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NCT05552443 · ClinicalTrials.gov registry record · Phase 4
A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair
A Phase 4 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT05552443: Clinical Trial Phase 4 study, sponsored by Mayo Clinic.
NCT05552443 is a Phase 4 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05552443, a Phase 4 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study 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.
Primary Outcome
Pain intensity reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with 0=no pain and 10=worst pain ever. Subjects were asked to rate their pain approximately 9 different times within the first 18 hours after intrathecal hydromorphone administration. The sum of the patients' pain scores was calculated to determine pain intensity. Total scores ranging from 0 to 90 with higher scores indicating mo
Interventions
- DRUG Hydromorphone 2.5 mcg/kg
- DRUG Hydromorphone 2.75 mcg/kg
- DRUG Hydromorphone 3 mcg/kg
- DRUG Hydromorphone 3.25 mcg/kg
- DRUG Hydromorphone 3.5 mcg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 4 |
Why NCT05552443 stopped before completion
NCT05552443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which Hydromorphone 2.5 mcg/kg is the first listed.
NCT05552443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05552443 about?
NCT05552443 is a clinical study titled "A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair". 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.
What is the current status of trial NCT05552443?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2023-03-23. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT05552443?
The interventions under investigation include: Hydromorphone 2.5 mcg/kg (DRUG), Hydromorphone 2.75 mcg/kg (DRUG), Hydromorphone 3 mcg/kg (DRUG), Hydromorphone 3.25 mcg/kg (DRUG), Hydromorphone 3.5 mcg/kg (DRUG).
Who is sponsoring clinical trial NCT05552443?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05552443's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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