# Revolutionizing Pediatric Tonsillectomy Pharmacology and Therapeutics

> **NIH NIH R01** · DUKE UNIVERSITY · 2024 · $398,467

## Abstract

PROJECT SUMMARY/ABSTRACT
Safe and effective analgesia after surgery is a paramount yet unmet medical need in children, and poorly treated
pediatric pain remains a persistent and significant public health concern. For moderate to severe acute
postoperative pain, opioids remain the mainstay and most efficacious systemic pharmacologic therapy. However,
adequate age-specific pediatric pain treatment is limited by insufficient understanding of the dose-dependent
clinical effects of even widely available opioid analgesics. Every day, anesthesiologists and surgeons who care
for children are forced to navigate these knowledge gaps – to ensure adequate pain relief while balancing
concerns for opioid side effects and harms, patient and parental satisfaction, adherence to practice guidelines,
and compliance with legislative statutes that restrict opioid prescribing. The challenge to determine the optimal
analgesic regimen after pediatric surgery is particularly critical for the 500,000 children who undergo
tonsillectomy annually. Tonsillectomy is the most common painful elective procedure in children, yet analgesic
management after surgery remains inadequate, insufficient, and without consensus. Specifically, opioid
prescribing practices after tonsillectomy are highly variable, largely dependent on individual surgeons, and
susceptible to both over- and under-prescribing in an era when opioids have become a major public health
concern. We must do better. A recent paradigm shift in perioperative opioid use in adult surgical patients – the
use of long-acting (methadone) over short-acting opioids – has successfully diminished acute and chronic
postoperative pain and enabled less post-discharge opioid prescribing. Methadone, and its superior
pharmacologic properties, fulfills the therapeutic goal to better match the duration of analgesia to duration of
pain. Nonetheless, despite well-established benefits as a highly effective perioperative analgesic in adults,
methadone use to treat surgical pain in children has been limited to major inpatient procedures and hampered
by the lack of robust clinical data. Our proposal will address the urgent need to determine the optimal age-
specific, weight-based dose of intraoperative methadone for outpatient tonsillectomy in children in order to
improve analgesic outcomes and decrease the need for postoperative take-home opioids. We propose a single
center, randomized, double-blind, parallel-group, dose-finding trial of single-dose intraoperative intravenous (IV)
methadone compared with short-acting opioids in 396 children in three age-matched cohorts. We will 1)
determine the optimal age-specific intraoperative dose of IV methadone in pediatric tonsillectomy that results in
less postoperative pain and opioid use compared with short-acting opioids, and 2) assess the impact of long-
versus short-acting intraoperative opioid on post-tonsillectomy recovery outcomes. After study completion, we
expect to have enriched the understan...

## Key facts

- **NIH application ID:** 10855932
- **Project number:** 1R01HD114678-01
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** LISA M. EINHORN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $398,467
- **Award type:** 1
- **Project period:** 2024-09-03 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10855932

## Citation

> US National Institutes of Health, RePORTER application 10855932, Revolutionizing Pediatric Tonsillectomy Pharmacology and Therapeutics (1R01HD114678-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10855932. Licensed CC0.

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