Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

NCT05603975 | Unknown

• 1 other identifier: 20223357006
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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

Keywords

Analgesia; Burn dressing change; Esketamine; Fentanyl; Adverse events

Outcome Measures

Primary Outcomes (1)

• The dosage of the remedy fentanyl

  Observe the dose of syringe solution

  Within 5 minutes after the dressing change

Secondary Outcomes (9)

• SF-MPQ score after awakening

  Within 15 minutes to 30 minutes after the patient wakes up

• Incidence of sedation-related complication

  From the beginning of the medication to the end of the dressing change, assessed up to 30 minute.

• Resuscitation time

  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

  3 days after dressing change

• Incidence of nausea and vomiting

  1 days after dressing change

Study Arms (2)

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

Drug: Esketamine 0.1mg/kg intravenous injection

Control Group

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

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.

EsKetamine Group

Normal saline DRUG

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

Also known as: Normal saline 0.1ml/kg intravenous injection

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) Grades II to IV
• Patients with severe degree burns Ages 18 to 60
• Patients who signed informed consent forms

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

MeSH Terms

Conditions

Agnosia; Burns

Interventions

Esketamine; Injections, Intravenous; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Zhiheng Liu, Dr

CONTACT

+8615818505570; 15818505570@163.com

Junjie Li, Master

CONTACT

+8613602587542; 916281680@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Anesthesiology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 3, 2022
• Study Start: December 1, 2022
• Primary Completion: April 30, 2025
• Study Completion: May 31, 2025
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share