Metabolomic Profiling of Racial Disparity

Surgery Clinical Trial

Official title:

Metabolomic Profiling of Racial Disparity in Pediatric Post-tonsillectomy Pain

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06266429
• Other study ID #: STUDY00001304
• Status: Enrolling by invitation
• Start date: March 12, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adenoid Hypertrophy
• Hypertrophy
• Surgery
• Tonsillar Hypertrophy

Intervention

Diagnostic Test:
• Blood collection
Collecting blood pre-op and post-op for metabolite levels.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Olubukola Nafiu

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean fold-change of metabolomics markers by race using untargeted reverse-phase liquid-chromatographic mass spectrometry	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.	Immediately prior to surgery start and immediately post-op
Primary	Highest pain score	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.	Immediately after waking up from surgery
Primary	Last pain score	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.	Immediately prior to discharge