Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06576830
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 21, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Jun 1, 2029

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Short acting opioids: Fentanyl/Hydromorphone
    Per Routine Care
  • Active Comparator: Long acting opioid: Methadone
    Initial Dosing: 0.15 mg/kg age-ideal body weight in children age 3 - \< 12 years and 0.2 mg/kg age-ideal body weight in adolescents age 12 - 17 years. Dose escalation (possible, based on interim analysis): 0.2 mg/kg age-ideal body weight in children age 3 - \< 12 years and 0.25 mg/kg age-ideal body weight in adolescents age 12 - 17 years.

Primary Outcome Measure

Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit) [ Time Frame: Up to 6 hours post surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Lisa Einhorn
[email protected]
Lisa M. Einhorn, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Duke University Medical Center· Durham, NC

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