Evidence map›Paper›PMID 42312422›Full record

Trial reportPaediatric anaesthesia2026

A Triple-Blinded, Randomized, Controlled Trial Comparing Hydromorphone vs. Fentanyl for Children Undergoing Tonsillectomy.

Gregory C Miller, Alan J Hifko, Julia K Lieu, Joseph T Nguyen, Judith E C Lieu, Michael C Montana

Registry-linked trialAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Paediatric anaesthesia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04230681 (A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04230681 early_phase1completednot on this map

A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

TypeinterventionalSponsorWashington University School of MedicineRan2020 to 2022Enrolled189ConditionsObstructive Sleep Apnea, TonsillitisArmsHydromorphone, Fentanyl
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Gregory C MillerDivision of Pediatric Anesthesiology, Department of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, USA.ORCID https://orcid.org/0000-0002-0164-0021
Alan J HifkoDepartment of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, USA.
Julia K LieuDepartment of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, USA.
Joseph T NguyenBetaNido, Pittsburgh, Pennsylvania, USA.
Judith E C LieuDivision of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.
Michael C MontanaDivision of Pediatric Anesthesiology, Department of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, USA.

Funding

WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
NCATS NIH HHS UL1 TR002345
6 · The paper itself

Abstract

backgroundTonsillectomy is one of the most frequently performed pediatric surgeries; however, little evidence guides the choice of intraoperative opioids in a population at an elevated risk for perioperative respiratory complications. This study tested the hypothesis that fewer children who received hydromorphone during tonsillectomy would require postoperative "rescue" opioids compared to children who received fentanyl.

methodsWe conducted a triple-blind, randomized, controlled trial to compare intravenous hydromorphone versus fentanyl in pediatric patients undergoing tonsillectomy. Children aged 2-15 years undergoing bilateral tonsillectomy or adenotonsillectomy were assigned (1:1) to receive hydromorphone (10 mcg/kg) or fentanyl (1 mcg/kg) intraoperatively. The primary endpoint was the number of patients who required rescue intravenous opioid analgesia following endotracheal extubation. Secondary endpoints included pain scores, pulse oximetry saturations, postoperative nausea, time in the recovery room, morphine milligram equivalents in the post-anesthesia care unit, and adverse events.

resultsA total of 188 children underwent randomization, and 180 were analyzed (90 in each group). The median age was 5 years (interquartile range: 3-7 years). Rescue intravenous opioid was administered to 48 (53%) children who received intraoperative hydromorphone and 66 (73%) children who received intraoperative fentanyl (difference, 20.0 percentage points; 95% confidence interval, 6.2-33.8) (p = 0.005). Children who received hydromorphone also had lower mean pain scores for the first 15 min postoperatively and lower median morphine milligram equivalents. The incidence of adverse events was similar between the two groups.

conclusionsThis study in children undergoing tonsillectomy found that intraoperative hydromorphone resulted in improved analgesia in the recovery room compared to fentanyl.

trial registrationClinicalTrials.gov: NCT04230681.

Indexed as

Analgesics, OpioidFentanylHydromorphonePostoperative PainTonsillectomyAdolescentChildChild, PreschoolFemaleHumansMalePain MeasurementPediatric AnesthesiaAnalgesics, OpioidFentanylHydromorphonefentanylhydromorphoneopioid analgesicspediatric anesthesiapostoperative paintonsillectomy

Identifiers

PMID42312422
PMCPMC13551164

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.