Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266429
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-04
First Post:
2021-02-24
Brief Title:
Metabolomic Profiling of Racial Disparity
Sponsor:
Olubukola Nafiu
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Metabolomic Profiling of Racial Disparity in Pediatric Post-tonsillectomy Pain
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tonsillectomy adenoidectomy TA is one of the most common surgical operations with over 500000 pediatric TAs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None