NCT04833816已完成3 期
Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Total dose of sufentanil
研究概览
简要总结
The aim of this study is to demonstrate a significant reduction of at least 25% in opioid consumption at 48 hours of management of severe trauma, while demonstrating non-inferiority in terms of analgesia, in a group of patients receiving a continuous infusion of low dose ketamine compared to a placebo group.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult
- •Trauma patient presenting at least 2 lesions in two different regions as defined by the ISS (injury severity score) (Head or neck, Face, Thorax, Abdomen and pelvic contents, Upper limbs or pelvic girdle, Lower limbs, External (any skin surface).
- •Patient presenting at least two regional disorders classified as moderate to maximum defined by an AIS (Abbreviated Injury Scale)>
- •Patient having signed an informed consent
排除标准
- •Patients with an indication for deep sedation (intracranial hypertension or acute respiratory distress syndrome).
- •Patient in whom the infusion could not be started within the first 6 hours of initial treatment.
- •Patient whose state of consciousness is incompatible with understanding the protocol.
- •Patient with chronic unbalanced arterial hypertension.
- •Patient with severe heart failure.
- •Patient with a BMI> 35 kg / m² or a weight of more than 120 kg.
- •Patient with chronic analgesic consumption defined by consumption of opioid derivatives for more than a week for an intercurrent illness.
- •Presence of a history of chronic pain.
- •Presence of a history of epilepsy.
- •Presence of a history of psychosis or drug addiction.
- •Presence of a history of stroke.
- •Patients with an allergy to the molecule or excipients composing ketamine
- •Patients with an allergy to the molecule or to the excipients making up sufentanil or paracetamol.
- •Pregnant or breastfeeding woman.
- •Patient not understanding French.
- •Protected adult patient (under guardianship, curatorship or legal protection).
研究组 & 干预措施
Ketamin
Experimental
Patient will get a bolus of ketamine at 0.1 mg / kg followed by a continuous infusion of ketamine at a dose of 0.15 mg / kg / hour
干预措施: Administration of drug (Drug)
Placebo
Placebo Comparator
Patient will get a bolus of NaCL at 0.1 mg / kg followed by a continuous infusion of NaCl at a dose of 0.15 mg / kg / hour
干预措施: Administration of drug (Drug)
结局指标
主要结局
Total dose of sufentanil
时间窗: 48 hours
All doses of sufentanil and opiods administration
次要结局
- Total amount of opiods(5 days)
- Pain assessment(5 days)
- Delirium(5 days)
- Global Quality of life(3 months)
- Chronical pain(3 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Low Dose Ketamine Study on Opioid Tolerance and HyperalgesiaIdiopathic ScoliosisSpondylolisthesisNCT01325493Julia Finkel54
已完成
4 期
Low Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency DepartmentPainNCT01835262Antonios Likourezos90
进行中（未招募）
1 期
Evaluation of ketamine on opiods consumption in traumatic patientTraumatismEUCTR2020-004812-81-FRASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE140
进行中（未招募）
1 期
Ketamine Low dOse Evaluation on morphine consumption in traumatic patientCTIS2023-510016-39-00Assistance Publique Hopitaux De Marseille140
撤回
2 期
Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone FracturesPain, AcuteNCT04061330The University of Texas Health Science Center, Houston