Adenoid HypertrophyNCT06266429
Metabolomic Profiling of Racial Disparity
An observational study of Adenoid Hypertrophy and Tonsillar Hypertrophy, run by Nationwide Children's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Adenoid Hypertrophy, Tonsillar Hypertrophy, Surgery
- What is being tested?
- Blood collection
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing tonsillectomy ± adenoidectomy at Nationwide Children's Hospital.
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Metabolomic Profiling of Racial Disparity in Pediatric Post-tonsillectomy Pain
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
- Adenoid Hypertrophy, Tonsillar Hypertrophy, Surgery
- Being tested
- Blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionDiagnostic test
Collecting blood pre-op and post-op for metabolite levels.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately prior to surgery start and immediately post-op
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.
Measured: Immediately after waking up from surgery
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.
Measured: Immediately prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start12 Mar 2024
- Primary completion22 Nov 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid HypertrophyStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266429
- Sponsor's protocol ID
- STUDY00001304
- Status last verified
- Oct 2025
- First submitted
- 24 Feb 2021
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Profiling of Racial Disparity in Pediatric Post-tonsillectomy Pain
- ClinicalTrials.gov ID
- NCT06266429
- Acronym / sponsor ID
- STUDY00001304
- Conditions
- Adenoid Hypertrophy, Tonsillar Hypertrophy, Surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing tonsillectomy ± adenoidectomy at Nationwide Children's Hospital.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionCollecting blood pre-op and post-op for metabolite levels. | Diagnostic test | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoid Hypertrophy and Tonsillar Hypertrophy, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.