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Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

Primary Purpose

Analgesia, Burns

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Esketamine 0.1mg/kg intravenous injection
Normal saline
Sponsored by
Shenzhen Second People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring Analgesia, Burn dressing change, Esketamine, Fentanyl, Adverse events

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) Grades II to IV Patients with severe degree burns Ages 18 to 60 Patients who signed informed consent forms Exclusion Criteria: Hepatic and renal insufficiency Allergy to intended medication History of antidepressant or antipsychotic drug use Atrioventricular block of second degree or higher Patients who can't cooperate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    EsKetamine Group

    Control Group

    Arm Description

    The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change. Esketamine Hydrochloride Injection 2ml:50mg

    Outcomes

    Primary Outcome Measures

    The dosage of the remedy fentanyl
    Observe the dose of syringe solution

    Secondary Outcome Measures

    SF-MPQ score after awakening
    Evaluate Short-Form McGill Pain Questionnaire (SF-MPQ). The SF-MPQ is a highly reliable and sensitive instrument used to asses and measure pain levels. The minimum is 0 and the maximum is 60, with a higher score indicating more severe pain.
    Incidence of sedation-related complication
    The data collector observes and ticks the type of complication
    Resuscitation time
    The data collector observed, filled in the end time of the dressing change and the time when the patient's Ramsay Sedation Scale was 1.
    Incidence of early depression
    Evaluate Hospital Anxiety Depression
    Incidence of nausea and vomiting
    Data collectors obtain data on the occurrence of events through patient or caregiver records
    Proportion of patients taking fentanyl remedies
    The proportion used is calculated from the data record
    Patient satisfaction with dressing changes
    Data collectors assessed patients using the VAS satisfaction score. The minimum is 0 and the maximum is 10, with a higher score indicating higher level of satisfaction.
    Burn physician satisfaction with the procedure
    Data collectors assessed physician using the VAS satisfaction score. The minimum is 0 and the maximum is 10, with a higher score indicating higher level of satisfaction.
    Incidence of serious complications associated with burns
    Collect data through electronic medical records

    Full Information

    First Posted
    October 20, 2022
    Last Updated
    October 29, 2022
    Sponsor
    Shenzhen Second People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05603975
    Brief Title
    Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study
    Official Title
    Analgesic Effect of Esketamine in Dressing Change for Severe Burns in Adults: a Prospective Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    April 30, 2025 (Anticipated)
    Study Completion Date
    May 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shenzhen Second People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients with severe and above degree burns are often complicated with inhalation injury and systemic infection. During debridement and dressing change in such patients, doctors will be more cautious in using analgesics. Patients often moan, shiver and limb movement due to insufficient sedation and analgesia, resulting in unpleasant feelings and experiences, which increases the anxiety of patients during hospitalization. Previous studies have shown that the use of ketamine in burn patients during dressing change can produce good analgesia and maintain stable vital signs. Esketamine, the dextral monomer of ketamine, has hypnotic, sedative and analgesic effects and could be safely used in clinical anesthesia. Compared with ketamine, esketamine has stronger analgesic efficacy and less circulatory influence, which is more consistent with the characteristics of ideal analgesic drugs in burn dressing. As an FDA-approved drug for the treatment of refractory depression, esketamine has potential social benefits in burn patients due to its rapid antidepressant pharmacological properties. This study hypothesized that esketamine could reduce the pain of dressing change in patients with severe burns and reduce the occurrence of early depression in such patients. This study adopted a prospective, double-blind, randomized, controlled, single-center design. A total of 52 severe burn patients aged 18-60 years who need debridement and dressing change under sedation and analgesia were included and randomly divided into the experiment group: esketamine would be used in the induction phase; the control group: esketamine would not be used in the induction phase. Both groups were given dexmedetomidine and butofinol before induction, and fentanyl as a remedy during the dressing change phase. The dosage of fentanyl in the dressing change phase, the pain score (SF-MPQ) after recovery, the incidence of sedation-related complication were compared between the two groups. This study explores the advantages of esketamine in reducing the use of opioids and the pain score of patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Analgesia, Burns
    Keywords
    Analgesia, Burn dressing change, Esketamine, Fentanyl, Adverse events

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    This study was double-blind, including subjects, anesthesia operators, data collectors and dressing change operators. Nurse Song Yi opened the random envelope, diluted the drugs with normal saline according to the grouping information and filled them into a 10ml syringe. The syringe was labeled (marked with subject number, name and hospitalization number), and the grouping information was destroyed after confirmation, and confidentiality was strictly observed. Fully equipped drugs are given to the anesthesiologist and empty envelopes are given to the data collector.
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EsKetamine Group
    Arm Type
    Active Comparator
    Arm Description
    The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change. Esketamine Hydrochloride Injection 2ml:50mg
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine 0.1mg/kg intravenous injection
    Intervention Description
    The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change.
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Other Intervention Name(s)
    Normal saline 0.1ml/kg intravenous injection
    Intervention Description
    The "Normal saline" was administered intravenously at 0.1ml per kilogram of body weight 1min before the dressing change.
    Primary Outcome Measure Information:
    Title
    The dosage of the remedy fentanyl
    Description
    Observe the dose of syringe solution
    Time Frame
    Within 5 minutes after the dressing change
    Secondary Outcome Measure Information:
    Title
    SF-MPQ score after awakening
    Description
    Evaluate Short-Form McGill Pain Questionnaire (SF-MPQ). The SF-MPQ is a highly reliable and sensitive instrument used to asses and measure pain levels. The minimum is 0 and the maximum is 60, with a higher score indicating more severe pain.
    Time Frame
    Within 15 minutes to 30 minutes after the patient wakes up
    Title
    Incidence of sedation-related complication
    Description
    The data collector observes and ticks the type of complication
    Time Frame
    From the beginning of the medication to the end of the dressing change, assessed up to 30 minute.
    Title
    Resuscitation time
    Description
    The data collector observed, filled in the end time of the dressing change and the time when the patient's Ramsay Sedation Scale was 1.
    Time Frame
    From the end of the dressing change to the patient's Ramsay Sedation Scale was 1, assessed up to 10 minute.
    Title
    Incidence of early depression
    Description
    Evaluate Hospital Anxiety Depression
    Time Frame
    3 days after dressing change
    Title
    Incidence of nausea and vomiting
    Description
    Data collectors obtain data on the occurrence of events through patient or caregiver records
    Time Frame
    1 days after dressing change
    Title
    Proportion of patients taking fentanyl remedies
    Description
    The proportion used is calculated from the data record
    Time Frame
    Within 5 minutes after the dressing change
    Title
    Patient satisfaction with dressing changes
    Description
    Data collectors assessed patients using the VAS satisfaction score. The minimum is 0 and the maximum is 10, with a higher score indicating higher level of satisfaction.
    Time Frame
    30 minutes to 1 hour after the patient wakes up
    Title
    Burn physician satisfaction with the procedure
    Description
    Data collectors assessed physician using the VAS satisfaction score. The minimum is 0 and the maximum is 10, with a higher score indicating higher level of satisfaction.
    Time Frame
    Within 5 minutes after the end of the dressing change
    Title
    Incidence of serious complications associated with burns
    Description
    Collect data through electronic medical records
    Time Frame
    15 days after dressing change

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) Grades II to IV Patients with severe degree burns Ages 18 to 60 Patients who signed informed consent forms Exclusion Criteria: Hepatic and renal insufficiency Allergy to intended medication History of antidepressant or antipsychotic drug use Atrioventricular block of second degree or higher Patients who can't cooperate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhiheng Liu, Dr
    Phone
    +8615818505570
    Email
    15818505570@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junjie Li, Master
    Phone
    +8613602587542
    Email
    916281680@qq.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The research protocol will be announced later in the plan.

    Learn more about this trial

    Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

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