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NCT00595530 · ClinicalTrials.gov registry record · Phase 2
Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain
A Phase 2 study, sponsored by Connecticut Children's Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00595530: Clinical Trial Phase 2 study, sponsored by Connecticut Children's Medical Center.
NCT00595530 is a Phase 2 study that was terminated before completion, run by Connecticut Children's Medical Center. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00595530, a Phase 2 study, was terminated before completion, sponsored by Connecticut Children's Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Acute pain episodes associated with sickle cell disease (SCD) are very difficult to manage effectively. Opioid tolerance and side effects have been major roadblocks in our ability to provide these patients with adequate pain relief. This pilot study is designed to examine the safety and feasibility of using ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, in the inpatient seeing with children and adolescents who have sickle cell vasoocclusive pain. Previous research suggests that in subanesthetic doses, ketamine may be able to prevent the development of opiate tolerance and facilitate better pain relief with lower opiate doses, allowing for less respiratory depression, less sedation, easier ambulation, less deconditioning, shorter hospital stays, and better quality of life. The goal of this pilot study is to evaluate the safety and feasibility of using a continuous infusion of ketamine, in conjunction with opiates, in the inpatient setting for sickle cell vasoocclusive pain. It is hypothesized that using a low dose ketamine infusion in conjunction with opiates will be a safe and feasible practice for the treatment of sickle cell pain.
Primary Outcome
Determine if there is an apparent improvement in pain control with the ketamine infusion based on the investigator's discretion and comparison to past pain scores. Pain was scored on a scale from 0 to 10. Zero equaled no pain and 10 equaled a lot of pain.
Interventions
- DRUG ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-03-04 |
| Est. Completion | 2010-02-12 |
| Phase | Phase 2 |
Why NCT00595530 stopped before completion
NCT00595530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which ketamine is the first listed.
NCT00595530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00595530 about?
NCT00595530 is a clinical study titled "Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain". Acute pain episodes associated with sickle cell disease (SCD) are very difficult to manage effectively. Opioid tolerance and side effects have been major roadblocks in our ability to provide these patients with adequate pain relief. This pilot study is designed to examine the safety and feasibility ...
What is the current status of trial NCT00595530?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2008-03-04. Estimated completion is 2010-02-12.
What interventions are being tested in trial NCT00595530?
The interventions under investigation include: ketamine (DRUG).
Who is sponsoring clinical trial NCT00595530?
This trial is sponsored by Connecticut Children's Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00595530's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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