Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease

NCT02222246 | Completed Phase 4 Results DMC

• 2 other identifiers: Pro00054047R34 RHL121224A
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Sickle Cell Disease; Emergency Department; Vaso-occlusive Crisis; Pain Management; Pilot Project

Outcome Measures

Primary Outcomes (1)

• Difference in Pain Score as Measured by a Visual Analogue Scale (VAS)

  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 to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED. Thus, the difference in pain scores were calculated as the arrival minus discharge VAS scores, with higher positive pain difference or change scores indicating greater pain reduction.

  Arrival in ED to discharge from the ED, up to 6 hours

Secondary Outcomes (11)

• Change in Pain Visual Analogue Scale (VAS) Scores Over Time

  Every 30 minutes from arrival in ED to discharge from the ED, up to 6 hours

• Incidence of Nausea During Emergency Department Visits

  From placement in Emergency Department (ED) treatment room to discharge from the ED, up to 6 hours

• Incidence of Vomiting During Emergency Department Visits

  From placement in ED treatment room to discharge from the ED, up to 6 hours

• Incidence of a Decrease in Systolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit

  From placement in ED treatment room to discharge from the ED, up to 6 hours

• Incidence of a Decrease in Diastolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit

  From placement in ED treatment room to discharge from the ED, up to 6 hours

Study Arms (2)

Patient Specific dose of Morphine Sulfate or Hydromorphone

EXPERIMENTAL

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.

Drug: Hydromorphone (Patient Specific dosing); Drug: Morphine Sulfate (Patient Specific dosing)

Standard dose of Morphine Sulfate or Hydromorphone

ACTIVE COMPARATOR

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.

Drug: Hydromorphone (Standardized, weight-based dosing); Drug: Morphine Sulfate (Standardized, weight-based dosing)

Interventions

Hydromorphone (Standardized, weight-based dosing) DRUG

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

Also known as: Dilaudid

Standard dose of Morphine Sulfate or Hydromorphone

Morphine Sulfate (Standardized, weight-based dosing) DRUG

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

Standard dose of Morphine Sulfate or Hydromorphone

Hydromorphone (Patient Specific dosing) DRUG

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

Also known as: Dilaudid

Patient Specific dose of Morphine Sulfate or Hydromorphone

Morphine Sulfate (Patient Specific dosing) DRUG

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

Patient Specific dose of Morphine Sulfate or Hydromorphone

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult SCD patients with genotypes SS, SC, SB+, or SB-

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Cincinnati: collaborator
• Mount Sinai Hospital, New York: collaborator

Study Sites (2)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Emergencies; Vaso-Occlusive Crises; Agnosia

Interventions

Hydromorphone; Morphine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Paula Tanabe
• Organization: Duke University

paula.tanabe@duke.edu

919-613-6038

Study Officials

• Paula Tanabe, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: March 15, 2015
• Primary Completion: May 31, 2016
• Study Completion: June 30, 2016
• Last Updated: August 4, 2017
• Results First Posted: August 4, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)