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Teens' genes may predict pain after back surgery

NCT ID NCT02998138

Knowledge-focused Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at how a child's genes and emotions influence pain after major spine surgery. Researchers will follow 880 teens aged 10-18 having spine fusion for scoliosis or similar conditions. They will measure pain levels, breathing problems, and nausea after surgery, and check for long-term pain. The goal is to understand why some kids have more pain than others, which could help doctors personalize pain treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to predict and manage pain in children after major surgery, potentially reducing opioid use.
What could go wrong
This is an observational study, not testing a treatment. It may not directly change patient care, and results might not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 880 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Dec 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The investigators will recruit a total of 200 subjects over the study period to acquire the data necessary to derive a predictive model matching phenotype to genotype. They will be recruited from the population of children ages 10 to 18, inclusive, years scheduled for spinal surgical procedures.

Ages

10 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Children aged 10 to 18, inclusive, years of age 2. Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis 3. Scheduled for spine fusion. Exclusion Criteria: 1. Patients on chronic pain medication (opioid use over 6 months prior to surgery) 2. Pregnant or breastfeeding females. 3. Children with a history of or active renal or liver disease. 4. Non-English speaking patients. 5. Developmental delay 6. Body Mass Index ≥ 30 7. Currently taking tricyclic, selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI) class of medications (within the last month) 8. Cardiac conditions including, but not limited to, cyanotic heart disease, Hypoplastic Left Ventricle, arrhythmia, hypertension with ongoing treatment, Kawasaki Disease, cardiomyopathies. Patients with asymptomatic valvular lesions or defects may be included. 9. Severe lung disease such as cystic fibrosis, pulmonary fibrosis, pneumonia within the last month 10. History of seizures currently treated on medication (patients off medication and seizure free for greater than one year may be included) 11. Other known genetic diseases including but not limited to Ehlers Danlos, Downs' etc. 12. History of Obstructive sleep apnea by history (pauses during sleep, significant snoring, use of CPAP)

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Conditions

The condition(s) this trial relates to.

Chronic Pain idiopathic scoliosis kyphoscoliosis 1 Kyphosis Pain, Postoperative scoliosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kyphoscoliosis Kyphosis Scoliosis

Contacts and locations

Locations

  • Duke Children's Hospital

    Durham, North Carolina, 27710, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205, United States

  • Stanford University Hospital

    Stanford, California, 94305, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

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