Metabolomic Profiling of Racial Disparity

Tonsillectomy ± adenoidectomy (T&A) is one of the most common surgical operations with over 500,000 pediatric T&As performed annually in the United States. Unfortunately, despite advances in anesthetic and surgical techniques, moderate-severe post-tonsillectomy pain (PTP) remains a significant problem affecting up to 62% of children. PTP is thought to arise from pharyngeal mucosal inflammation, which produces local nerve irritation and pharyngeal muscle spasm. Patient factors and surgical techniques also play major roles. Race is an important phenotypic risk factor for moderately severe early PTP. The underlying molecular basis of this differential pain experience is presently unknown. This gap in knowledge means that therapies are poorly targeted and often unsuccessful. Indeed, treatment options for PTP have not advanced substantively for many years. Metabolomics provides novel opportunities to investigate common and unique "metabolic signature" of PTP through the analysis of low molecular weight compounds produced in response to tissue injury. Therefore, the central themes of this proposal are that (1) PTP is a complex process that may be determined by molecular level factors such as preoperative systemic inflammation and metabolic profile, and (2) these molecular level factors may explain the excess burden of PTP among minority children. Here the investigators seek to utilize a combined clinical, biological and untargeted metabolomics approach to identify candidate small and large serum molecules that may influence the frequency and severity of PTP in children across racial groups. This approach to exploring the molecular basis of PTP is novel and knowledge from the study should substantially enhance understanding of the mechanisms underlying pediatric PTP - and narrow the racial disparities in post-operative pain.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Adenoid Hypertrophy Surgery Tonsillar Hypertrophy

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Consenting (or assenting) patients age 4-17yr and American Society of Anesthesiologist's (ASA) physical status I-III who are scheduled for elective tonsillectomy ± adenoidectomy (T&A).

Exclusion criteria

Age > 18 years old
Children below 4 years of age because they are routinely admitted following T&A in our institution and may not be able to clearly self-report their pain
Children on chronic preoperative analgesic medications
Children with Cushing's syndrome, or nephrotic syndrome
Children on chronic systemic steroids
Children with concurrent surgical procedures that could prolong the duration of anesthesia and surgery
Children that do not speak English or cannot self-report their pain after surgery (significant cognitive impairment, anticipated or unplanned postoperative endotracheal intubation, and sedation)

Treatment and study plan

Blood collection

Diagnostic Test

Collecting blood pre-op and post-op for metabolite levels.

Primary outcomes

Mean fold-change of metabolomics markers by race using untargeted reverse-phase liquid-chromatographic mass spectrometry

Time frame: Immediately prior to surgery start and immediately post-op

The global evaluation of small molecule biomarkers, metabolites, and the relative levels of molecular and chemical markers of post-tonsillectomy pain severity. Mass spectrometry detection following separation of protein-precipitated plasma by a C18 column liquid chromatography will provide the relative abundances of small molecule lipids, drug metabolites, amino acids, sugars, and other small potential biomarkers in subjects and using quality-control pooled analysis all samples will be normalized so that each individual metabolite can be compared between high and low-pain samples. Those metabolites found to have significant fold changes between high and low-pain subjects can be further quantified with targeted metabolomics to get absolute quantitation in plasma.
Highest pain score

Time frame: Immediately after waking up from surgery

Highest recorded post-anesthesia care unit (PACU) pain score upon emerging from general anesthesia will be assessed with the Wong-Baker face scale. Scale is 0-10, with 0 being no pain and 10 being worst pain.
Last pain score

Time frame: Immediately prior to discharge

Last recorded pain score prior to discharge from the hospital will be assessed with the Wong-Baker face scale. Scale is 0-10, with 0 being no pain and 10 being worst pain.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Metabolomic Profiling of Racial Disparity in Pediatric Post-tonsillectomy Pain

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2026
First posted: Feb 20, 2024
Registry last updated: Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting