Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Condition
Pain, Postoperative
Intervention / Treatment

-

Contacts and Locations

Durham

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

3 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Duke University,

Lisa M. Einhorn, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2029-09-30