Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Cumulative Opioid Dosing
研究概览
简要总结
The purpose of this study is to determine whether IV acetaminophen can decrease the need for subsequent opioid administration in the acute management of sickle cell crisis pain in the pediatric emergency room.
详细描述
This is a single-center, prospective, randomized, double-blinded, controlled study in an academic urban pediatric emergency department of children with sickle cell disease presenting with acute sickle cell crisis pain between ages of 4 to 16 years, with a pain score of 6/10 or higher on the Wong-Baker modified FACES pain scale. In order to detect a difference of 0.2 mg/kg in cumulative dosage of morphine (at our institution, 0.3 mg/kg morphine deems an inpatient admission for parenteral pain management) with 80% power and alpha of 0.05, we calculated a sample size of 33 patients in each group. All patients will receive IV ketorolac and IV morphine. Patients will be randomized to receive IV acetaminophen or IV saline (volume-equivalent). Pain scores will be obtained at baseline, and again at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after medication administration. Cumulative morphine dosing, rates of admission, and rates of adverse effects of morphine will also be analyzed. Our primary objective is to decrease the need for subsequent opioid administration. Our secondary objectives are to determine if IV Acetaminophen decreases pain score at 30 minutes, 60 minutes, 90 minutes, and 120 minutes, decreases the rate of admissions, and decreases the rate of adverse effects from opioids.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient age 4-16 years with sickle cell disease who presents the Pediatric ER with acute sickle cell pain crisis with a pain of 6/10 or higher
排除标准
- •Patient with fever (38C or 100.4F)
- •Patient less than age 4 years
- •Patient greater than age 16 years
- •Patient with hypersensitivity/allergy to either morphine, NSAIDs, or acetaminophen
- •Patient received acetaminophen within the past 4 hours
- •Patient with known liver disease or renal disease
- •Patient not requiring IV morphine (pain score 5/10 or less)
- •Patient enrolled in the study within the past 72 hours
研究组 & 干预措施
Intervention
Patients allocated to receive IV acetaminophen
干预措施: Acetaminophen (Drug)
Placebo
Patients allocated to receive IV normal saline placebo
干预措施: Normal saline (Drug)
结局指标
主要结局
Cumulative Opioid Dosing
时间窗: 120 minutes
Total dosing of opioid given after initial evaluation in mg/kg
次要结局
- Percentage of the Patients Reporting Satisfaction(120 minutes)
- Inpatient Admission(120 minutes)
- Pain Scores(at disposition)
- Adverse Effects(120 minutes)
研究者
Cena Tejani
Principal Investigator
Newark Beth Israel Medical Center
