Tolerance Assesment of the Usage of an Analgesic Dose of Esketamine for Treatment of Moderate to Intense Pain in an Emergency Departement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- ESKETAMINE adverse reactions
研究概览
简要总结
KETAMINE has been used for several years in emergency departments for analgesic purposes. Its ease of use and its analgesic effect have been demonstrated in several studies.
Nevertheless, this molecule is not devoid of side effects, in particular the very frequent occurrence of nausea, vomiting, anxiety, an overall feeling of discomfort and more rarely hallucinations, feelings of unreality, or tachycardia.
Recently, ESKETAMINE, used as an anesthetic but also in the USA as an antidepressant, has obtained its Marketing Authorization in the management of moderate to severe pain. ESKETAMINE corresponds to the S-(-)-KETAMINE enantiomer. Like KETAMINE, it acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor but unlike KETAMINE does not interact, with the sigma receptors responsible for hallucinations and delusional symptoms. ESKETAMINE aimed at anesthetic is about twice as potent as KETAMINE and would also be eliminated more quickly.
Studies suggest that at equivalent doses, ESKETAMINE would be better tolerated than the KETAMINE usually used in emergency departments.
In this study, the tolerance of ESKETAMINE used at analgesic doses for treatment of moderate to severe pain will be assessed in an emergency departement
A wider usage of ESKETAMINE for analgesia purpose in emergency departments is expected, with a better tolerance for the patients compared to KETAMINE
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is 18 years old or more
- •Moderate to severe pain as assessed by the patient with a verbal numerical rating scale (NRS) of 6/10 or more ; NRS goes from 0 (no pain) to 10 (the worst pain imaginable)
- •Physician has decided to use ESKETAMINE
- •Patient is not opposed to enroll in the study after having been informed, as attested by the physician in the patient's file
排除标准
- •Adult under juridic protection, under guardianship, under curatorship
- •Patient unable to express his consent
- •Patient deprived of liberty by a judicial or administrative decision
- •Pregnant, parturient or nursing mother
- •Patients physically or mentally unable to answer the questionnaire
- •Typical kidney colic pain
结局指标
主要结局
ESKETAMINE adverse reactions
时间窗: From beginning of perfusion (T0) to patient exit of the emergency department (up to 4 hours after T0)
Enumeration of the adverse reactions occuring to the patient as collected by the investigator in the patient file and by the patient in the study questionnaire
次要结局
- Pain self assesment T0(b)(beginning of perfusion (T0))
- Pain self assesment T30(b)(30 minutes after the beginning of perfusion (T0 + 30 minutes))
- Patient satisfaction about his treatment (T30)(30 minutes after the beginning of perfusion (T0 + 30 minutes))
- Patient satisfaction about his treatment (T15)(15 minutes after the beginning of perfusion (T0 + 15 minutes))
- Pain self assesment T0(a)(beginning of perfusion (T0))
- Pain self assesment T15(a)(15 minutes after the beginning of perfusion (T0 + 15 minutes))
- Pain self assesment T30(a)(30 minutes after the beginning of perfusion (T0 + 30 minutes))
- Pain self assesment T15(b)(15 minutes after the beginning of perfusion (T0 + 15 minutes))