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NCT02222246 · ClinicalTrials.gov registry record · Phase 4
Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 106
- Enrollment target
NCT02222246: Completed Phase 4 study, sponsored by Duke University.
NCT02222246 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 106 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02222246, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 106 participants
- Enrollment target
Study Summary
The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.
Primary Outcome
Each ED study visit was the unit of analysis for the statistical methods addressing the primary outcome. The primary outcome was change in pain score from arrival to discharge. Pain severity was assessed at arrival and discharge from ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating "no pain" and 100 indicating "pain as bad as it could be" or "worst imaginable pain".Discharge was defined by which one of the following occurred first: (a) decision to admit
Interventions
- DRUG Hydromorphone (Standardized, weight-based dosing)
- DRUG Morphine Sulfate (Standardized, weight-based dosing)
- DRUG Hydromorphone (Patient Specific dosing)
- DRUG Morphine Sulfate (Patient Specific dosing)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2015-03-15 |
| Est. Completion | 2016-06-30 |
| Phase | Phase 4 |
What the finished NCT02222246 record still lists
NCT02222246 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Hydromorphone (Standardized, weight-based dosing) is the first listed.
NCT02222246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02222246 about?
NCT02222246 is a clinical study titled "Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease". The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with S...
What is the current status of trial NCT02222246?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 106 participants. The study started on 2015-03-15. Estimated completion is 2016-06-30.
What interventions are being tested in trial NCT02222246?
The interventions under investigation include: Hydromorphone (Standardized, weight-based dosing) (DRUG), Morphine Sulfate (Standardized, weight-based dosing) (DRUG), Hydromorphone (Patient Specific dosing) (DRUG), Morphine Sulfate (Patient Specific dosing) (DRUG).
Who is sponsoring clinical trial NCT02222246?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02222246's enrollment target sits among peer trials
106 747th of 2000 higher than 1,252 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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