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临床试验/NCT01827475
NCT01827475已完成2 期

Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting

Stony Brook University0 个研究点目标入组 90 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
90
主要终点
Pain Severity

研究概览

简要总结

The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department.

详细描述

The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department. We hypothesize that the combination will be more effective than either agent alone in patients presenting to the emergency department with acute pain from musculoskeletal injuries such as sprain, and bruises. While each agent alone is effective to some degree, many patients do not find complete relief with them and often narcotic agents (with all of their potential side effects) are added. In this study patients experiencing any pain will be randomly given either ibuprofen OR acetaminophen OR their combination and their degree of pain severity will be measured every 15 minutes up to one hour. At the end of this 1 hour patients still experiencing pain and requiring additional pain relief will receive additional analgesics at the discretion of their treating physician. We will not only measure how much the pain severity was reduced but also the percentage of patients that require some form of additional or "rescue" medication.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who presented to the emergency department with pain (a verbal numeric pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an acute musculoskeletal injury of less than 24 hours of duration when one of the study investigators was present were eligible for enrollment

排除标准

  • Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.

研究组 & 干预措施

Ibuprofen

Active Comparator

Ibuprofen 800 mg

干预措施: Ibuprofen (Drug)

Acetaminophen

Active Comparator

Acetaminophen 1 gm

干预措施: Acetaminophen (Drug)

Ibuprofen-acetaminophen combination

Experimental

Ibuprofen 800 mg plus acetaminophen 1 gm

干预措施: Ibuprofen-acetaminophen combination (Drug)

结局指标

主要结局

Pain Severity

时间窗: 1 hour

Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)

次要结局

  • Need for Rescue Pain Relief(1 hour)

研究者

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

Adam Singer

Professor and Vice Chair

Stony Brook University

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