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

NCT ID: NCT05861063

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-11

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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Conditions

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Acne Atrophica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type PLACEBO_COMPARATOR

Fractional CO2 laser

Intervention Type DEVICE

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

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).

Group Type EXPERIMENTAL

Fractional CO2 laser

Intervention Type DEVICE

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

Dezocine

Intervention Type DRUG

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

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).

Group Type EXPERIMENTAL

Fractional CO2 laser

Intervention Type DEVICE

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

Dezocine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DEVICE

Dezocine

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

Intervention Type DRUG

Other Intervention Names

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paronosetron hydrochloride and lidocaine cream

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gang Wang, Prof

Role: PRINCIPAL_INVESTIGATOR

Dermatology Derpartment of Xijing Hospital

Locations

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Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chen Yu, MD

Role: CONTACT

13571991903 ext. 86

Facility Contacts

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Gang Wang, prof

Role: primary

+8684775401

Other Identifiers

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XijingH-PF-20232019-F-1

Identifier Type: -

Identifier Source: org_study_id

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