Opioid-Free Anesthetic for Tonsillectomy

August 1, 2023 updated by: Children's Hospital of Philadelphia

Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

550

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Paula Hu, MSPH
  • Phone Number: (267) 426-0897
  • Email: hup@chop.edu

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • The Children's Hospital of Philadelphia
        • Contact:
        • Contact:
          • Paula Hu, RN, MSPH
          • Phone Number: 267-225-3214
          • Email: hup@chop.edu
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • University of Tennessee Health Science Center; St. Jude Children's Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Toradol
Drug: Dexmedetomidine
Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to post-op day 30
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
up to 2 years
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
up to 2 years
Percentage of patients receiving rescue opioids
Time Frame: up to 2 years
Questionnaires and chart review
up to 2 years
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.
up to post-op day 30
Bleeding prevalence
Time Frame: up to 2 years
Follow-up questionnaires and chart review
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania
University of Tennessee

Investigators

  • Principal Investigator: Tori Sutherland, MD,MPH, Children's Hospital of Philadelphia
  • Principal Investigator: Anthony Sheyn, MD, FACS, University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2020

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-016618

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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