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Opioid-Free Anesthetic for Tonsillectomy

Primary Purpose

Anesthesia, Opioid Use, Tonsillitis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Dexmedetomidine
Morphine
Fentanyl
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Tonsillectomy, Opioid-Free, Ketorolac, Dexmedetomidine, Acute postoperative pain relief, Opioid, Morphine, Fentanyl

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • The Children's Hospital of PhiladelphiaRecruiting
  • University of Tennessee Health Science Center; St. Jude Children's Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Care Group (TCG)

Opioid-Free Group (OFG)

Arm 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.

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

Outcomes

Primary Outcome Measures

Median Maximum Pain Score
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

Frequency of nausea, vomiting, pruritis
Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30.
Frequency of readmission and of seeking unplanned medical attention (phone calls, office visits, ED visits)
Chart review and questionnaires for readmission and medical reattendance, including calls to physician
Frequency of non-artifactual percentage of oxygen saturation (SpO2)<90% (>30 seconds)
Collected in recovery room and chart review
Percentage of patients receiving rescue opioids
Questionnaires and chart review
Family satisfaction with patient recovery based on seven-point Likert score
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.
Bleeding prevalence
Follow-up questionnaires and chart review

Full Information

First Posted
July 28, 2020
Last Updated
August 1, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT04528173
Brief Title
Opioid-Free Anesthetic for Tonsillectomy
Official Title
Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, University of Tennessee

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Opioid Use, Tonsillitis, Sleep Disorder, Surgery
Keywords
Tonsillectomy, Opioid-Free, Ketorolac, Dexmedetomidine, Acute postoperative pain relief, Opioid, Morphine, Fentanyl

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group.
Masking
ParticipantInvestigatorOutcomes 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).
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Care Group (TCG)
Arm Type
Active Comparator
Arm 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.
Arm Title
Opioid-Free Group (OFG)
Arm Type
Experimental
Arm Description
Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.
Primary Outcome Measure Information:
Title
Median Maximum Pain Score
Description
Median Maximum Pain Score by investigational group in the recovery room, calculated by the blinded observer 15 and 30 minutes after awakening.
Time Frame
up to 30 minutes
Secondary Outcome Measure Information:
Title
Frequency of nausea, vomiting, pruritis
Description
Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30.
Time Frame
up to post-op day 30
Title
Frequency of readmission and of seeking unplanned medical attention (phone calls, office visits, ED visits)
Description
Chart review and questionnaires for readmission and medical reattendance, including calls to physician
Time Frame
up to 2 years
Title
Frequency of non-artifactual percentage of oxygen saturation (SpO2)<90% (>30 seconds)
Description
Collected in recovery room and chart review
Time Frame
up to 2 years
Title
Percentage of patients receiving rescue opioids
Description
Questionnaires and chart review
Time Frame
up to 2 years
Title
Family satisfaction with patient recovery based on seven-point Likert score
Description
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.
Time Frame
up to post-op day 30
Title
Bleeding prevalence
Description
Follow-up questionnaires and chart review
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tori N Sutherland, MD,MPH
Phone
267-426-2961
Email
sutherlant@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Hu, MSPH
Phone
(267) 426-0897
Email
hup@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tori Sutherland, MD,MPH
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony Sheyn, MD, FACS
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tori N Sutherland, MD, MPH
Phone
443-631-5032
Email
sutherlant@chop.edu
First Name & Middle Initial & Last Name & Degree
Paula Hu, RN, MSPH
Phone
267-225-3214
Email
hup@chop.edu
Facility Name
University of Tennessee Health Science Center; St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Sheyn, MD
Phone
901-287-7337
Email
asheyn@uthsc.edu
First Name & Middle Initial & Last Name & Degree
Madhu Mamidala, PHD
Phone
9014482134
Email
mmamidal@uthsc.edu

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Opioid-Free Anesthetic for Tonsillectomy

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