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临床试验/NCT01112540
NCT01112540已完成4 期

Morphine in Acute Abdominal Pain

Akdeniz University1 个研究点 分布在 1 个国家开始时间: 2010年4月28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
试验地点
1
主要终点
Our primary outcome measure was the clinically important change in diagnostic accuracy and physical examination in the morphine vs. placebo group.

研究概览

简要总结

The investigators primary outcome measure was the clinically important change in diagnostic accuracy and physical examination in the morphine vs. placebo group. After follow up information was obtained and patients data were recorded on the SPSS data chart, two blinded coauthors (general surgeon and emergency physician) determined the clinically important diagnostic accuracy and change in physical examination. They firstly defined clinically important diagnostic errors, as any disagreement between the preliminary and final diagnosis that might be expected to have adverse effect on the patient's general status. If coauthors decided an instance of diagnostic error as clinically important, this was coded "diagnostic discordance" for statistical analysis. While the preliminary diagnosis was determined as accurate or not different from the final diagnosis, this was coded "diagnostic accuracy" for statistical analysis. Secondary outcome measures included the need for rescue drugs at 30 minutes, the presence of at least one adverse event, demographic features and final diagnosis of the patients.

研究设计

研究类型
Interventional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly (65 years or older) patients with non-traumatic UAP of less than 48 hours' duration were included in the study. Participants were required to have a UAP and report either "mild" or greater pain intensity on a four-point verbal rating scale (VRS) or at least 20 mm on a 100 mm visual analogue scale (VAS).

排除标准

  • Exclusion criteria included known allergy or contraindication to morphine, or any opioid analgesic
  • Hemodynamic instability (systolic blood pressure less than 100 mm-Hg)
  • Use of any analgesic within 6 hours before ED presentation
  • Patients refused to participate to the study
  • Incooperated to the VAS
  • Isolated flank pain or previous study enrollment
  • Patients with known renal, pulmonary, cardiac or hepatic failure were also excluded.

研究组 & 干预措施

Placebo Group

Placebo Comparator

干预措施: Morphine (Drug)

Morphine

Experimental

干预措施: Morphine (Drug)

结局指标

主要结局

Our primary outcome measure was the clinically important change in diagnostic accuracy and physical examination in the morphine vs. placebo group.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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Morphine in Acute Abdominal Pain | 临床试验