Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

NCT ID: NCT05603975

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-05-31

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.

Conditions

Analgesia; Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EsKetamine Group

The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change.

Esketamine Hydrochloride Injection 2ml：50mg

Group Type: ACTIVE_COMPARATOR

Esketamine 0.1mg/kg intravenous injection

Intervention Type: DRUG

The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change.

Control Group

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

The "Normal saline" was administered intravenously at 0.1ml per kilogram of body weight 1min before the dressing change.

Interventions

Esketamine 0.1mg/kg intravenous injection

The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change.

Intervention Type: DRUG

Normal saline

The "Normal saline" was administered intravenously at 0.1ml per kilogram of body weight 1min before the dressing change.

Intervention Type: DRUG

Other Intervention Names

Normal saline 0.1ml/kg intravenous injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

ZhiHeng Liu

Director, Head of Anesthesiology, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhiheng Liu, Dr

Role: CONTACT

15818505570@163.com

+8615818505570

Junjie Li, Master

Role: CONTACT

916281680@qq.com

+8613602587542

Other Identifiers

20223357006

Identifier Type: -

Identifier Source: org_study_id