TerminatedPhase 4

A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

Stopped: Study participant had a related adverse event that prompted interim data analysis and additional study participants were not sought.

United States31 participantsStarted 2023-03-23

Plain-language summary

The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.

Who can participate

Age range

10 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Undergoing spinal surgery with a posterior approach for idiopathic scoliosis. Exclusion criteria: * Patients with pre-surgical elevated pain scores (≥ 3/10 on Numeric Rating Scale (NRS)), history of chronic pain, or pre-surgical opioid use will not be included. * Patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included. * Patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Intensity (Area Under the Curve Pain)

Timeframe: 18 hours after intrathecal hydromorphone administration

Trial details

NCT IDNCT05552443

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-27

Results submitted2026-01-20

View on ClinicalTrials.gov More Pain Control trials

Who can participate

Age range

10 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.