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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EsKetamine Group | Active Comparator | The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change. Esketamine Hydrochloride Injection 2ml:50mg |
|
| Control Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The dosage of the remedy fentanyl | Observe the dose of syringe solution | Within 5 minutes after the dressing change |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiheng Liu, Dr | Contact | +8615818505570 | 15818505570@163.com | |
| Junjie Li, Master | Contact | +8613602587542 | 916281680@qq.com |
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The research protocol will be announced later in the plan.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D002056 | Burns |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D007275 | Injections, Intravenous |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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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.
| Normal saline | Drug | The "Normal saline" was administered intravenously at 0.1ml per kilogram of body weight 1min before the dressing change. |
|
|
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D007267 |
| Injections |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |