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NCT01891812 · ClinicalTrials.gov registry record · Phase 2
Nitrous Oxide Analgesia Vaso-occlusive Crisis
A Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT01891812: Completed Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by Columbia University.
NCT01891812 is a Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis that has completed, run by Columbia University. The registered enrollment target is 5 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01891812, a Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients who have sickle cell VOC are usually treated with opioids, such as morphine. However, this current way of treating them has not improved the health, medical outcomes, or rates of hospitalizations. In addition, since VOC can happen very frequently over a long period of time, giving opioids over and over again can cause both short-term and long-term problems. Nitrous oxide (N2O) is a way of treating pain that may provide a better alternative to repeatedly giving opioids over long periods of time. N2O has been shown to provide up to 3 hours of pain relief in inpatient patients with VOC whose pain did not improve with morphine infusions, and is used extensively in France, where almost half of 85 pediatric emergency departments use nitrous oxide to treat children with VOC whose pain did not get better with standard treatment with morphine. However, pain relief which N2O provides in the acute setting has not been well described. Therefore, the purpose of our study is to describe how well N2O can relieve the pain in patients with SCD who present to the emergency department and are experiencing a VOC.
Primary Outcome
Patient-reported pain score immediately after administration of nitrous oxide. The full range of the pain score is 0 to 10; 0 = no pain, 10 = worst pain.
Conditions Studied
Interventions
- DRUG Nitrous oxide 50%
Study Locations (1)
New York
- New York Presbyterian Morgan Stanley Children's Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-11-12 |
| Est. Completion | 2018-01-19 |
| Phase | Phase 2 |
What the finished NCT01891812 record still lists
NCT01891812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Nitrous oxide 50% is the first listed.
NCT01891812 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01891812 about?
NCT01891812 is a clinical study titled "Nitrous Oxide Analgesia Vaso-occlusive Crisis". Patients who have sickle cell VOC are usually treated with opioids, such as morphine. However, this current way of treating them has not improved the health, medical outcomes, or rates of hospitalizations. In addition, since VOC can happen very frequently over a long period of time, giving opioids o...
What is the current status of trial NCT01891812?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2013-11-12. Estimated completion is 2018-01-19.
What conditions does trial NCT01891812 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Vaso-occlusive Crisis.
What interventions are being tested in trial NCT01891812?
The interventions under investigation include: Nitrous oxide 50% (DRUG).
Who is sponsoring clinical trial NCT01891812?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01891812 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01891812's enrollment target sits among peer trials
5 208th of 213 higher than 5 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease 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.
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