RECRUITING

Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

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Conditions

Pain, PostoperativeTonsillar HypertrophyTonsillitisPediatric Sleep ApneaSleep-Disordered BreathingMethadoneTonsillectomyOpioid

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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

The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery in children and adolescents.

Official Title

Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double Blind Clinical Trial

Quick Facts

Study Start:2024-11-21
Study Completion:2029-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06576830

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:3 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>= 3 and \< 18 years
  2. 2. Elective tonsillectomy +/- adenoidectomy
  3. 3. Signed informed consent by parent or legal guardian
  4. 4. Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent
  5. 5. Negative pregnancy test within 48 hours for post pubescent females
  1. 1. History of chronic kidney or liver disease
  2. 2. Current diagnosis of a chronic pain disorder
  3. 3. Severe sleep apnea: Apnea Hypopnea Index \> 10
  4. 4. Planned admission to the Pediatric Intensive Care Unit (PICU)
  5. 5. Additional procedures under general anesthesia for which opioids would be prescribed

Contacts and Locations

Study Contact

Lisa M Einhorn, MD
CONTACT
9196814877
lisa.einhorn@duke.edu

Principal Investigator

Lisa M. Einhorn, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Lisa M. Einhorn, MD, PRINCIPAL_INVESTIGATOR, Duke University

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 Date2024-11-21
Study Completion Date2029-09-30

Study Record Updates

Study Start Date2024-11-21
Study Completion Date2029-09-30

Terms related to this study

Keywords Provided by Researchers

  • Methadone
  • Tonsillectomy
  • Opioid

Additional Relevant MeSH Terms

  • Pain, Postoperative
  • Tonsillar Hypertrophy
  • Tonsillitis
  • Pediatric Sleep Apnea
  • Sleep-Disordered Breathing