-Free Group (OFG)

Morphine DRUG

Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.

Traditional Care Group (TCG)

Fentanyl DRUG

Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.

Traditional Care Group (TCG)

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator
• University of Tennessee: collaborator

Study Sites (2)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Tennessee Health Science Center; St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (34)

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Related Links

• Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17-5044). Center f
• Sealed Envelope Ltd. 2012. Power calculator for continuous outcome non-inferiority trial.
• Buck, ML. Use of Intravenous Ketorolac for Postoperative Analgesia in Infants: Pediatric Pharmacotherapy, A Monthly Newsletter. . 2011

MeSH Terms

Conditions

Tonsillitis; Sleep Wake Disorders

Interventions

Ketorolac; Ketorolac Tromethamine; Dexmedetomidine; Morphine; Fentanyl

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Tori Nicole Sutherland MD MPH
• Organization: The Children's Hospital of Philadelphia

sutherlant@chop.edu

443-631-5032

Study Officials

• Tori Sutherland, MD,MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Anthony Sheyn, MD, FACS

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The unblinded members are the treating anesthesiologist for the case, staff who randomize, and collect and enter intra-op medications into electronic data capture (EDC). Blinded members include the subject/family members, the surgeon, staff who perform post-op assessment, physician investigator who perform any adverse event/serious adverse event (AE/SAE) assessments, statistician and data safety monitoring board (DSMB).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group.

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 27, 2020
• Study Start: July 22, 2020
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-12

Locations

US (2)