A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 328
- 试验地点
- 6
- 主要终点
- The Change in Pain Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult (18 years or older);
- •Sickle Cell Disease patients with the following genotypes: Hgb SS (sickle cell anemia), SC(Sickle hemoglobin-c) , and SB+(sickle Beta-Plus thalassemia) and SB-(sickle Beta zero thalassemia)
排除标准
- •determined to not benefit from opioids and therefore won't receive opioids in any future Emergency Department visit.
研究组 & 干预措施
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.
干预措施: Patient-Specific Protocol (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, 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.
干预措施: Morphine (Drug)
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.
干预措施: Hydromorphone (Drug)
Weight-based Protocol
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.
干预措施: Weight-based Protocol (Other)
Weight-based Protocol
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.
干预措施: Morphine (Drug)
Weight-based Protocol
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.
干预措施: Hydromorphone (Drug)
结局指标
主要结局
The Change in Pain Score
时间窗: baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first
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.
次要结局
- Number of Participants Experiencing Side Effects(Bed placement to discharge or 6 hours, whichever comes first)
- Length of Index ED (Emergency Department) Stay(From bed placement to discharge or 6 hours whichever comes first)
- Length of Care(up to 6 hours)
- Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment(Up to 7 days post enrollment)