The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Visual Analog Score for Pain
研究概览
简要总结
The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar Treatment of Fractional CO2 Laser
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Age: 18-60 years old, regardless of gender;
- •Clinical diagnosis of atrophic acne scars;
- •Planning to undergo ultra-pulsed CO2 lattice laser therapy;
- •The patient agrees to participate in this experiment and signs an informed consent form
排除标准
- •Those who take sedative drugs for a long time;
- •Patients with sleep apnea syndrome, previous history of hypertension, and blood pressure greater than 160/100mmHg
- •People with severe heart and lung diseases, liver and kidney diseases, psychosis, pregnancy, and communication disorders;
- •Persons who are known to be allergic to the main drug or any of the excipients in Dezocine injection;
- •Increased intracranial pressure or head injury;
- •Acute and chronic alcoholism;
- •People with hypotension, hypothyroidism, acute episodes of asthma, and epilepsy
研究组 & 干预措施
control group
The patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline).
干预措施: Fractional CO2 laser (Device)
Dezocine low dose group
The patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline).
干预措施: Fractional CO2 laser (Device)
Dezocine low dose group
The patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline).
干预措施: Dezocine (Drug)
Dezocine high dose group
The patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline).
干预措施: Fractional CO2 laser (Device)
Dezocine high dose group
The patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline).
干预措施: Dezocine (Drug)
结局指标
主要结局
Visual Analog Score for Pain
时间窗: 24 hours
0 was classified as painless and 10 was classified as unbearable pain. Marks were made on the corresponding parts of the ruler and scores were scored according to the degree of patient's feeling
Hemodynamic parameters
时间窗: 24 hours
diastolic blood pressure (DBP), systolic blood pressure (SBP)
Heart rate (HR)
时间窗: 24 hours
Hemodynamic parameters
oxygen saturation (SpO2)
时间窗: 24 hours
Hemodynamic parameters
次要结局
- Occurrence of Adverse Reactions(24 hours)