COMPARE-VOE: Comparing Individualized vs. Weight Based Protocols to Treat VOE in SCD Occlusive Episodes in Sickle Cell Disease
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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%.
Other Names:
Drug: Hydromorphone
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%.
Other Names:
|
| 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
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%.
Other Names:
Drug: Hydromorphone
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%.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in pain scores as measured by patient reported pain level. [baseline (hospital admission), up to 6 hours (hospital discharge)]
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.
Secondary Outcome Measures
- Average length of study in the emergency department [Up to 6 hours]
- Number of return ED visits within the next 7 days [up to 7 days]
- Number of hospitalizations for Vaso- Occlusive Episode (VOE) within the next 7 days [Up to 7 days]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Maryland | Baltimore | Maryland | United States | 21201 |
| 2 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 3 | Wayne State University | Detroit | Michigan | United States | 48202 |
| 4 | Atrium Health | Charlotte | North Carolina | United States | 28204 |
| 5 | Case Western University | Cleveland | Ohio | United States | 44106 |
| 6 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
Sponsors and Collaborators
- Duke University
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Huiman Barnhart, PhD, Duke University
- Principal Investigator: Paula Tanabe, PhD, Duke University School of Nursing
Study Documents (Full-Text)
More Information
Publications
None provided.- Pro00101245
- 1U24HL137907-01A1