PCA for Pain Control in Adults With Sickle Cell Disease in the Emergency Department (ED) Decreases Admission Rates Over Standard Bolus Therapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing
研究概览
简要总结
This research is being done to find out the best way to give narcotics for pain relief in adults with sickle cell disease and painful crisis. This study is a comparison of two ways of giving narcotics. The first way is what occurs now in the Emergency Acute Care Unit (EACU) where patients are given a single intravenous (iv) dose of a narcotic which is repeated by the nurse as needed to control the pain. The second way is to provide a single iv dose of narcotic and then allow the patient to push a button and receive one or more additional doses of narcotic when he/she thinks it is needed. Our hypothesis is that PCA will be a more effective way of controlling pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented sickle cell disease
- •Signed consent in outpatient clinic or during a prior hospitalization
- •18+ years of age
- •Seen in the ED with sickle cell pain crisis - this will be based on patients chief complaint that they are in a VOC.
- •Requires IV administration of narcotics (has failed oral narcotic therapy at home)
- •Must be 2 weeks since their last randomization on this study.
排除标准
- •Contraindication to the use of IV narcotics
- •Hypotension with systolic blood pressure (SBP) ≤ 90
- •Respiratory rate ≤9
- •Altered mental status
- •Patient unable to understand how to use the PCA device
- •Patient unwilling to use PCA device
- •Pulse oximeter reading of ≤ 94% on room air
- •Patient is allergic to IV morphine & hydromorphone & fentanyl.
- •Patient is allergic to oral hydromorphone & morphine & oxycodone
- •Patient has been randomized on this study 3 times before
研究组 & 干预措施
1
In this arm patients will be randomized to receive a bolus of narcotic followed by PCA.
干预措施: Patient controlled analgesia (Procedure)
2
In this arm patients will be randomized to the current standard of care of bolus narcotic treatment.
干预措施: nurse-administered intermittent IV bolus opioid therapy (NAIBOD) (Drug)
结局指标
主要结局
Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing
时间窗: Measured at time of discharge from ED
次要结局
- Length of stay(Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made)
- Total narcotic used(Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made)