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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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 106 participants.

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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.

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

FieldValue
Enrollment Target 106 participants
Start Date 2015-03-15
Est. Completion 2016-06-30
Phase Phase 4

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT02222246

The ClinicalTrials.gov registry entry for NCT02222246 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Hydromorphone (Standardized, weight-based dosing) is the first listed.

NCT02222246 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.