Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

Not Applicable

Not yet recruiting

• Conditions: Analgesia; Burns
• Interventions: Drug: Esketamine 0.1mg/kg intravenous injection; Drug: Normal saline

• Registration Number: NCT05603975
• Lead Sponsor: Shenzhen Second People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-29
• Last Update Submitted: 2022-10-29
• Study First Posted: 2022-11-03
• Last Update Posted: 2022-11-03
• Study Start: 2022-12-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EsKetamine Group	Esketamine 0.1mg/kg intravenous injection	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	Normal saline	-

Primary Outcome Measures

Name	Time	Method
The dosage of the remedy fentanyl	Within 5 minutes after the dressing change	Observe the dose of syringe solution

Secondary Outcome Measures

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