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临床试验/NCT03541980
NCT03541980已完成4 期

Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?

Newark Beth Israel Medical Center1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2018年2月20日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Patients allocated to receive IV acetaminophen

干预措施: Acetaminophen (Drug)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cena Tejani

Principal Investigator

Newark Beth Israel Medical Center

研究点 (1)

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