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临床试验/NCT03979105
NCT03979105已完成不适用

Cardiovascular and Neuropsychiatric Side Effects in Ketamine Analgesic Infusions in Acute Pain

Universidad de Antioquia2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年7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
已完成
入组人数
300
试验地点
2
主要终点
Tachycardia

研究概览

简要总结

Observational study that evaluate the cardiovascular and neuropsychiatric side effects of ketamine analgesic infusions for acute pain

详细描述

Severe acute pain and opioid tolerance is an important symptom in patients after surgery.

Ketamine in analgesic infusion has been described to decrease acute pain, in patients with opioid tolerance. Ketamine use has been associated with side effects, which are doses dependant. Those side effects are mainly cardiovascular: Hypertension, tachycardia, and neuropsychiatric: delirium, hallucinations,nightmares that potentially compromise recovery of patients.

Objective

To determine retrospectively in data bases the frequency of tachycardia, hypertension, delirium, hallucinations and nightmares, in adult patients that received ketamine infusions before and after administration of this drug in the first 48 hours to treat acute and postoperative pain

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patients older than 18 years old
  • Acute and Postoperative pain
  • Ketamine infusion at 0.15 mg/kg/h or below

排除标准

  • Cognitive disfunction psychiatric illness
  • Acute cardiovascular disease
  • Anemia with Hb less than 7 g/dl
  • Decompensated hyperthyroidism
  • Low cardiac output
  • Incomplete medical history

研究组 & 干预措施

Ketamine infusion

Ketamine infusion treatment for acute pain in adult population in all type of surgery that received adjuvant analgesia with ketamine 0.1mg/kg/h during 48 hours.

干预措施: Ketamine (Drug)

结局指标

主要结局

Tachycardia

时间窗: 2 days

Presence of absence of tachycardia (100 or above beats for minute) as physiological parameter recorded with cardioscope in the first 48 hours in clinical chart database after the infusion of ketamine has started.

Hypertension

时间窗: 2 days

Presence or absence of hypertension (140/90 mm Hg or above ) as physiological parameter recorded with electronic arm manometer in the first 48 hours in clinical chart database after the infusion of ketamine has started.

次要结局

  • Hallucinations(2 days)
  • Delirium(2 days)
  • Nightmares(2 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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