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Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02222246
Recruitment Status : Completed
First Posted : August 21, 2014
Results First Posted : August 4, 2017
Last Update Posted : August 4, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of Cincinnati
Mount Sinai Hospital, New York
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Hydromorphone (Standardized, weight-based dosing) Drug: Morphine Sulfate (Standardized, weight-based dosing) Drug: Hydromorphone (Patient Specific dosing) Drug: Morphine Sulfate (Patient Specific dosing) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
Actual Study Start Date : March 15, 2015
Actual Primary Completion Date : May 31, 2016
Actual Study Completion Date : June 30, 2016


Arm Intervention/treatment
Experimental: Patient Specific dose of Morphine Sulfate or Hydromorphone
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)
Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
Other Name: Dilaudid

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.

Active Comparator: Standard dose of Morphine Sulfate or Hydromorphone
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)
Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
Other Name: Dilaudid

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).




Primary Outcome Measures :
  1. Difference in Pain Score as Measured by a Visual Analogue Scale (VAS) [ Time Frame: Arrival in ED to discharge from the ED, up to 6 hours ]
    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.


Secondary Outcome Measures :
  1. Change in Pain Visual Analogue Scale (VAS) Scores Over Time [ Time Frame: Every 30 minutes from arrival in ED to discharge from the ED, up to 6 hours ]

    Pain severity was assessed at arrival and every 30 minutes until discharge from the 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.

    A hierarchical random coefficients regression model for repeated measurements (type of mixed hierarchical mixed-effect model) was conducted on the pain scores collected at six time points (arrival, post-placement 30-min, 60-min, 90-min,120-min, discharge) to evaluate the trajectory of change in pain. Discharge occurred at 120 minutes or later during each visit, with the exception of one discharge at 54 minutes.


  2. Incidence of Nausea During Emergency Department Visits [ Time Frame: From placement in Emergency Department (ED) treatment room to discharge from the ED, up to 6 hours ]
    Nausea at any point from placement until discharge, based on nausea data collected every 30 minutes during that time period. Thus, a nausea variable was derived in which 0=no and 1=yes that nausea was reported by the patient at least once during the placement to discharge time interval.

  3. Incidence of Vomiting During Emergency Department Visits [ Time Frame: From placement in ED treatment room to discharge from the ED, up to 6 hours ]
    Vomiting at any point from placement until discharge, based on vomiting data collected every 30 minutes during that time period. Thus, a vomiting variable was derived in which 0=no and 1=yes that vomiting was reported by the patient at least once during the placement to discharge time interval.

  4. Incidence of a Decrease in Systolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit [ Time Frame: From placement in ED treatment room to discharge from the ED, up to 6 hours ]
    Decrease in systolic blood pressure at any point from placement until discharge, based on blood pressure data collected every 30 minutes during that time period. A systolic variable was derived in which 0=no and 1=yes that a >= 20% decrease of baseline systolic blood pressure was reported by the patient at least once during the placement to discharge time interval.

  5. Incidence of a Decrease in Diastolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit [ Time Frame: From placement in ED treatment room to discharge from the ED, up to 6 hours ]
    Decrease in diastolic blood pressure at any point from placement until discharge, based on blood pressure data collected every 30 minutes during that time period. A diastolic variable was derived in which 0=no and 1=yes that a > 20% decrease of baseline diastolic blood pressure was reported by the patient at least once during the placement to discharge time interval.

  6. Incidence of Oxygen Desaturation (< 95%) (YES) During Emergency Department Visit [ Time Frame: From placement in ED treatment room to discharge from the ED, up to 6 hours ]
    Saturation of peripheral capillary oxygen < 95% (SPO2 < 95%) at any point from placement until discharge, based on SPO2 data collected every 30 minutes during that time period. Thus, a SPO2 variable was derived in which 0=no and 1=yes that SPO2 < 95% was reported by the patient at least once during the placement to discharge time interval.

  7. Incidence of Respiratory Distress (YES) During Emergency Department Visit [ Time Frame: From placement in ED treatment room to discharge from the ED, up to 6 hours ]
    Respiratory distress at any point from placement until discharge, based on data collected every 30 minutes during that time period. Thus, a respiratory distress variable was derived in which 0=no and 1=yes that respiratory distress was reported by the patient at least once during the placement to discharge time interval.

  8. Incidence of Sedation During Emergency Department Visit [ Time Frame: From placement in ED treatment room to discharge from the ED, up to 6 hours ]
    Severe-to moderate sedation at any point from placement until discharge, based on sedation data collected every 30 minutes during that time period. Thus, a sedation variable was derived in which 0=no and 1=yes that moderate-severe sedation was reported by the patient at least once during the placement to discharge time interval. Sedations scoring was as follows: None was defined as "awake and alert", Mild sedation was defined as "responds to voice", Moderate sedation was defined as "responds to touch, with or without voice" and Severe sedation was defined as "somnolent, difficult to arouse".

  9. Incidence of the Need for Supplemental Oxygen During Emergency Department Visit [ Time Frame: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours ]
    Need for supplemental oxygen during the Emergency Department stay; this was determined at discharge.

  10. Incidence of the Administration of Naloxone During Emergency Department Visit [ Time Frame: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours ]
    Naloxone administered during the Emergency Department stay; this was determined at discharge.

  11. Incidence of the Need for Assistive Ventilation [ Time Frame: Following the initiation of opioid therapy until discharge from the ED, up to 6 hours ]
    Intubation or other assistive ventilation techniques - including bag, valve, or mask was performed during the ED stay; this was determined at discharge.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222246


Locations
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of Cincinnati
Mount Sinai Hospital, New York
Investigators
Principal Investigator: Paula Tanabe, PhD Duke University School of Nursing

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02222246     History of Changes
Other Study ID Numbers: Pro00054047
R34 RHL121224A ( Other Grant/Funding Number: NHLBI )
First Posted: August 21, 2014    Key Record Dates
Results First Posted: August 4, 2017
Last Update Posted: August 4, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Duke University:
Sickle Cell Disease
Emergency Department
Vaso-occlusive Crisis
Pain Management
Pilot Project

Additional relevant MeSH terms:
Anemia, Sickle Cell
Acute Pain
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Hydromorphone
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents