drugset / Trial / NCT05552443

A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair

NCT05552443

Phase 4 Terminated 31 enrolled Mayo Clinic
Non-randomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2023-03-23
Primary completion
2024-10-27
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 2.5 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 2.75 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 3 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 3.25 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 3.5 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 4 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 4.5 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 5 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 5.5 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 6 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 6.5 ug/kg Intrathecal
Subject Hydromorphone Other / unclassified 7 ug/kg Intrathecal

Indications

No indication recorded.