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NCT01482091 · ClinicalTrials.gov registry record · Phase 4
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
A Phase 4 study of Pain and Anemia, Sickle Cell, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 124
- Enrollment target
- 1
- Study location
NCT01482091: Completed Phase 4 study of Pain and Anemia, Sickle Cell, sponsored by Montefiore Medical Center.
NCT01482091 is a Phase 4 study of Pain and Anemia, Sickle Cell that has completed, run by Montefiore Medical Center. The registered enrollment target is 124 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01482091, a Phase 4 study of Pain and Anemia, Sickle Cell, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 124 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.
Primary Outcome
Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively. To calculate the change, the reported pain score at 20 minutes was subtracted f
Conditions Studied
Interventions
- DRUG Normal Saline
- DRUG Fentanyl Citrate
Study Locations (1)
New York
- Children's Hospital at Montefiore - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2011-12 |
| Phase | Phase 4 |
What the finished NCT01482091 record still lists
NCT01482091 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Normal Saline is the first listed.
NCT01482091 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01482091 about?
NCT01482091 is a clinical study titled "Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis". The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.
What is the current status of trial NCT01482091?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 124 participants. The study started on 2011-12.
What conditions does trial NCT01482091 study?
This clinical trial studies the following conditions: Pain, Anemia, Sickle Cell.
What interventions are being tested in trial NCT01482091?
The interventions under investigation include: Normal Saline (DRUG), Fentanyl Citrate (DRUG).
Who is sponsoring clinical trial NCT01482091?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01482091 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
Similar trials for Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01482091's enrollment target sits among peer trials
124 133rd of 374 higher than 242 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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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