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Gene test may predict painkiller side effects in children

NCT ID NCT05367609

Knowledge-focused Sponsor: Senthil Sadhasivam Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study looks at whether a child's genes can predict how they will respond to painkillers after spine fusion surgery. Researchers will test 300 children aged 10 to 21 for specific gene variants linked to pain relief and side effects like nausea and breathing problems. The goal is to create a personalized pain management plan that reduces risks and improves recovery.

What this could mean

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

Active substance
genetic testing (CYP2D6, ABCB1, FAAH, OPRM1, COMT variants)
What this could lead to
If successful, this could lead to safer, more effective pain management for children after major surgery, reducing risks like breathing problems and nausea.
What could go wrong
This is an early-stage observational study, not a treatment trial. It may not find clear genetic links, and results may not change practice for years.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

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

Started

Sep 2022

Expected to finish

Oct 2027

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.

Ages

10 to 21 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: * Children ages 10 to 21 * ASA physical status 1 to 3 * Undergoing Posterior-Lateral Spinal Fusion * Receives in-patient opioids * Prescribed opioids at discharge Exclusion Criteria: * Serious illness * Preoperative severe pain * Preoperative opioid use or misuse

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Conditions

The condition(s) this trial relates to.

Polymerase proofreading-related adenomatous polyposis

As listed by the trial registrant

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

PPAP Spine fusion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Orthopaedic and Scoliosis Surgery Associates, LLP

    NOT_YET_RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Johns Hopkins All Children's Hospital

    NOT_YET_RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Riley Children's Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • UPMC Children's Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • University of California

    RECRUITING

    San Francisco, California, 38456, United States

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