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

Acne Atrophica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861063
• Other study ID #: XijingH-PF-20232019-F-1
• Status: Recruiting
• Phase: Phase 4
• Start date: February 11, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Xijing Hospital
• Contact: Chen Yu, MD
• Phone: 13571991903
• Email: ycyc_2005[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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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Related Conditions & MeSH terms

• Acne Atrophica
• Acne Vulgaris

Intervention

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

Drug:
• Dezocine
Desocine injection was injected intravenously half an hour before surgery (10ml normal saline was added for more than 30 seconds)

Locations

Country	Name	City	State
China	Dermatology Derpartment of Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hemodynamic parameters	diastolic blood pressure (DBP), systolic blood pressure (SBP)	24 hours
Primary	Heart rate (HR)	Hemodynamic parameters	24 hours
Primary	oxygen saturation (SpO2)	Hemodynamic parameters	24 hours
Secondary	Occurrence of Adverse Reactions	Nausea, vomiting,dizziness,respiratory depression	24 hours