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临床试验/NCT01900847
NCT01900847终止不适用

Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department

University of Arizona1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2013年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
17
试验地点
1
主要终点
Numeric Pain Score

研究概览

简要总结

Our goal is to study whether giving people low dose ketamine along with morphine when they come to the Emergency Department will help their pain more than giving morphine by itself. There have been many studies showing that low dose ketamine is safe and effective for pain control. Ketamine is frequently used for pain control in ambulances and helicopters transporting injured patients to the hospital and has also been used for pain control in people who have just had surgery. The investigators would like to see if low dose ketamine would be safe and effective for patients with pain in the Emergency Department.

Patients are eligible for the study if they come to the Emergency Department and their treating physician decides to treat them with morphine (with certain exceptions such as pregnant patients and patients with eye injuries). They will be given information about participating in the study and if they agree, they will be given the study drug. The study drug will be either ketamine or salt water (saline). If patients continue to be in pain they will continue to receive doses of morphine just as they would if they were not in the study. If the treating physician feels that morphine alone is not enough, they will be free to choose another pain medication as they would normally.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presenting to Emergency Department in acute pain
  • age 18 and over
  • determined to require morphine for pain control by treating physician

排除标准

  • Patients presenting with headache or head injury
  • Patient with eye injury or eye pain
  • Nontraumatic chest Pain
  • Pregnant patients or women of childbearing potential
  • Patients allergic to morphine or ketamine
  • Patients with known history of narcotic/alcohol abuse or presenting for narcotic medication refill
  • Patients with hypertension: diastolic blood pressure > 100 OR systolic blood pressure > 180
  • Patient whose pain is so severe that they are unable to give informed consent
  • Patients who have had bad experiences to prior hallucinations from any origin

研究组 & 干预措施

Morphine and placebo

Active Comparator

Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy

干预措施: Morphine (Drug)

Morphine and placebo

Active Comparator

Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy

干预措施: placebo (Drug)

Morphine and Ketamine

Experimental

Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care

干预措施: Ketamine (Drug)

Morphine and Ketamine

Experimental

Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care

干预措施: Morphine (Drug)

结局指标

主要结局

Numeric Pain Score

时间窗: Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug

Pain 0-10 with 0 being no pain and 10 being the worst pain

次要结局

  • Total Amount of Morphine and Other Pain Medications Administered(Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours))
  • Number of Participants With Adverse Events(Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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