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NCT02492295 · ClinicalTrials.gov registry record · NA
Low-dose Propofol for the Treatment of Severe Refractory Migraine Headache in the Emergency Department
A NA study, sponsored by Albert Einstein Healthcare Network.
- Terminated
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT02492295 is a NA study that was terminated before completion, run by Albert Einstein Healthcare Network. The registered enrollment target is 12 participants.
The verdict
NCT02492295, a NA study, was terminated before completion, sponsored by Albert Einstein Healthcare Network.
- TERMINATED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Migraine headache is a frequent Emergency Department complaint. While first-line Emergency Department treatment for this condition is well-established, optimal second-line treatment options are not well-defined. First line Emergency Department treatments include Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), dopamine antagonists. Second line treatments that have been proposed include triptans, steroids, antiepileptics, benzodiazepines, magnesium and narcotics, but none have shown reliable Emergency Department efficacy (less than 50% in most studies). In the past ten years there have been several case series published on using low, sub-anesthetic doses of propofol for the treatment of refractory migraine. These case series have reported very impressive efficacy rates, especially in comparison to the published efficacy rates of other second-line treatments. Personal experience using this treatment modality has also yielded impressive clinical results. Most of the published series, however, have not been conducted in the Emergency Department. The Investigators propose to conduct a prospective, observational trial of low-dose propofol for the treatment of refractory migraine in the Emergency Department. Propofol is a frequently-used Emergency Department sedative, with a good safety profile when administered by experienced Emergency Medicine practitioners using appropriate monitoring. The primary outcome measurement will be reduction of pain after treatment, with secondary outcome measures related to the safety of treatment and continuation of pain relief after leaving the Emergency Department. Although the protocol will involve the use of low-dose propofol with the aim of achieving light-to-moderate sedation only, all patients will care for and monitor at a level appropriate for deep procedural sedation.
Interventions
- DRUG Propofol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-01-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02492295
The ClinicalTrials.gov registry entry for NCT02492295 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein Healthcare Network, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Propofol is the first listed.
NCT02492295 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02492295 about?
NCT02492295 is a clinical study titled "Low-dose Propofol for the Treatment of Severe Refractory Migraine Headache in the Emergency Department". Migraine headache is a frequent Emergency Department complaint. While first-line Emergency Department treatment for this condition is well-established, optimal second-line treatment options are not well-defined. First line Emergency Department treatments include Non-Steroidal Anti-Inflammatory Drugs...
What is the current status of trial NCT02492295?
This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2014-08. Estimated completion is 2016-01-01.
What interventions are being tested in trial NCT02492295?
The interventions under investigation include: Propofol (DRUG).
Who is sponsoring clinical trial NCT02492295?
This trial is sponsored by Albert Einstein Healthcare Network, which has 48 total clinical trials registered on ClinicalTrials.gov.
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