Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease

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.

Conditions

• Sickle Cell Disease

Interventions

DRUG

Hydromorphone (Standardized, weight-based dosing)

Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).

DRUG

Morphine Sulfate (Standardized, weight-based dosing)

Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).

DRUG

Hydromorphone (Patient Specific dosing)

Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.

DRUG

Morphine Sulfate (Patient Specific dosing)

Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Cincinnati

  collaborator OTHER

• Mount Sinai Hospital, New York

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Paula Tanabe, PhD · Duke University School of Nursing

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-15

Primary Completion

2016-05-31

Completion

2016-06-30

Countries

• United States

Study Locations