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Teen surgery opioid study seeks to predict addiction risk

NCT ID NCT06350409

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study follows 20,000 adolescents aged 12-17 who receive opioids after major surgery. Researchers track pain, opioid use, and other factors for one year to identify early warning signs of opioid use disorder. Participants complete surveys and allow access to their medical records, but no experimental treatment is given.

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 20,000 people

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

Started

Nov 2024

Expected to finish

Feb 2028

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

This study aims to recruit a convenience sample of approximately 10,000 dyads of adolescent (12-17 years, inclusive) patients and one parent (Total N=20,000). Adolescent participants will be undergoing scheduled surgeries with a greater than 90% likelihood of requiring opioid analgesia for at least 48 hours post-operatively (as an inpatient) or discharged home with at least a 48-hour supply of prescription opioids. Opioid prescribing practices vary by institution; therefore, eligible surgical procedures will be determined on a site-by-site basis. Exemplar surgeries at BCH and CCHMC sites include spinal fusion surgery, Nuss procedure, and anterior cruciate ligament reconstruction. Both inpatient and outpatient surgical procedures will be considered. All adolescent participants will be aged 12-17 at the time of enrollment and are children as defined by the NIH Policy on I

Ages

12 to 17 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.

Adolescent Inclusion Criteria 1. Adolescents between the ages of 12 to 17 years old, inclusive, who are scheduled to undergo a scheduled surgical procedure with a greater than 90% likelihood of requiring opioid analgesia for at least 48 hours post-operatively (as an inpatient) or discharged home with at least a 48-hour supply of prescription opioids. • Opioid prescribing practices vary by institution; therefore, eligible surgical procedures will be determined on a site-by-site basis. 2. Adolescents willing and able to provide informed assent and have a parent/caregiver willing to provide informed consent. Parent/Caregiver Inclusion Criteria 1. Parent or legal guardian of an eligible adolescent. 2. Parent or legal guardian willing and able to provide written informed consent. Adolescent Exclusion Criteria Adolescents meeting any of the following criteria will be excluded from study participation: 1. Adolescents who have been prescribed opioids in the past 2 years for pain due to a chronic medical condition. 2. Adolescents who have a current chronic medical condition that requires ongoing opioid pain management and treatment such as sickle cell disease, arthritis, or cancer. 3. Adolescents who do not have a caregiver who is willing to co-participate in the study. 4. Adolescents who cannot speak or read English at a 4th-grade level as determined by medical or research staff. 5. Adolescents who are currently in the custody of the Department of Youth Services, jail/prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities. 6. Adolescents who are currently in the custody of the Department of Children and Families or living with a foster family. 7. Adolescents who are currently pregnant or parenting. 8. Adolescents that self or parent report of ever having been diagnosed with opioid use disorder, or prescribed buprenorphine, methadone, or naltrexone to treat opioid use disorder. 9. Adolescents who are currently enrolled in an intervention study that aims to impact opioid prescription or pain management pre-, peri-, or post-operatively. Parent/Caregiver Exclusion Criteria Parents/Caregivers meeting any of the following criteria will be excluded from study participation: 1. Parents/Caregivers who cannot speak or read English or Spanish at a 4th grade level as determined by medical or research staff. 2. Parents/Caregivers that are currently incarcerated. 3. Parents/Caregivers that are in physical or mental distress that precludes study participation as determined by clinical or study staff.

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome opiate dependence Pain, Postoperative

As listed by the trial registrant

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

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

  • Boston Childrens Hopsital - Division of Addiction Medicine

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colorado

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital Medical Center

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Johns Hopkins All Children's Hospital

    NOT_YET_RECRUITING

    St. Petersburg, Florida, 33701, United States

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Other studies related to the condition(s) this trial covers.