Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

Ketamine

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.

Intervention / Treatment

  • Esketamine 0.1mg/kg intravenous injection (DRUG)
    The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change.
  • Normal saline (DRUG)
    The "Normal saline" was administered intravenously at 0.1ml per kilogram of body weight 1min before the dressing change.

Condition or Disease

  • Analgesia
  • Burns

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Not yet recruiting
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 52 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    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.

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2022 ESTIMATED
    Primary Completion: Apr 30, 2025 ESTIMATED
    Completion Date: May 31, 2025 ESTIMATED
    Study First Posted: Nov 03, 2022 ACTUAL
    Last Updated: Oct 29, 2022

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A

    Participant Groups

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

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Observe the dose of syringe solution

    Secondary Outcomes

    • 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.

    • The data collector observes and ticks the type of complication

    • 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.

    • Evaluate Hospital Anxiety Depression

    • Data collectors obtain data on the occurrence of events through patient or caregiver records

    • The proportion used is calculated from the data record

    • 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.

    • 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.

    • Collect data through electronic medical records

    More Details

    NCT Number: NCT05603975
    Other IDs: 20223357006
    Study URL: https://clinicaltrials.gov/study/NCT05603975
    Last updated: Sep 29, 2023