TerminatedPhase 4

A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

Stopped: Study participant #27 had a related adverse event that prompted interim data analysis and additional study participants were not sought.

United States27 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 range10 Years – 17 Years

SexALL

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.

What they're measuring

Pain intensity

Timeframe: 18 hours after intrathecal hydromorphone administration

Trial details

NCT IDNCT05552443

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-27

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