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Recruiting NCT06576830

Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Phase IV Interventional Pain, Postoperative Tonsillar Hypertrophy Tonsillitis Pediatric Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methadone, Fentanyl/Hydromorphone.
Who it may be relevant to
Registry conditions: Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis, Pediatric Sleep Apnea. Basic parameters: 3 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed description

This is a randomized, double-blind, parallel-group, dose-escalation investigation. Participants ("children" defined as ages 3 - \< 12 years and "adolescents" defined as ages 12 - 17 years) will be randomized 2:1 to either methadone or short-acting opioid. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. The trial will include 2 periods in 3 parallel age groups. In the first period, each age cohort will recruit 66 patients (44 methadone, 22 control). Children will be randomized to methadone 0.15 mg/kg age-ideal body weight and adolescents to 0.2 mg/kg age-ideal body weight. When an age cohort reaches 66 patients, this is the end of the first period. At that time, an unblinded interim analysis will be conducted in that cohort to determine if dose escalation to 0.2 mg/kg dose in children and the 0.25 mg/kg dose in adolescents are met. Methadone dose escalation will be based on clinically meaningful differences in need for rescue opioid in the PACU and the absence of well-defined opioid adverse events. Outcomes data will be collected in hospital and after discharge. With daily surveys for 7 days, and 3 phone calls on day 30, 3 months and 6 months after surgery.

Interventions

  • Drug Methadone
    Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.
  • Drug Fentanyl/Hydromorphone
    Per routine care, given as needed

Primary outcome measures

  • Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit) [Time frame: Up to 6 hours post surgery]
Secondary outcome measures (5)
  • Total amount of opioid medication administered [Time frame: Up to 7 days post surgery]
  • Opioid administration in the PACU (post-anesthesia care unit) [Time frame: Up to 6 hours post surgery]
  • Opioid administration post PACU (post-anesthesia care unit) [Time frame: Up to 7 days post surgery]
  • Evaluation of participant's pain as measured by Numeric Pain Rating Scale [Time frame: Up to 7 days post surgery]
  • Number of participants with adverse event in the PACU (post-anesthesia care unit) [Time frame: Up to 6 hours post surgery]

Eligibility criteria

Inclusion criteria

  • Age >= 3 and < 18 years
  • Elective tonsillectomy +/- adenoidectomy
  • Signed informed consent by parent or legal guardian
  • Children >= 12 years must provide signed written consent, Children >= 7 years must provide verbal assent
  • Negative pregnancy test within 48 hours for post pubescent females

Exclusion criteria

  • History of chronic kidney or liver disease
  • Current diagnosis of a chronic pain disorder
  • Planned admission to the Pediatric Intensive Care Unit (PICU)
  • Additional procedures under general anesthesia for which opioids would be prescribed

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Duke University Medical Center — Durham

Publications

  • Einhorn LM, Hoang J, La JO, Kharasch ED. Single-dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double-blind Clinical Trial. Anesthesiology. 2024 Sep 1;141(3):463-474. doi: 10.1097/ALN.0000000000005031. PMID 38669011

Identifiers

NCT: NCT06576830 · Pro00114677 · 1R01HD114678-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗