Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

Shenzhen University

Status: Not yet enrolling

Conditions: Burns; Analgesia

Treatments: Drug: Normal saline; Drug: Esketamine 0.1mg/kg intravenous injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05603975

20223357006

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

EsKetamine Group

Active Comparator group

Description:

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

Treatment:

Drug: Esketamine 0.1mg/kg intravenous injection

Control Group

Placebo Comparator group

Treatment:

Drug: Normal saline