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临床试验/NCT02860117
NCT02860117撤回3 期

The Effectiveness of Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients, a Randomized, Double-blind, Placebo-controlled Study

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家开始时间: 2018年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in the control of pain intensity, the impact on the consumption of opioids and observe the side effect profile in patients suffering from great extent of burns.

详细描述

Despite advances in pharmacology and in analgesic techniques, pain in burned patients is unwieldy yet, this occurs in such cases due to the complexity and intensity and the need for multidisciplinary medical team. The burn pain is classified as nociceptive, but can also present a neuropathic component. Overall this is a pain at rest and during movement, being aggravated by procedures like changing dressings. In the weeks after the burn there is intense pain due to injury and the management of the framework, which often involves dressing changes and other procedures such as surgery in donor area skin.

The use of opioids in high doses can lead to unwanted side effects.To reduce the adverse effects resulting from the use of opioids in high doses, we purpose the use of intravenous continuous infusion of ketamine. In controlling the pain of major burned patient there is evidence only of the use of ketamine in the form of intermittent boluses, especially during dressing changes or in the perioperative period. The use of ketamine in continuous infusion lacks evidence in this group of patients The purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in the control of pain intensity, the impact on the consumption of opioids and observe the side effect profile in patients suffering from great extent of burns.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ketatamine

Active Comparator

Ketamine continuous infusion 0,2mg/kg/h

干预措施: Ketamine continuous infusion (Device)

Placebo

Placebo Comparator

Placebo in continuous infusion

干预措施: Placebo (Drug)

结局指标

主要结局

Opioid consumption

时间窗: up to 10 days

Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention

次要结局

  • Side effects questionnaire(up to 10 days)

研究者

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

Felipe Chiodini Machado

Anesthesiologist, Member of USaoPauloGH Pain Management staff, Principal investigator

University of Sao Paulo General Hospital

研究点 (1)

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