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NCT01851720 · ClinicalTrials.gov registry record · Phase 2
Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
A Phase 2 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT01851720: Clinical Trial Phase 2 study, sponsored by Johns Hopkins University.
NCT01851720 is a Phase 2 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01851720, a Phase 2 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache management is complex, requiring a balance between pain control and preservation of neurological assessment. Sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effects. Most critically, all narcotics can result in respiratory depression and sedation. For patients who present without neurological defects but debilitating pain, management is particularly challenging. The sedative effect of narcotics confounds the management of these patients by interfering with the neurological examination. Pain management is also a significant concern for patient's families as they observe suffering without full understanding of the importance of preserved mental status. In order to control the pain associated with SAH headaches, the use of narcotics is often required despite the risks. This standard therapy involves an IV bolus dose delivered by the provider regularly as needed for pain control. A common approach to reduce pain in other patient populations, including acute pain relief following major spine surgery, is patient controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that this approach to pain relief for SAH headaches will result in lower pain scores, greater patient and family satisfaction scores, and increased patient safety with lower narcotic doses minimally interfering with neurological assessment.
Interventions
- DRUG Low dose fentanyl PCA
- DRUG Standard IV fentanyl bolus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-09-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01851720
The ClinicalTrials.gov registry entry for NCT01851720 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low dose fentanyl PCA is the first listed.
NCT01851720 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01851720 about?
NCT01851720 is a clinical study titled "Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage". Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache management is complex, requiring a balance between pain control and preservation of neurological assessment. Sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effe...
What is the current status of trial NCT01851720?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2012-07. Estimated completion is 2014-09-15.
What interventions are being tested in trial NCT01851720?
The interventions under investigation include: Low dose fentanyl PCA (DRUG), Standard IV fentanyl bolus (DRUG).
Who is sponsoring clinical trial NCT01851720?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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