Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell; Acute Pain
Intervention: Hydromorphone (Standardized, weight-based dosing); Morphine Sulfate (Standardized, weight-based dosing); Hydromorphone (Patient Specific dosing); Morphine Sulfate (Patient Specific dosing)
Intervention description: Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).; Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).; Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.; Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Intervention MeSH terms: Morphine; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Sickle Cell Disease; Emergency Department; Vaso-occlusive Crisis; Pain Management; Pilot Project

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult SCD patients with genotypes SS, SC, SB+, or SB-

        Exclusion Criteria:

          -  Patients with sickle cell trait

          -  Allergic to both morphine sulfate and hydromorphone,

          -  Patients who have an explicit care plan that states they cannot be admitted to the
             hospital for pain control,

          -  Non-English speaking,

          -  Patients admitted for a medical complication,

          -  Record of >24 ED visits in the prior 12 months,

          -  Children