Clinical trial NCT02222246: Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
Official title: Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
Conditions: 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.
Interventions:
description: Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
name: Hydromorphone (Standardized, weight-based dosing)
other_name: Dilaudid
type: Drug
description: Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
name: Morphine Sulfate (Standardized, weight-based dosing)
type: Drug
description: Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
name: Hydromorphone (Patient Specific dosing)
other_name: Dilaudid
type: Drug
description: Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
name: Morphine Sulfate (Patient Specific dosing)
type: Drug
Study arms:
design_group_description: A patient-specific analgesic protocol for use in the ED to manage VOC crises. Following randomization, a patient's healthcare team will develop a specific analgesic protocol for use during future ED visits for VOC occurring during the study period (up to 5 visits). Treatment protocols will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous). Dosage and frequency will be based on a patient's prior treatment history.
design_group_title: Patient Specific dose of Morphine Sulfate or Hydromorphone
design_group_type: Experimental
design_group_description: A standardized analgesic protocol (based on recent NHLBI recommendations) for use in the ED to manage VOC crises. Treatment protocol will include either morphine sulfate or hydromorphone (delivered intravenous or sub-cutaneous), with dosage based on weight. Repeat doses of opioids may be administered every 20-30 minutes as needed, although dosage will be maintained or provided at no more than 25% above the initial dose.
design_group_title: Standard dose of Morphine Sulfate or Hydromorphone
design_group_type: Active Comparator
Sponsor: Duke University
Collaborators: National Heart, Lung & Blood Institute
University of Cincinnati (Ohio)
The Mount Sinai Hospital
National Institutes of Health
Drug name mappings:
name: 盐酸氢吗啡酮
lang: CN
name: Hydromorphone Hydrochloride
lang: EN
name: ヒドロモルフォン塩酸塩
lang: JP
name: 硫酸吗啡
lang: CN
name: Morphine Sulfate
lang: EN
name: モルヒネ硫酸塩水和物
lang: JP