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Opioid-Free Anesthetic for Tonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528173
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : September 1, 2021
Sponsor:
Collaborators:
University of Pennsylvania
University of Tennessee Health Science Center
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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Brief Summary:
Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic

Condition or disease Intervention/treatment Phase
Anesthesia Opioid Use Tonsillitis Sleep Disorder Surgery Drug: Ketorolac Drug: Dexmedetomidine Drug: Morphine Drug: Fentanyl Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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).
Primary Purpose: Treatment
Official Title: Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy
Actual Study Start Date : July 22, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Traditional Care Group (TCG)
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
Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.

Drug: Fentanyl
Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.
Experimental: Opioid-Free Group (OFG)
Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac.
 Drug: Ketorolac
Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.
Other Name: Toradol

Drug: Dexmedetomidine
Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Other Name: Precedex


Outcome Measures
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Primary Outcome Measures :
  1. Median Maximum Pain Score [ Time Frame: up to 30 minutes ]
    Median Maximum Pain Score by investigational group in the recovery room, calculated by the blinded observer 15 and 30 minutes after awakening.


Secondary Outcome Measures :
  1. Frequency of nausea, vomiting, pruritis [ Time Frame: up to post-op day 30 ]
    Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30.

  2. Frequency of readmission and of seeking unplanned medical attention (phone calls, office visits, ED visits) [ Time Frame: up to 2 years ]
    Chart review and questionnaires for readmission and medical reattendance, including calls to physician

  3. Frequency of non-artifactual percentage of oxygen saturation (SpO2)<90% (>30 seconds) [ Time Frame: up to 2 years ]
    Collected in recovery room and chart review

  4. Percentage of patients receiving rescue opioids [ Time Frame: up to 2 years ]
    Questionnaires and chart review

  5. Family satisfaction with patient recovery based on seven-point Likert score [ Time Frame: up to post-op day 30 ]
    Follow-up questionnaire to family on post-op days 1, 5, and 30. Parents will be asked to rank how satisfied they are with their child's recovery by using these two prompts: "I am satisfied with my child's recovery," and "I am satisfied with my child's pain control at home." They will choose from the following options: "Strongly agree = 1", "Agree = 2", "More or Less agree = 3", "Undecided = 4", "More or Less disagree = 5", "Disagree = 6", "Strongly Disagree =7." Minimum score is 1, Max is 7. Higher scores indicate worse outcomes.

  6. Bleeding prevalence [ Time Frame: up to 2 years ]
    Follow-up questionnaires and chart review


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528173


Contacts
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Contact: Tori N Sutherland, MD,MPH 267-426-2961 sutherlant@chop.edu
Contact: Paula Hu, MSPH (267) 426-0897 hup@chop.edu

Locations
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United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tori N Sutherland, MD, MPH    443-631-5032    sutherlant@chop.edu   
Contact: Paula Hu, RN, MSPH    267-225-3214    hup@chop.edu   
United States, Tennessee
University of Tennessee Health Science Center; St. Jude Children's Research Hospital Not yet recruiting
Memphis, Tennessee, United States, 38105
Contact: Anthony Sheyn, MD    901-287-7337    asheyn@uthsc.edu   
Contact: Madhu Mamidala, PHD    9014482134    mmamidal@uthsc.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
University of Tennessee Health Science Center
Investigators
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Principal Investigator: Tori Sutherland, MD,MPH Children's Hospital of Philadelphia
Principal Investigator: Anthony Sheyn, MD, FACS University of Tennessee Health Science Center
  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:
Study Protocol and Statistical Analysis Plan  [PDF] May 25, 2021
Informed Consent Form  [PDF] August 4, 2021

More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04528173    
Other Study ID Numbers: 19-016618
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Children's Hospital of Philadelphia:
Tonsillectomy
Opioid-Free
Ketorolac
Dexmedetomidine
 Acute postoperative pain relief
Opioid
Morphine
Fentanyl
Additional relevant MeSH terms:
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Tonsillitis
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Pharyngitis
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ketorolac
Fentanyl
Dexmedetomidine
 Morphine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid