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Metabolomic Profiling of Racial Disparity
NCT06266429 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Blood collection
Study Locations (1)
Ohio
- Nationwide Children's Hospital — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2024-03-12 |
| Est. Completion | 2026-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06266429
The ClinicalTrials.gov registry entry for NCT06266429 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 239 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Surgery appearing as the primary indexed condition, and to 1 intervention — of which Blood collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06266429 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06266429 about?
NCT06266429 is a clinical study titled "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 pro...
What is the current status of trial NCT06266429?
This trial is currently active not recruiting. The enrollment target is 84 participants. The study started on 2024-03-12. Estimated completion is 2026-12-31.
What conditions does trial NCT06266429 study?
This clinical trial studies the following conditions: Surgery, Tonsillar Hypertrophy, Adenoid Hypertrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06266429?
The interventions under investigation include: Blood collection (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06266429?
This trial is sponsored by Nationwide Children's Hospital, which has 239 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06266429 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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