Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

Study Overview
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Brief Summary
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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.

Official Title
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Analgesic Effect of Esketamine in Dressing Change for Severe Burns in Adults: a Prospective Randomized Controlled Study

Conditions
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Analgesia, Burns

Intervention / Treatment
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* Drug: Esketamine 0.1mg/kg intravenous injection
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EsKetamine Group<br>The Esketamine was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change. Esketamine Hydrochloride Injection 2ml：50mg | Drug: Esketamine 0.1mg/kg intravenous injection<br>* The Esketamine was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change.<br>|
| Placebo Comparator: Control Group<br> | Drug: Normal saline<br>* The Normal saline was administered intravenously at 0.1ml per kilogram of body weight 1min before the dressing change.<br>* Other names: Normal saline 0.1ml/kg intravenous injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dosage of the remedy fentanyl | Observe the dose of syringe solution | Within 5 minutes after the dressing change | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 15 minutes to 30 minutes after the patient wakes up | 
| Incidence of sedation-related complication | The data collector observes and ticks the type of complication | From the beginning of the medication to the end of the dressing change, assessed up to 30 minute. | 
| 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. | From the end of the dressing change to the patient's Ramsay Sedation Scale was 1, assessed up to 10 minute. | 
| Incidence of early depression | Evaluate Hospital Anxiety Depression | 3 days after dressing change | 
| Incidence of nausea and vomiting | Data collectors obtain data on the occurrence of events through patient or caregiver records | 1 days after dressing change | 
| Proportion of patients taking fentanyl remedies | The proportion used is calculated from the data record | Within 5 minutes after the dressing change | 
| 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. | 30 minutes to 1 hour after the patient wakes up | 
| 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. | Within 5 minutes after the end of the dressing change | 
| Incidence of serious complications associated with burns | Collect data through electronic medical records | 15 days after dressing change | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Burn dressing change, Esketamine, Fentanyl, Adverse events