Clinical trial NCT06266429: Metabolomic Profiling of Racial Disparity
Official title: Metabolomic Profiling of Racial Disparity in Pediatric Post-tonsillectomy Pain
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Adenoid Hypertrophy
Tonsillar Hypertrophy
Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing tonsillectomy ± adenoidectomy at Nationwide Children's Hospital.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mean fold-change of metabolomics markers by race using untargeted reverse-phase liquid-chromatographic mass spectrometry
timeFrame: Immediately prior to surgery start and immediately post-op
measure: Highest pain score
timeFrame: Immediately after waking up from surgery
measure: Last pain score
timeFrame: Immediately prior to discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References: