TERMINATED

Opioid-Free Anesthetic for Tonsillectomy

Conditions

Anesthesia Opioid Use Tonsillitis Sleep Disorder Surgery Tonsillectomy Opioid-Free Ketorolac Dexmedetomidine Acute postoperative pain relief Opioid Morphine Fentanyl

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy

Quick Facts

Study Start:2020-07-22

Study Completion:2023-08-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04528173

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.

Ages Eligible for Study:2 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Principal Investigator

Tori Sutherland, MD,MPH

PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Anthony Sheyn, MD, FACS

PRINCIPAL_INVESTIGATOR

University of Tennessee

Study Locations (Sites)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

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

Memphis, Tennessee, 38105

United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Tori Sutherland, MD,MPH, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia
Anthony Sheyn, MD, FACS, PRINCIPAL_INVESTIGATOR, University of Tennessee

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 Registration Dates

Study Start Date2020-07-22

Study Completion Date2023-08-22

Study Record Updates

Study Start Date2020-07-22

Study Completion Date2023-08-22

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Anesthesia
Opioid Use
Tonsillitis
Sleep Disorder
Surgery