Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

Analgesic Effect of Esketamine in Dressing Change for Severe Burns in Adults: a Prospective Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burns; Analgesia
• Intervention / Treatment: Drug: Esketamine 0.1mg/kg intravenous injection; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhiheng Liu, Dr; Phone Number: +8615818505570; Email: 15818505570@163.com
• Study Contact Backup: Name: Junjie Li, Master; Phone Number: +8613602587542; Email: 916281680@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	Drug: Normal saline; The "Normal saline" was administered intravenously at 0.1ml per kilogram of body weight 1min before the dressing change.; Other Names: Normal saline 0.1ml/kg intravenous injection
Active Comparator: 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	Drug: Esketamine 0.1mg/kg intravenous injection; The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dosage of the remedy fentanyl	Observe the dose of syringe solution	Within 5 minutes after the dressing change

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): April 30, 2025
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 29, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 29, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Analgesia; Fentanyl; Adverse events; Esketamine; Burn dressing change
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: 20223357006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The research protocol will be announced later in the plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No