The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
328
Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home for pain and what was needed during their past hospital and emergency department visits to treat pain. Medicines will include opioids, either morphine or hydromorphone. A member of the outpatient SCD provider team will review the patient's medical record to determine: 1) the patient's maximum home opioid dose, and 2) previous ED analgesic medication(s) and doses that have been effective and safe in the past. The patient's regular hematologist/sickle cell team will write the treatment plans. Medications will be given every 20-30 minutes for up to 6 hours.
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team.
University of Maryland
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Atrium Health
Charlotte, North Carolina, United States
The Change in Pain Score
Pain is measured by having the patient mark pain on a scale of 0 to 100, with 0 being no pain and 100 being the worst pain ever. Pain scores were initially measured using a 0-100 millimeter visual analog scale with higher (closer to 100 being worse); however during the COVID-19 pandemic, one site removed paper forms from the emergency department as an infection control measure. The protocol was amended to add collection of a 0-100 verbal numerical rating scale and sites were ask to obtain both a vision and verbal score if possible collecting the visual score first. For the analysis, the visual score was used if available for the primary outcome. if not available, the verbal score was used.
Time frame: baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first
Length of Index ED (Emergency Department) Stay
Length of index ED stay in hours from bed placement to discharge
Time frame: From bed placement to discharge or 6 hours whichever comes first
Length of Care
Length of care from bed placement to last drug dose in hours.
Time frame: up to 6 hours
Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment
Number of hospitalizations for Vaso-Occlusive Episode (VOE) within 7 days following enrollment
Time frame: Up to 7 days post enrollment
Number of Participants Experiencing Side Effects
Side effects and safety at any time during the emergency department visit
Time frame: Bed placement to discharge or 6 hours, whichever comes first
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4 mg for participants weighing \<50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.
1 mg for participants weighing \<60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.
Case Western University
Cleveland, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States