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

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

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

Study Overview

• Status: Recruiting
• Conditions: Acne Atrophica
• Intervention / Treatment: Device: Fractional CO2 laser; Drug: Dezocine

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Chen Yu, MD; Phone Number: 86 13571991903; Email: ycyc_2005@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Dermatology Derpartment of Xijing Hospital
      • Contact: Gang Wang, prof; Phone Number: +8684775401; Email: xjwgang@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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).	Device: Fractional CO2 laser; 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; Other Names: paronosetron hydrochloride and lidocaine cream
Experimental: 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).	Device: Fractional CO2 laser; 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; Other Names: paronosetron hydrochloride and lidocaine cream; Drug: Dezocine; Desocine injection was injected intravenously half an hour before surgery (10ml normal saline was added for more than 30 seconds)
Experimental: 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).	Device: Fractional CO2 laser; 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; Other Names: paronosetron hydrochloride and lidocaine cream; Drug: Dezocine; Desocine injection was injected intravenously half an hour before surgery (10ml normal saline was added for more than 30 seconds)

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Gang Wang, Prof, Dermatology Derpartment of Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2023
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Acne Scar, Dezocine, Pain Relief, Fractional CO2 Laser
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Dezocine
• Other Study ID Numbers: XijingH-PF-20232019-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No