Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

• Sponsor: Shenzhen Second People's Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05603975
• Collaborator: (none)
• Enrollment: 52
• Arms: 2
• Anticipated Duration (Months): 30

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia; Burns	Drug: Esketamine 0.1mg/kg intravenous injection; Drug: Normal saline	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Analgesic Effect of Esketamine in Dressing Change for Severe Burns in Adults: a Prospective Randomized Controlled Study
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Apr 30, 2025
• Anticipated Study Completion Date: May 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.
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

Outcome Measures

Primary Outcome Measures

1. The dosage of the remedy fentanyl [Within 5 minutes after the dressing change]

   Observe the dose of syringe solution

Secondary Outcome Measures

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.

2. 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

3. 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.

4. Incidence of early depression [3 days after dressing change]

   Evaluate Hospital Anxiety Depression

5. Incidence of nausea and vomiting [1 days after dressing change]

   Data collectors obtain data on the occurrence of events through patient or caregiver records

6. Proportion of patients taking fentanyl remedies [Within 5 minutes after the dressing change]

   The proportion used is calculated from the data record

7. 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.

8. 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.

9. Incidence of serious complications associated with burns [15 days after dressing change]

   Collect data through electronic medical records

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shenzhen Second People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ZhiHeng Liu, Director, Head of Anesthesiology, Principal Investigator, Clinical Professor, Shenzhen Second People's Hospital
• ClinicalTrials.gov Identifier: NCT05603975
• Other Study ID Numbers: 20223357006
• First Posted: Nov 3, 2022
• Last Update Posted: Nov 3, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by ZhiHeng Liu, Director, Head of Anesthesiology, Principal Investigator, Clinical Professor, Shenzhen Second People's Hospital: Analgesia; Burn dressing change; Esketamine; Fentanyl; Adverse events
• Additional relevant MeSH terms: Burns; Esketamine

Study Results

No Results Posted as of Nov 3, 2022