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

Air Force Military Medical University of People's Liberation Army

Status and phase: Enrolling; Phase 4

Conditions: Acne Atrophica

Treatments: Drug: Dezocine; Device: Fractional CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05861063

XijingH-PF-20232019-F-1

Details and patient eligibility

About

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

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

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).

Treatment:

Device: Fractional CO2 laser

Dezocine low dose group

Experimental group

Description:

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).

Treatment:

Drug: Dezocine

Device: Fractional CO2 laser

Dezocine high dose group

Experimental group

Description:

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).

Treatment:

Drug: Dezocine

Device: Fractional CO2 laser