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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 is a Phase 2 study that was terminated before completion, run by Connecticut Children's Medical Center. The registered enrollment target is 3 participants.
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.
Interventions
- DRUG ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-03-04 |
| Est. Completion | 2010-02-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00595530
The ClinicalTrials.gov registry entry for NCT00595530 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Connecticut Children's Medical Center, which has 55 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ketamine is the first listed.
NCT00595530 reports 0 study locations.
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.
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