Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All adult (18 years or older);
  • SCD patients with the following genotypes: Hgb SS, SC, and SB+ and SB- thalassemia

Exclusion Criteria

  • determined to not benefit from opioids and therefore won't receive opioids in any future ED visit.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Patient-Specific Protocol
Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home, what was needed during their past hospital and emergency department visits to treat pain and doses that have been effective and safe in the past.
  • Other: Patient-Specific Protocol
    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.
  • Drug: Morphine
    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%.
    Other names:
    • Morphine Sulfate
  • Drug: Hydromorphone
    1 mg for participants weighing 50-69.9 kgs, 1.25 mg for participants weighing 60 - 69.9 kgs, 1.5 mg for participants weighing 70-89.9 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%.
    Other names:
    • Dilaudid
Experimental
Weight-based Protocol
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.
  • Other: Weight-based Protocol
    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.
  • Drug: Morphine
    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%.
    Other names:
    • Morphine Sulfate
  • Drug: Hydromorphone
    1 mg for participants weighing 50-69.9 kgs, 1.25 mg for participants weighing 60 - 69.9 kgs, 1.5 mg for participants weighing 70-89.9 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%.
    Other names:
    • Dilaudid

Recruiting Locations

University of Maryland
Baltimore, Maryland 21201
Contact:
Dana Beach, RN
dbeach3@som.umaryland.edu

More Details

NCT ID
NCT03933397
Status
Recruiting
Sponsor
Duke University

Study Contact

Beth Martinez
919-608-8094
beth.martinez@duke.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.