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临床试验/NCT01906762
NCT01906762已完成2 期

Comparing the Effect of Intravenous Morphine and Injectable Acetaminophen on Renal Colic Patients Presenting to the Emergency Department: A Randomized Controlled Trial

Seyed Mehdi Pourafzali0 个研究点目标入组 124 人开始时间: 2012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
发起方
入组人数
124
主要终点
Pain

研究概览

简要总结

Kidney stone is one of the most common diseases in every human society and also Iran. What is normally used to treat renal colic pain is Intravenous Opioid with a variety of side effects including hypotension, respiratory depression and apnea, nausea and vomiting. Regarding less complications of Intravenous Acetaminophen, we aimed to compare it with Intravenous Morphine in management of renal colic pain.

详细描述

Kidney stone is one of the common diseases of human society which is demonstrated in the form of renal colic. Evidences indicate that renal colic is one of the mot painful conditions that require urgent pain relief treatment.

Patients suffering from renal colic do not usually recover from pain by using oral pain killers or rectal suppositories. Hence, a considerable percentage of these patients are admitted to the emergency department. A bothering and sharp pain is the most common characteristics of renal colic pain that wakes the patient up in the middle of the night. To achieve more relief, patients somehow take unusual positions such as squatting.

What are normally used as pain relievers in emergency department are Non-steroidal anti-inflammatory drugs (NSAIDs) and intravenous Opioids. However, both of these classes of drugs have many side effects.

Another point in this regard which is worthy to be mentioned is that some patients with renal colic complaint are drug addicted, so we have to administer higher dosage of analgesic drugs. According to the statistics provided by the US National Library website, the prevalence of kidney stones around the world in 2005 has been averagely around 140.1% which is considerable. This issue suggests more attention to the field of prevention and treatment.

According to the statistics of kidney stones incidence in Iran, 2.4 out of every 1000 people suffer from this pathologic condition whereas it differs from 0.5 to 2 in every 1000 ones in other countries.

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
Double (Participant, Care Provider)

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 15 to 80 years
  • weight of 60 to 80 kilograms
  • known case of renal colic based on physical examination and Ultrasonography

排除标准

  • Addiction
  • allergic to Opioids and Acetaminophen
  • receiving any types of analgesic drugs within previous 6 hours
  • known cases of Kidney transplantation
  • Patients with known heart failure
  • Patients with known Liver failure
  • Patients with known Respiratory failure
  • Patients with known Renal failure
  • cases of Blindness and physical disabilities not able to communicate

研究组 & 干预措施

Acetaminophen

Experimental

Specified dosage for Acetaminophen was 15 mg/kg. so based on the patient's weight(averagely 70 kg), about 1gr Acetaminophen (one complete Apotel Ampule) was used.

干预措施: Acetaminophen (Drug)

Morphine

Experimental

Specified dosage for Morphine was 0.1 mg/kg. so based on the patient's weight(averagely 70 kg), about 7 mg Morphine was used.

干预措施: Morphine (Drug)

结局指标

主要结局

Pain

时间窗: 30 Minutes

patient's pain was assessed by using a Visual Analog Scale Ruler, that rates the amount of pain from 0 to 10 based on patient's confession. Patient's pain was checked out twice: exactly before receiving the pain reliever, and 30 minutes later.

次要结局

未报告次要终点

研究者

发起方
Seyed Mehdi Pourafzali
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seyed Mehdi Pourafzali

Emergency Medicine Specialist

Isfahan University of Medical Sciences

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