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

Phase 4

Recruiting

• Conditions: Acne Atrophica
• Interventions: Device: Fractional CO2 laser; Drug: Dezocine

• Registration Number: NCT05861063
• Lead Sponsor: Xijing Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-11
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Study First Posted: 2023-05-16
• Last Update Posted: 2023-05-16
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. Age: 18-60 years old, regardless of gender;
2. Clinical diagnosis of atrophic acne scars;
3. Planning to undergo ultra-pulsed CO2 lattice laser therapy;
4. The patient agrees to participate in this experiment and signs an informed consent form

Exclusion Criteria

1. Those who take sedative drugs for a long time;

2. Patients with sleep apnea syndrome, previous history of hypertension, and blood pressure greater than 160/100mmHg

3. People with severe heart and lung diseases, liver and kidney diseases, psychosis, pregnancy, and communication disorders;

4. Persons who are known to be allergic to the main drug or any of the excipients in Dezocine injection;

5. Increased intracranial pressure or head injury;

6. Acute and chronic alcoholism;

7. People with hypotension, hypothyroidism, acute episodes of asthma, and epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Fractional CO2 laser	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).
Dezocine low dose group	Fractional CO2 laser	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).
Dezocine high dose group	Fractional CO2 laser	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).
Dezocine low dose group	Dezocine	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).
Dezocine high dose group	Dezocine	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).

Primary Outcome Measures

Name	Time	Method
Visual Analog Score for Pain	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	24 hours	diastolic blood pressure (DBP), systolic blood pressure (SBP)
Heart rate (HR)	24 hours	Hemodynamic parameters
oxygen saturation (SpO2)	24 hours	Hemodynamic parameters

Secondary Outcome Measures

Name	Time	Method
Occurrence of Adverse Reactions	24 hours	Nausea, vomiting，dizziness，respiratory depression

Trial Locations

Locations (1)

Dermatology Derpartment of Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China