The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar Treatment of Fractional CO2 Laser

Study Overview
=================
Brief Summary
-----------------
The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar Treatment of Fractional CO2 Laser

Official Title
-----------------
The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar

Conditions
-----------------
Acne Atrophica

Intervention / Treatment
-----------------
* Device: Fractional CO2 laser
* Drug: Dezocine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>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). | Device: Fractional CO2 laser<br>* All patients were given oral administration of 0.5mg paronosetron hydrochloride and lidocaine cream 1 hour before surgery. After cleaning and disinfection, fractional CO2 laser treatment was given. Among them, the fractional CO2 laser laser (American Medical Laser company) selected relatively constant energy parameters in the treatment<br>* Other names: paronosetron hydrochloride and lidocaine cream;|
| Experimental: Dezocine low dose group<br>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). | Device: Fractional CO2 laser<br>* All patients were given oral administration of 0.5mg paronosetron hydrochloride and lidocaine cream 1 hour before surgery. After cleaning and disinfection, fractional CO2 laser treatment was given. Among them, the fractional CO2 laser laser (American Medical Laser company) selected relatively constant energy parameters in the treatment<br>* Other names: paronosetron hydrochloride and lidocaine cream;Drug: Dezocine<br>* Desocine injection was injected intravenously half an hour before surgery (10ml normal saline was added for more than 30 seconds)<br>|
| Experimental: Dezocine high dose group<br>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). | Device: Fractional CO2 laser<br>* All patients were given oral administration of 0.5mg paronosetron hydrochloride and lidocaine cream 1 hour before surgery. After cleaning and disinfection, fractional CO2 laser treatment was given. Among them, the fractional CO2 laser laser (American Medical Laser company) selected relatively constant energy parameters in the treatment<br>* Other names: paronosetron hydrochloride and lidocaine cream;Drug: Dezocine<br>* Desocine injection was injected intravenously half an hour before surgery (10ml normal saline was added for more than 30 seconds)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score for Pain | 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 | 24 hours | 
| Hemodynamic parameters | diastolic blood pressure (DBP), systolic blood pressure (SBP) | 24 hours | 
| Heart rate (HR) | Hemodynamic parameters | 24 hours | 
| oxygen saturation (SpO2) | Hemodynamic parameters | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Reactions | Nausea, vomiting，dizziness，respiratory depression | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne Scar, Dezocine, Pain Relief, Fractional CO2 Laser